PresbyopiaNCT07512089
Comparison of PRESBYOND Laser Blended Vision and Conventional Monovision LASIK in Individuals With Presbyopia: A Randomized Clinical Study
A study testing Laser Blended Vision LASIK and Traditional Monovision LASIK in people with Presbyopia and Refractive Error, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Presbyopia, Refractive Error
- What is being tested?
- Laser Blended Vision LASIK and Traditional Monovision LASIK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2026to 30 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060
Guofu Huang, +86-20-66686748, huangguofu@gzzoc.com
About this study
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:
Read more
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
Read the 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.
- Conditions
- Presbyopia, Refractive Error
- Being tested
- Laser Blended Vision LASIK, Traditional Monovision LASIK
- Keywords
- Presbyopia, LASIK, Laser Blended Vision, Monovision, Refractive Surgery, Randomized Clinical Trial
- Medical subject headings
- Presbyopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Blended Vision LASIKProcedure or surgery
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.
Traditional Monovision LASIKProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Laser Blended Vision LASIK | Experimental | 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. Receives: Procedure: Laser Blended Vision LASIK |
| Traditional Monovision LASIK | Active comparator | 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. Receives: Procedure: Traditional Monovision LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgery
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From surgery to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start12 May 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512089
- Sponsor's protocol ID
- IIT2025191
- Other IDs
- 2026KYPJ018
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waring GO 4th, Price FW Jr, Wirta D, McCabe C, Moshirfar M, Guo Q, Gore A, Liu H, Safyan E, Robinson MR. Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2022 Apr 1;140(4):363-371. doi: 10.1001/jamaophthalmol.2022.0059.
PubMed 35238902Hernandez-Lucena J, Alonso-Aliste F, Amian-Cordero J, Sanchez-Gonzalez JM. Outcomes of Corneal Compound Hyperopic Astigmatism With Presbyopia by Zeiss PRESBYOND Laser Blended Vision LASIK Using Default Custom Refractive Software Master Target Refractions for Reduced Anisometropia. J Refract Surg. 2024 Jul;40(7):e480-e489. doi: 10.3928/1081597X-20240506-02. Epub 2024 Jul 1.
PubMed 39007817Russo A, Reinstein DZ, Filini O, Archer TJ, Boldini A, Cardin G, Festa G, Morescalchi F, Salvalai C, Semeraro F. Visual and Refractive Outcomes Following Laser Blended Vision With Non-linear Aspheric Micro-anisometropia (PRESBYOND) in Myopic and Hyperopic Patients. J Refract Surg. 2022 May;38(5):288-297. doi: 10.3928/1081597X-20220323-01. Epub 2022 May 1.
PubMed 35536710Reinstein DZ, Ivory E, Chorley A, Archer TJ, Vida RS, Gupta R, Lewis T, Carp GI, Fonseca A, Parbhoo M. PRESBYOND Laser Blended Vision LASIK in Commercial and Military Pilots Requiring Class 1 Medical Certification. J Refract Surg. 2023 Jan;39(1):6-14. doi: 10.3928/1081597X-20221129-02. Epub 2023 Jan 1.
PubMed 36630432Ganesh S, Sriganesh SS. Laser refractive correction of presbyopia. Indian J Ophthalmol. 2024 Sep 1;72(9):1236-1243. doi: 10.4103/IJO.IJO_3074_23. Epub 2024 Aug 23.
PubMed 39185826Van Heerden A, Bigirimana D. Visual and Refractive Outcomes After Laser Blended Vision (PRESBYOND) in Patients With Myopia and Hyperopia. J Refract Surg. 2025 Oct;41(10):e1089-e1097. doi: 10.3928/1081597X-20250805-04. Epub 2025 Oct 1.
PubMed 41065739