An interventional study of Intralase IFS150 and Visumax in Myopia and Astigmatism, sponsored by Edward E. Manche. Completed at 1 site in United States. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-14.
Sponsored by Edward E. Manche · Not applicable, Interventional, and Treatment
Comparing LASIK outcomes using two femtosecond lasers
Patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the patient from the study, then the investigator will inform the patient and make an appropriate referral. Patients deemed appropriate for the study after a comprehensive examination including computerized videokeratography can be enrolled. Patients will undergo bilateral simultaneous eye surgery. Which eye is treated with the Intralase IFS 150 and which eye is treated with VisuMax will be randomized so there is a 50% chance for either eye to receive one treatment. Patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. Patients will receive topical antibiotics in each eye for one week following the procedure. Patients will receive pred forte 1% ophthalmic drops for one week after treatment. Patients will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.
1,007 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 7 is below the median of 80 across 803 interventional studies indexed under Myopia.
Browse Myopia studies →Edward E. Manche is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intralase IFS vs. Visumax
Device: Intralase IFS150
Visumax vs. Intralase iFS
Device: Visumax
Intralase flap creation
Visumax flap creation
ETDRS Uncorrected Visual Acuity
Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts
Time frame: At post-operative month 12
Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness
Anterior segment ocular coherence tomography
Time frame: At postoperative month one
Cochet Bonnet Asthesiometry Measurement of Corneal Sensation
Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal.
Time frame: At postoperative month twelve
Best Spectacle Corrected Visual Acuity
Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts
Time frame: Postoperative month 12
Aberrometry
Aberrometry images will be obtained on the iDesign aberrometer
Time frame: One three, six and twelve months
Questionnaire Measuring Patient Preference for Laser Device
Participants were asked if they preferred having LASIK surgery with either the Visumax laser, the Intralase iFS laser or had no preference between the two lasers.
Time frame: Intraoperative (Approximately 1 minute after completion of surgery)
Patient Reported Outcomes With LASIK
PROWL study questionnaire
Time frame: One month, three months, six months and twelve months
| Milestone | Intralase IFS Eye | Visumax Eye |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 7 |
| Not completed | 0 | 0 |
Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts
| Eyes | Intralase IFS Eye | Visumax Eye |
|---|---|---|
| ETDRS Uncorrected Visual Acuity | 5 | 5 |
Anterior segment ocular coherence tomography
No measurements were reported for this outcome.
Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal.
| Eyes | Intralase IFS Eye | Visumax Eye |
|---|---|---|
| Score of greater than or equal to 5 | 7 | 7 |
| Score of less than 5 | 0 | 0 |
Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts
| Eyes | Intralase IFS Eye | Visumax Eye |
|---|---|---|
| Best Spectacle Corrected Visual Acuity | 0 | 0 |
Aberrometry images will be obtained on the iDesign aberrometer
No measurements were reported for this outcome.
Participants were asked if they preferred having LASIK surgery with either the Visumax laser, the Intralase iFS laser or had no preference between the two lasers.
| Participants | All Participants |
|---|---|
| Preferred Visumax | 3 |
| Preferred Intralase IFS | 2 |
| No preference | 2 |
PROWL study questionnaire
No measurements were reported for this outcome.
Collected over Twelve months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intralase IFS Eye | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Visumax Eye | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 6 |
| Male | 1 |
| Race/Ethnicity, Customized(Participants) | All Participants |
|---|---|
| Asian | 5 |
| Caucasian | 2 |
| Region of Enrollment(Participants) | All Participants |
|---|---|
| United States | 7 |
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Plan to share: No
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Edward E. Manche