Comparison of PRESBYOND Laser Blended Vision and Conventional Monovision LASIK in Individuals With Presbyopia: A Randomized Clinical Study

March 31, 2026 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 40 to 55 years with presbyopia
  • Suitable candidates for LASIK surgery based on clinical evaluation
  • Stable refractive status for at least 1 year
  • Best corrected distance visual acuity within normal range
  • Willing and able to provide written informed consent
  • Willing to comply with study visits and follow-up

Exclusion Criteria:

  • Previous ocular surgery
  • Corneal disease or abnormal corneal condition that may affect safety
  • Significant ocular disease affecting visual function
  • Severe dry eye or other ocular surface disorders
  • Systemic disease that may affect study participation
  • Inability to tolerate monovision or anisometropia
  • Any condition that the investigator considers unsuitable for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser Blended Vision LASIK
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
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.
Active Comparator: Traditional Monovision 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving target binocular visual acuity at multiple distances
Time Frame: 6 months after surgery
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.
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binocular uncorrected visual acuity
Time Frame: 1 week, 1 month, 3 months, and 6 months after surgery
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.
1 week, 1 month, 3 months, and 6 months after surgery
Refractive accuracy after surgery
Time Frame: 1 week, 1 month, 3 months, and 6 months after surgery
Refractive accuracy will be evaluated using the difference between achieved and target refraction and the proportion of eyes within predefined refractive ranges.
1 week, 1 month, 3 months, and 6 months after surgery
Refractive stability over time
Time Frame: Up to 6 months after surgery
Refractive stability will be assessed by changes in spherical equivalent during follow-up visits.
Up to 6 months after surgery
Contrast sensitivity
Time Frame: 1 week, 1 month, 3 months, and 6 months after surgery
Contrast sensitivity will be measured using a standardized contrast sensitivity testing system (CSV-1000, VectorVision, USA) at multiple spatial frequencies.
1 week, 1 month, 3 months, and 6 months after surgery
Stereoacuity
Time Frame: 1 week, 1 month, 3 months, and 6 months after surgery
Stereoacuity will be measured using a standardized stereopsis test (Randot Stereo Test) at near distance to evaluate binocular visual function.
1 week, 1 month, 3 months, and 6 months after surgery
NEI Visual Function Questionnaire-25 (NEI VFQ-25)
Time Frame: 1 week, 1 month, 3 months, and 6 months after surgery
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.
1 week, 1 month, 3 months, and 6 months after surgery
Quality of Vision (QoV) questionnaire
Time Frame: 1 month, 3 months, and 6 months after surgery
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.
1 month, 3 months, and 6 months after surgery
Spectacle independence
Time Frame: 1 month, 3 months, and 6 months after surgery
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.
1 month, 3 months, and 6 months after surgery
Visual safety outcomes
Time Frame: 1 week, 1 month, 3 months, and 6 months after surgery
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.
1 week, 1 month, 3 months, and 6 months after surgery
Postoperative complications
Time Frame: From surgery to 6 months after surgery
Postoperative complications and adverse events will be recorded during follow-up, including corneal complications, inflammatory or infectious events and the need for additional treatment.
From surgery to 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2025191
  • 2026KYPJ018 (Other Identifier: Ethics committee of the Zhongshan Ophthalmic Center, Sun Yat-sen University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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