An interventional study of iDesign Refractive Studio with STAR S4 IR® Excimer laser System in Refractive Error, sponsored by AMO Development, LLC. Completed at 10 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by AMO Development, LLC · Not applicable, Interventional, and Other
This study will be a 12-month, prospective, multicenter, open-label, non-comparative, non-randomized clinical investigation conducted at 8 to 14 sites. A total of 383 subjects will be enrolled to achieve approximately 268 treated subjects, resulting in at least 241 evaluable subjects at the point of refractive stability. After signing the informed consent, subjects meeting all inclusion and exclusion criteria in both eyes may be scheduled for surgery. The follow-up visit schedule will be the same for each operative eye.
413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.
This study's enrollment of 219 is above the median of 82 across 296 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →This is the only study on the registry with AMO Development, LLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
A stable refractive error (based on a previous exam, medical records, lensometry, or prescription that is at least 12 months prior to the preoperative manifest refraction), as defined by a change of less than or equal to
Subjects with a history of contact lens wear within the last 4 weeks must discontinue lens wear in order to demonstrate refractive stability according to the following (refractive stability is defined as a change of not more than 0.50 D in manifest refraction sphere and cylinder as well as mean keratometry between measurements): After the Informed Consent process has been completed and subjects are enrolled in the study:
Agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction chosen for treatment, as follows:
Exclusion Criteria:
Women who are pregnant, breast-feeding, or intend to become pregnant during the study.
Note: Women who were pregnant or nursing may not be enrolled until 6 months after either delivery or have stopped nursing and there is documented refractive stability.
History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
NOTE: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity, or control, will specifically exclude subjects from eligibility.
History of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1 mm from limbus), retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, prior strabismus surgery, strabismus, or at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma or suspected glaucoma.
NOTE: Subjects with glaucoma, regardless of medication regimen or control, or an IOP greater than 21 mmHg at screening, are specifically excluded from eligibility.
Wavefront-guided LASIK monovision treatment of myopic subjects with presbyopia using the STAR S4 IR® Excimer laser System with the iDesign Refractive Studio.
Device: iDesign Refractive Studio with STAR S4 IR® Excimer laser System
Surgeons will perform wavefront-guided monovision LASIK for the treatment of myopic subjects with presbyopia based upon measurements obtained with an iDesign Refractive Studio.
Change in Driving Scale Score From Preoperative to Postoperative as Measured by Driving Scale Within Patient-Reported Outcomes With LASIK for Monovision (PROWL-M)
Change in driving scale score from preoperative to postoperative as measured by driving scale within PROWL-M was reported. PROWL-M driving scale consists of three driving related items that were used to generate the driving scale score. Each item response was converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 (not functioning) and 100 (functioning) points. A high score represents better functioning. The composite driving scale score was calculated by averaging the scores of all the three items, resulting in a total score ranging from 0 to 100 where higher score represent better functioning. Change in driving scale score was defined as the driving scale score at 12-month visit minus the driving scale score at preoperative visit.
Time frame: From preoperative (within 120 to 14 days prior to surgery on Day 0) to 12 month postoperative (operated on Day 0)
Percentage of Participants Who Required Secondary Surgery to Reverse Monovision
Percentage of participants who required secondary surgery to reverse monovision was reported.
Time frame: At 12 month postoperative (operated on Day 0)
Percentage of Participants Who Experienced Bothersome Visual Symptom (Double Image) as Assessed by PROWL-M: In Last 7 Days, How Bothersome Have the Symptoms Been When Wearing the Best Vision Correction (Glasses or Contact Lenses)?
Percentage of participants who experienced bothersome visual symptom (double image) as assessed by PROWL-M (in Last 7 Days, how bothersome have the symptoms been when wearing the best vision correction \[glasses or contact lenses\]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In last 7 days how bothersome have the double images symptoms been when wearing the best vision correction" of double images was categorize as: (1) participant do not use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
Time frame: 3 months, 6 months, 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Bothersome Visual Symptom (Double Image) as Assessed by PROWL-M: In Last 7 Days, How Bothersome Have the Symptoms Been When Not Wearing Any Vision Correction (Glasses or Contact Lenses)?
Percentage of participants who experienced bothersome visual symptom (double image) as assessed by PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when not wearing any vision correction \[glasses or contact lenses\]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the double images been symptoms been when not wearing any vision correction (glasses or contact lenses)" was categorize as: (1) participant always use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
Time frame: 3 months, 6 months, 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Bothersome Visual Symptom (Glare) as Assessed by PROWL-M: In the Last 7 Days How Bothersome Have the Symptoms Been When Wearing the Best Vision Correction (Glasses or Contact Lenses)?
Percentage of participants who experienced bothersome visual symptom (glare) as assessed by PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when wearing the best vision correction \[glasses or contact lenses\]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the glare been when wearing the best vision correction (glasses or contact lenses)" was categorize as: (1) participant do not use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
Time frame: 3 months, 6 months, 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Bothersome Visual Symptom (Glare) as Assessed by PROWL-M: In the Last 7 Days How Bothersome Have the Symptoms Been When Not Wearing Any Vision Correction (Glasses or Contact Lenses)?
Percentage of participants who experienced bothersome visual symptom (glare) as assessed by PROWL-M questionnaire was reported. The PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when not wearing any vision correction \[glasses or contact lenses\]) was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the glare been when not wearing any vision correction (glasses or contact lenses)" was categorize as: (1) participant always use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
Time frame: 3 months, 6 months, 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Bothersome Visual Symptom (Halo) as Assessed by PROWL-M: In the Last 7 Days How Bothersome Have the Symptoms Been When Wearing the Best Vision Correction (Glasses or Contact Lenses)?
Percentage of participants who experienced bothersome visual symptom (halo) as assessed by PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when wearing the best vision correction \[glasses or contact lenses\]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the Halos been when wearing the best vision correction (glasses or contact lenses)" was categorize as: (1) participant do not use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
Time frame: 3 months, 6 months, 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Bothersome Visual Symptom (Halo) as Assessed by PROWL-M: In the Last 7 Days How Bothersome Have the Symptoms Been When Not Wearing Any Vision Correction (Glasses or Contact Lenses)?
Percentage of participants who experienced bothersome visual symptom (halo) as assessed by PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when not wearing any vision correction \[glasses or contact lenses\]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the halos been when not wearing any vision correction (glasses or contact lenses)" was categorize as: (1) participant always use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
Time frame: 3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Bothersome Visual Symptom (Starbursts) as Assessed by PROWL-M: In the Last 7 Days How Bothersome Have the Symptoms Been When Wearing the Best Vision Correction (Glasses or Contact Lenses)?
Percentage of participants who experienced bothersome visual symptom (starbursts) as assessed by PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when wearing the best vision correction \[glasses or contact lenses\]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the starbursts been when wearing the best vision correction (glasses or contact lenses)" was categorize as: (1) participant do not use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
Time frame: 3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Bothersome Visual Symptom (Starbursts) as Assessed by PROWL-M: In the Last 7 Days How Bothersome Have the Symptom Been When Not Wearing Any Vision Correction (Glasses or Contact Lenses)?
Percentage of participants who experienced bothersome visual symptom (starbursts) as assessed by PROWL-M questionnaire (in Last 7 Days, how bothersome have the symptoms been when not wearing any vision correction \[glasses or contact lenses\]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the starbursts been when not wearing any vision correction (glasses or contact lenses)" was categorize as: (1) participant always use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
Time frame: 3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Moderate to Severe Difficulty in Activities
Percentage of participants who experienced moderate to severe difficulty in activities was reported. Participants were asked questions about the difficulty they faced with daily activities, work or hobbies, reading, and judging distances. Responses was collected in 6 categories: (1) No difficulty at all, (2) A little difficulty, (3) moderate difficulty, (4) a lot of difficulty, (5) never try to do these activities because of vision, (6) Never do these activities for other reasons. Categories with non-zero data values are reported.
Time frame: Preoperative (within 120 to 14 days prior to surgery on Day 0), 3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Satisfaction With Vision as Measured by PROWL-M Questionnaire
Percentage of participants who experienced satisfaction with vision was reported. Satisfaction with vision was assessed using a single-item question in the PROWL-M questionnaire. Participants were asked a question "In general, how satisfied or dissatisfied are you with your present vision". Responses was collected in 6 categories: (1) completely satisfied, (2) very satisfied, (3) somewhat satisfied, (4) somewhat dissatisfied, (5) very dissatisfied, (6) completely dissatisfied. Categories with non-zero data values are reported.
Time frame: Preoperative (within 120 to 14 days prior to surgery on Day 0), 3 months, 6 months, and 12 months postoperative (operated on Day 0)
Subject Satisfaction Score With Surgery as Measured by PROWL-M Questionnaire
A questionnaire derived from the PROWL-M was given to participants after surgery. Satisfaction with LASIK via PROWL-M questionnaire was assessed with 8 items. Responses to individual items were linearly transformed to a 0 to 100 scale where 100 indicates best possible vision and satisfaction, while 0 indicates worst possible vision and satisfaction. Each item score was averaged together to produce a score ranging from 0 to 100. A higher score indicating greater satisfaction.
Time frame: 3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of Participants Who Achieved 20/40 Or Better Simultaneous Binocular Uncorrected Visual Acuity (UCVA)
Percentage of participants who achieved 20/40 or better simultaneous binocular UCVA measured using Good-Lite 100 percent (%) proportionally spaced SLOAN letter/ETDRS charts designed for 4.0 meter (m) and the Good-Lite self-illuminated and self-calibrated illumination box were reported.
Time frame: Preoperative (within 120 to 14 days prior to surgery on Day 0), 3 months, 6 months, and 12 months postoperative (operated on Day 0)
| Milestone | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| Started | 219 |
| Safety analysis set | 159 |
| Completed | 153 |
| Not completed | 66 |
| Withdrew: Enrolled but not treated | 60 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Non-johnson & johnson device used | 3 |
| Withdrew: Retreatment not done using idesign | 1 |
| Withdrew: Participants requested surgical intervention for vision complaints | 1 |
Change in driving scale score from preoperative to postoperative as measured by driving scale within PROWL-M was reported. PROWL-M driving scale consists of three driving related items that were used to generate the driving scale score. Each item response was converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 (not functioning) and 100 (functioning) points. A high score represents better functioning. The composite driving scale score was calculated by averaging the scores of all the three items, resulting in a total score ranging from 0 to 100 where higher score represent better functioning. Change in driving scale score was defined as the driving scale score at 12-month visit minus the driving scale score at preoperative visit.
| Score on a scale | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| Change in Driving Scale Score From Preoperative to Postoperative as Measured by Driving Scale Within Patient-Reported Outcomes With LASIK for Monovision (PROWL-M) | 1.8 ± 16.63 |
Percentage of participants who required secondary surgery to reverse monovision was reported.
| Percentage of participants | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| Percentage of Participants Who Required Secondary Surgery to Reverse Monovision | 0 |
Percentage of participants who experienced bothersome visual symptom (double image) as assessed by PROWL-M (in Last 7 Days, how bothersome have the symptoms been when wearing the best vision correction \[glasses or contact lenses\]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In last 7 days how bothersome have the double images symptoms been when wearing the best vision correction" of double images was categorize as: (1) participant do not use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
| Percentage of participants | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| 3 months: participant do not use glasses or contact lenses | 0.6 |
| 3 months: Extremely bothersome | 0.6 |
| 3 months: Very bothersome | 0 |
| 3 months: Somewhat bothersome | 0 |
| 3 months: A little bothersome | 0.6 |
| 3 months: Not at all bothersome | 0 |
| 3 month: participants who did not experience symptom | 98.1 |
| 6 months: participant do not use glasses or contact lenses | 0.6 |
| 6 months: Extremely bothersome | 0.6 |
| 6 months: Very bothersome | 0.6 |
| 6 months: Somewhat bothersome | 0 |
| 6 months: A little bothersome | 0.6 |
| 6 months: Not at all bothersome | 0 |
| 6 month: participants who did not experience symptom | 97.5 |
| 12 months: participant do not use glasses or contact lenses | 0.6 |
| 12 months: Extremely bothersome | 0.6 |
| 12 months: Very bothersome | 0.6 |
| 12 months: Somewhat bothersome | 0 |
| 12 months: A little bothersome | 0.6 |
| 12 months: Not at all bothersome | 0.6 |
| 12 month: participants who did not experience symptom | 96.9 |
Percentage of participants who experienced bothersome visual symptom (double image) as assessed by PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when not wearing any vision correction \[glasses or contact lenses\]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the double images been symptoms been when not wearing any vision correction (glasses or contact lenses)" was categorize as: (1) participant always use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
| Percentage of participants | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| 3 months: participant always use glasses or contact lenses | 0.6 |
| 3 months: Extremely bothersome | 0.6 |
| 3 months: Very bothersome | 0 |
| 3 months: Somewhat bothersome | 1.3 |
| 3 months: A little bothersome | 7.6 |
| 3 months: Not at all bothersome | 0 |
| 3 month: participants who did not experience symptom | 89.8 |
| 6 months: participant always use glasses or contact lenses | 1.3 |
| 6 months: Extremely bothersome | 0.6 |
| 6 months: Very bothersome | 0.6 |
| 6 months: Somewhat bothersome | 2.5 |
| 6 months: A little bothersome | 7.5 |
| 6 months: Not at all bothersome | 0.6 |
| 6 month: participants who did not experience symptom | 86.8 |
| 12 months: participant always use glasses or contact lenses | 0.6 |
| 12 months: Extremely bothersome | 0.6 |
| 12 months: Very bothersome | 1.3 |
| 12 months: Somewhat bothersome | 4.4 |
| 12 months: A little bothersome | 6.9 |
| 12 months: Not at all bothersome | 1.3 |
| 12 month: participants who did not experience symptom | 84.9 |
Percentage of participants who experienced bothersome visual symptom (glare) as assessed by PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when wearing the best vision correction \[glasses or contact lenses\]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the glare been when wearing the best vision correction (glasses or contact lenses)" was categorize as: (1) participant do not use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
| Percentage of participants | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| 3 months: participant do not use glasses or contact lenses | 5.1 |
| 3 months: Extremely bothersome | 0 |
| 3 months: Very bothersome | 1.3 |
| 3 months: Somewhat bothersome | 1.3 |
| 3 months: A little bothersome | 1.3 |
| 3 months: Not at all bothersome | 0 |
| 3 month: participants who did not experience symptom | 91.1 |
| 6 months: participant do not use glasses or contact lenses | 9.4 |
| 6 months: Extremely bothersome | 0 |
| 6 months: Very bothersome | 1.3 |
| 6 months: Somewhat bothersome | 1.9 |
| 6 months: A little bothersome | 3.1 |
| 6 months: Not at all bothersome | 0 |
| 6 month: participants who did not experience symptom | 84.3 |
| 12 months: participant do not use glasses or contact lenses | 10.1 |
| 12 months: Extremely bothersome | 0 |
| 12 months: Very bothersome | 1.3 |
| 12 months: Somewhat bothersome | 1.9 |
| 12 months: A little bothersome | 4.4 |
| 12 months: Not at all bothersome | 0.6 |
| 12 month: participants who did not experience symptom | 81.8 |
Percentage of participants who experienced bothersome visual symptom (glare) as assessed by PROWL-M questionnaire was reported. The PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when not wearing any vision correction \[glasses or contact lenses\]) was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the glare been when not wearing any vision correction (glasses or contact lenses)" was categorize as: (1) participant always use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
| Percentage of participants | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| 3 months: participant always use glasses or contact lenses | 0.6 |
| 3 months: Extremely bothersome | 0 |
| 3 months: Very bothersome | 1.3 |
| 3 months: Somewhat bothersome | 3.8 |
| 3 months: A little bothersome | 10.2 |
| 3 months: Not at all bothersome | 4.5 |
| 3 month: participants who did not experience symptom | 79.6 |
| 6 months: participant always use glasses or contact lenses | 1.9 |
| 6 months: Extremely bothersome | 0 |
| 6 months: Very bothersome | 0.6 |
| 6 months: Somewhat bothersome | 6.9 |
| 6 months: A little bothersome | 15.1 |
| 6 months: Not at all bothersome | 5.0 |
| 6 month: participants who did not experience symptom | 70.4 |
| 12 months: participant always use glasses or contact lenses | 1.3 |
| 12 months: Extremely bothersome | 0 |
| 12 months: Very bothersome | 1.3 |
| 12 months: Somewhat bothersome | 3.8 |
| 12 months: A little bothersome | 20.8 |
| 12 months: Not at all bothersome | 6.3 |
| 12 month: participants who did not experience symptom | 66.7 |
Percentage of participants who experienced bothersome visual symptom (halo) as assessed by PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when wearing the best vision correction \[glasses or contact lenses\]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the Halos been when wearing the best vision correction (glasses or contact lenses)" was categorize as: (1) participant do not use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
| Percentage of participants | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| 3 months: participant do not use glasses or contact lenses | 3.2 |
| 3 months: Extremely bothersome | 0 |
| 3 months: Very bothersome | 0.6 |
| 3 months: Somewhat bothersome | 1.9 |
| 3 months: A little bothersome | 4.5 |
| 3 months: Not at all bothersome | 0.6 |
| 3 month: participants who did not experience symptom | 89.2 |
| 6 months: participant do not use glasses or contact lenses | 4.4 |
| 6 months: Extremely bothersome | 0 |
| 6 months: Very bothersome | 0.6 |
| 6 months: Somewhat bothersome | 2.5 |
| 6 months: A little bothersome | 6.3 |
| 6 months: Not at all bothersome | 1.3 |
| 6 month: participants who did not experience symptom | 84.9 |
| 12 months: participant do not use glasses or contact lenses | 8.2 |
| 12 months: Extremely bothersome | 0 |
| 12 months: Very bothersome | 0.6 |
| 12 months: Somewhat bothersome | 1.9 |
| 12 months: A little bothersome | 8.8 |
| 12 months: Not at all bothersome | 1.9 |
| 12 month: participants who did not experience symptom | 78.6 |
Percentage of participants who experienced bothersome visual symptom (halo) as assessed by PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when not wearing any vision correction \[glasses or contact lenses\]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the halos been when not wearing any vision correction (glasses or contact lenses)" was categorize as: (1) participant always use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
| Percentage of participants | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| 3 months: participants always use glasses or contact lenses | 1.3 |
| 3 months: Extremely bothersome | 0 |
| 3 months: Very bothersome | 0 |
| 3 months: Somewhat bothersome | 7.0 |
| 3 months: A little bothersome | 18.5 |
| 3 months: Not at all bothersome | 8.9 |
| 3 months: participants who did not experience symptom | 64.3 |
| 6 months: participants always use glasses or contact lenses | 2.5 |
| 6 months: Extremely bothersome | 0 |
| 6 months: Very bothersome | 0 |
| 6 months: Somewhat bothersome | 9.4 |
| 6 months: A little bothersome | 20.1 |
| 6 months: Not at all bothersome | 13.8 |
| 6 months: participants who did not experience symptom | 54.1 |
| 12 months: participants always use glasses or contact lenses | 1.9 |
| 12 months: Extremely bothersome | 0 |
| 12 months: Very bothersome | 0 |
| 12 months: Somewhat bothersome | 6.9 |
| 12 months: A little bothersome | 25.8 |
| 12 months: Not at all bothersome | 15.7 |
| 12 months: participants who did not experience symptom | 49.7 |
Percentage of participants who experienced bothersome visual symptom (starbursts) as assessed by PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when wearing the best vision correction \[glasses or contact lenses\]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the starbursts been when wearing the best vision correction (glasses or contact lenses)" was categorize as: (1) participant do not use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
| Percentage of participants | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| 3 months: participants do not use glasses or contact lenses | 2.5 |
| 3 months: Extremely bothersome | 0 |
| 3 months: Very bothersome | 0.6 |
| 3 months: Somewhat bothersome | 1.9 |
| 3 months: A little bothersome | 4.5 |
| 3 months: Not at all bothersome | 1.3 |
| 3 months: participants who did not experience symptom | 89.2 |
| 6 months: participants do not use glasses or contact lenses | 7.5 |
| 6 months: Extremely bothersome | 0 |
| 6 months: Very bothersome | 1.3 |
| 6 months: Somewhat bothersome | 2.5 |
| 6 months: A little bothersome | 6.3 |
| 6 months: Not at all bothersome | 1.9 |
| 6 months: participants who did not experience symptom | 80.5 |
| 12 months: participants do not use glasses or contact lenses | 8.8 |
| 12 months: Extremely bothersome | 0 |
| 12 months: Very bothersome | 0.6 |
| 12 months: Somewhat bothersome | 3.1 |
| 12 months: A little bothersome | 7.5 |
| 12 months: Not at all bothersome | 3.1 |
| 12 months: participants who did not experience symptom | 76.8 |
Percentage of participants who experienced bothersome visual symptom (starbursts) as assessed by PROWL-M questionnaire (in Last 7 Days, how bothersome have the symptoms been when not wearing any vision correction \[glasses or contact lenses\]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the starbursts been when not wearing any vision correction (glasses or contact lenses)" was categorize as: (1) participant always use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
| Percentage of participants | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| 3 months: Participants always use glasses or contact lenses | 0 |
| 3 months: Extremely bothersome | 0.6 |
| 3 months: Very bothersome | 1.3 |
| 3 months: Somewhat bothersome | 8.3 |
| 3 months: A little bothersome | 19.1 |
| 3 months: Not at all bothersome | 14.6 |
| 3 months: participants who did not experience symptom | 56.1 |
| 6 months: Participants always use glasses or contact lenses | 1.3 |
| 6 months: Extremely bothersome | 0 |
| 6 months: Very bothersome | 0.6 |
| 6 months: Somewhat bothersome | 8.2 |
| 6 months: A little bothersome | 23.9 |
| 6 months: Not at all bothersome | 18.9 |
| 6 months: participants who did not experience symptom | 47.2 |
| 12 months: Participants always use glasses or contact lenses | 0.6 |
| 12 months: Extremely bothersome | 0 |
| 12 months: Very bothersome | 2.5 |
| 12 months: Somewhat bothersome | 5.0 |
| 12 months: A little bothersome | 32.1 |
| 12 months: Not at all bothersome | 22.0 |
| 12 months: participants who did not experience symptom | 37.7 |
Percentage of participants who experienced moderate to severe difficulty in activities was reported. Participants were asked questions about the difficulty they faced with daily activities, work or hobbies, reading, and judging distances. Responses was collected in 6 categories: (1) No difficulty at all, (2) A little difficulty, (3) moderate difficulty, (4) a lot of difficulty, (5) never try to do these activities because of vision, (6) Never do these activities for other reasons. Categories with non-zero data values are reported.
| Percentage of participants | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| Difficulty with daily activities: no difficulty at all: Preoperative | 71.1 |
| Difficulty with daily activities: a little difficulty: Preoperative | 23.3 |
| Difficulty with daily activities: moderate difficulty: Preoperative | 4.4 |
| Difficulty with daily activities: a lot of difficulty: Preoperative | 1.3 |
| Difficulty with daily activities: no difficulty at all: 3 months | 74.5 |
| Difficulty with daily activities: a little difficulty: 3 months | 23.6 |
| Difficulty with daily activities: moderate difficulty: 3 months | 1.9 |
| Difficulty with daily activities: no difficulty at all: 6 months | 82.7 |
| Difficulty with daily activities: a little difficulty: 6 months | 17.3 |
| Difficulty with daily activities: no difficulty at all: 12 months | 85.0 |
| Difficulty with daily activities: a little difficulty: 12 months | 15.0 |
| Difficulty during work or hobbies: no difficulty at all: preoperative | 39.0 |
| Difficulty during work or hobbies: a little difficulty: preoperative | 42.8 |
| Difficulty during work or hobbies: moderate difficulty: preoperative | 13.8 |
| Difficulty during work or hobbies: a lot of difficulty: preoperative | 4.4 |
| Difficulty during work or hobbies: no difficulty at all: 3 months | 49.7 |
| Difficulty during work or hobbies: a little difficulty: 3 months | 38.2 |
| Difficulty during work or hobbies: moderate difficulty: 3 months | 8.9 |
| Difficulty during work or hobbies: a lot of difficulty: 3 months | 3.2 |
| Difficulty during work or hobbies: no difficulty at all: 6 months | 54.7 |
| Difficulty during work or hobbies: a little difficulty: 6 months | 34.7 |
| Difficulty during work or hobbies: moderate difficulty: 6 months | 8.0 |
| Difficulty during work or hobbies: a lot of difficulty: 6 months | 2.7 |
| Difficulty during work or hobbies: no difficulty at all: 12 months | 54.2 |
| Difficulty during work or hobbies: a little difficulty: 12 months | 35.3 |
| Difficulty during work or hobbies: moderate difficulty: 12 months | 8.5 |
| Difficulty during work or hobbies: a lot of difficulty: 12 months | 2.0 |
| Difficulty reading small print: no difficulty at all: Preoperative | 27.7 |
| Difficulty reading small print: a little difficulty: Preoperative | 37.7 |
| Difficulty reading small print: moderate difficulty: Preoperative | 21.4 |
| Difficulty reading small print: a lot of difficulty: Preoperative | 12.6 |
| Difficulty reading small print: never try to do this because of vision: Preoperative | 0.6 |
| Difficulty reading small print: no difficulty at all: 3 months | 34.4 |
| Difficulty reading small print: a little difficulty: 3 months | 40.1 |
| Difficulty reading small print: moderate difficulty: 3 months | 17.2 |
| Difficulty reading small print: a lot of difficulty: 3 months | 8.3 |
| Difficulty reading small print: no difficulty at all: 6 months | 36.0 |
| Difficulty reading small print: a little difficulty: 6 months | 39.3 |
| Difficulty reading small print: moderate difficulty: 6 months | 16.0 |
| Difficulty reading small print: a lot of difficulty: 6 months | 8.0 |
| Difficulty reading small print: never try to do this because of vision: 6 months | 0.7 |
| Difficulty reading small print: no difficulty at all: 12 months | 35.3 |
| Difficulty reading small print: a little difficulty: 12 months | 45.8 |
| Difficulty reading small print: moderate difficulty: 12 months | 12.4 |
| Difficulty reading small print: a lot of difficulty: 12 months | 5.9 |
| Difficulty reading small print: never try to do this because of vision: 12 months | 0.7 |
| Difficulty judging distances: no difficulty at all: preoperative | 83.0 |
| Difficulty judging distances: a little difficult: preoperative | 13.8 |
| Difficulty judging distances: moderate difficult: preoperative | 2.5 |
| Difficulty judging distances: a lot of difficult: preoperative | 0.6 |
| Difficulty judging distances: no difficulty at all: 3 months | 90.4 |
| Difficulty judging distances: a little difficulty: 3 months | 9.6 |
| Difficulty judging distances: no difficulty at all: 6 months | 89.3 |
| Difficulty judging distances: a little difficulty: 6 months | 9.3 |
| Difficulty judging distances: moderate difficulty: 6 months | 1.3 |
| Difficulty judging distances: no difficulty at all: 12 months | 88.2 |
| Difficulty judging distances: a little difficulty: 12 months | 11.8 |
Percentage of participants who experienced satisfaction with vision was reported. Satisfaction with vision was assessed using a single-item question in the PROWL-M questionnaire. Participants were asked a question "In general, how satisfied or dissatisfied are you with your present vision". Responses was collected in 6 categories: (1) completely satisfied, (2) very satisfied, (3) somewhat satisfied, (4) somewhat dissatisfied, (5) very dissatisfied, (6) completely dissatisfied. Categories with non-zero data values are reported.
| Percentage of participants | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| Completely satisfied: Preoperative | 11.9 |
| Very satisfied: Preoperative | 36.5 |
| Somewhat satisfied: Preoperative | 24.5 |
| Somewhat dissatisfied: Preoperative | 10.7 |
| Very dissatisfied: Preoperative | 13.8 |
| Completely dissatisfied: Preoperative | 2.5 |
| Completely satisfied: 3 months | 32.5 |
| Very satisfied: 3 months | 46.5 |
| Somewhat satisfied: 3 months | 14.6 |
| Somewhat dissatisfied: 3 months | 3.8 |
| Very dissatisfied: 3 months | 1.9 |
| Completely dissatisfied: 3 months | 0.6 |
| Completely satisfied: 6 months | 40.7 |
| Very satisfied: 6 months | 42.0 |
| Somewhat satisfied: 6 months | 12.7 |
| Somewhat dissatisfied: 6 months | 1.3 |
| Very dissatisfied: 6 months | 2.7 |
| Completely dissatisfied: 6 months | 0.7 |
| Completely satisfied: 12 months | 43.8 |
| Very satisfied: 12 months | 47.1 |
| Somewhat satisfied: 12 months | 5.2 |
| Somewhat dissatisfied: 12 months | 2.6 |
| Very dissatisfied: 12 months | 1.3 |
A questionnaire derived from the PROWL-M was given to participants after surgery. Satisfaction with LASIK via PROWL-M questionnaire was assessed with 8 items. Responses to individual items were linearly transformed to a 0 to 100 scale where 100 indicates best possible vision and satisfaction, while 0 indicates worst possible vision and satisfaction. Each item score was averaged together to produce a score ranging from 0 to 100. A higher score indicating greater satisfaction.
| Score on a scale | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| 3 months | 83.5 ± 19.5 |
| 6 months | 86.2 ± 18.2 |
| 12 months | 89.7 ± 13.9 |
Percentage of participants who achieved 20/40 or better simultaneous binocular UCVA measured using Good-Lite 100 percent (%) proportionally spaced SLOAN letter/ETDRS charts designed for 4.0 meter (m) and the Good-Lite self-illuminated and self-calibrated illumination box were reported.
| Percentage of participants | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| Preoperative | 18.2 |
| 3 months | 93.6 |
| 6 months | 95.3 |
| 12 months | 96.1 |
Collected over From preoperative (within 120 to 14 days prior to surgery on Day 0) up to 12 months postoperative (operated on Day 0). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Wavefront-guided LASIK Monovision Treatment | 0/159 (0%) | 0/159 (0%) | 8/159 (5%) |
| Event | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| Decrease in Best Spectacle Corrected Visual AcuitySurgical and medical procedures | 8/159 |
Safety analysis set included all participants who underwent the procedure.
| Age, Continuous(Years) | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| Mean | 49.6 ± 4.6 |
| Sex: Female, Male(Participants) | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| Female | 112 |
| Male | 47 |
| Ethnicity (NIH/OMB)(Participants) | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| Hispanic or Latino | 18 |
| Not Hispanic or Latino | 141 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | Wavefront-guided LASIK Monovision Treatment |
|---|---|
| Asian | 1 |
| Black | 7 |
| Caucasian | 151 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.