An interventional study of Laser Blended Vision LASIK and Traditional Monovision LASIK in Presbyopia and Refractive Error, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 40 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if laser blended vision (LBV) works better than traditional monovision LASIK to correct presbyopia in adults aged 40 to 55 years. Presbyopia is an age-related condition that makes it hard to see things up close. The study will also evaluate the safety of both procedures.
The main questions it aims to answer are:
Does LBV improve distance, intermediate, and near vision at the same time after surgery? Is LBV as safe as traditional monovision LASIK?
Researchers will compare laser blended vision to traditional monovision LASIK to see if LBV provides better overall vision after surgery.
Participants will:
Be randomly assigned to receive either laser blended vision or traditional monovision LASIK Have standard eye examinations before surgery Undergo LASIK surgery using the assigned method Return for follow-up visits at 1 week, 1 month, 3 months, and 6 months after surgery Complete vision tests and questionnaires about visual quality and satisfaction
Presbyopia is an age-related condition that causes difficulty seeing at near distance and often leads to visual fatigue and dependence on reading glasses. Corneal refractive surgery has become an option for presbyopia correction. Traditional monovision LASIK corrects one eye for distance and the other eye for near vision, but some people may experience reduced depth perception or visual discomfort. Laser blended vision (LBV) is a modified LASIK technique designed to increase depth of focus and improve vision at multiple distances while maintaining binocular visual function. However, high-quality randomized clinical trials comparing LBV with traditional monovision LASIK are limited.
The purpose of this study is to compare the visual outcomes and safety of laser blended vision and traditional monovision LASIK in adults with presbyopia.
This study is a single-center, randomized, parallel-group clinical trial. About 100 participants aged 40 to 55 years who are suitable for LASIK surgery will be enrolled. Participants will be randomly assigned in a one-to-one ratio to receive either laser blended vision or traditional monovision LASIK.
All surgeries will be performed using standard LASIK procedures by experienced surgeons. Participants will undergo routine eye examinations before surgery and will be followed after surgery at scheduled visits, including 1 week, 1 month, 3 months, and 6 months.
The main evaluation will assess whether participants achieve good uncorrected distance, intermediate, and near vision at 6 months after surgery. Additional assessments will include refractive accuracy, visual quality, stereopsis, contrast sensitivity, patient-reported visual function, and safety outcomes.
336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.
This study's planned enrollment of 100 is above the median of 61 across 276 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo laser blended vision LASIK. The dominant eye will be corrected for distance vision, and the non-dominant eye will be targeted for mild myopia to improve near vision using a laser blended vision design.
Procedure: Laser Blended Vision LASIK
Participants will receive standard monovision LASIK for presbyopia correction, with the dominant eye corrected for distance and the non-dominant eye targeted for mild myopia to improve near vision.
Procedure: Traditional Monovision LASIK
Laser blended vision LASIK is a refractive surgery technique for presbyopia correction. The dominant eye is corrected for distance vision, and the non-dominant eye is adjusted to mild myopia to improve near vision using a laser blended vision design.
Monovision LASIK is a refractive surgery technique in which the dominant eye is corrected for distance vision and the non-dominant eye is corrected for near vision to improve presbyopia.
Proportion of participants achieving target binocular visual acuity at multiple distances
Proportion of participants who achieve binocular uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), and uncorrected near visual acuity (UNVA) of 0.8 (logMAR 0.10) or better.
Time frame: 6 months after surgery
Binocular uncorrected visual acuity
Binocular uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), and uncorrected near visual acuity (UNVA) will be measured at scheduled follow-up visits.
Time frame: 1 week, 1 month, 3 months, and 6 months after surgery
Refractive accuracy after surgery
Refractive accuracy will be evaluated using the difference between achieved and target refraction and the proportion of eyes within predefined refractive ranges.
Time frame: 1 week, 1 month, 3 months, and 6 months after surgery
Refractive stability over time
Refractive stability will be assessed by changes in spherical equivalent during follow-up visits.
Time frame: Up to 6 months after surgery
Contrast sensitivity
Contrast sensitivity will be measured using a standardized contrast sensitivity testing system (CSV-1000, VectorVision, USA) at multiple spatial frequencies.
Time frame: 1 week, 1 month, 3 months, and 6 months after surgery
Stereoacuity
Stereoacuity will be measured using a standardized stereopsis test (Randot Stereo Test) at near distance to evaluate binocular visual function.
Time frame: 1 week, 1 month, 3 months, and 6 months after surgery
NEI Visual Function Questionnaire-25 (NEI VFQ-25)
Vision-related quality of life will be assessed using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25). The questionnaire includes multiple domains related to visual function and daily activities. Scores range from 0 to 100, with higher scores indicating better visual function.
Time frame: 1 week, 1 month, 3 months, and 6 months after surgery
Quality of Vision (QoV) questionnaire
Visual symptoms will be assessed using the Quality of Vision (QoV) questionnaire, which evaluates the frequency, severity, and bothersome nature of visual disturbances such as glare, halos, starbursts, blur, and visual distortion. Responses are recorded on ordinal scales, and higher scores indicate worse visual quality.
Time frame: 1 month, 3 months, and 6 months after surgery
Spectacle independence
Spectacle independence will be assessed using a structured questionnaire evaluating the need for glasses or contact lenses for distance, intermediate, and near vision, as well as the frequency of use during daily activities. Higher levels of independence indicate better functional visual outcomes.
Time frame: 1 month, 3 months, and 6 months after surgery
Visual safety outcomes
Visual safety will be evaluated by changes in corrected distance visual acuity, including loss of one or more lines, loss of two or more lines, and calculation of the safety index.
Time frame: 1 week, 1 month, 3 months, and 6 months after surgery
Postoperative complications
Postoperative complications and adverse events will be recorded during follow-up, including corneal complications, inflammatory or infectious events and the need for additional treatment.
Time frame: From surgery to 6 months after surgery
Plan to share: No
Started May 2026 (actual). Primary completion is estimated for Jun 2028, 25 months after the start.
Of 42 non-industry interventional studies with no phase under Presbyopia, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 23. This study's planned 25 months is above that.
Counting every sponsor, half of 129 studies reached it within 10 months; a quarter within 3 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
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