NCT07512089

Brief 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. 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
May 2026Jun 2028

First Submitted

Initial submission to the registry

March 19, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 6, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 12, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

July 7, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

March 19, 2026

Last Update Submit

July 5, 2026

Conditions

PresbyopiaRefractive Error

Keywords

PresbyopiaLASIKLaser Blended VisionMonovisionRefractive SurgeryRandomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months after surgery

Secondary Outcomes (10)

  • Binocular uncorrected visual acuity

    1 week, 1 month, 3 months, and 6 months after surgery

  • Refractive accuracy after surgery

    1 week, 1 month, 3 months, and 6 months after surgery

  • Refractive stability over time

    Up to 6 months after surgery

  • Contrast sensitivity

    1 week, 1 month, 3 months, and 6 months after surgery

  • Stereoacuity

    1 week, 1 month, 3 months, and 6 months after surgery

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Procedure: Traditional Monovision LASIK

Interventions

Traditional Monovision LASIKPROCEDURE

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.

Traditional Monovision LASIK
Laser Blended Vision LASIKPROCEDURE

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.

Laser Blended Vision LASIK

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 35238902BACKGROUND

  • Hernandez-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.

    PMID: 39007817BACKGROUND

  • Russo 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.

    PMID: 35536710BACKGROUND

  • Reinstein 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.

    PMID: 36630432BACKGROUND

  • Ganesh 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.

    PMID: 39185826BACKGROUND

  • Van 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.

    PMID: 41065739BACKGROUND

MeSH Terms

Conditions

PresbyopiaRefractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2026

First Posted

April 6, 2026

Study Start

May 12, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

July 7, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)