Visual Outcomes of an Enhanced Monofocal Intraocular Lens Targeted for Monovision in Highly Myopi… (NCT07168109) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Visual Outcomes of an Enhanced Monofocal Intraocular Lens Targeted for Monovision in Highly Myopic Eyes: a Randomized Controlled Trial
66 participantsStarted 2025-10-01
Plain-language summary
The goal of this clinical trial is to evaluate whether an enhanced monofocal intraocular lens targeted for monovision can improve visual outcomes in patients with cataract and high myopia (axial length ≥ 26 mm).
The main questions it aims to answer are:
For people with cataract and high myopia, does an enhanced monofocal intraocular lens targeted for monovision provide greater binocular uncorrected distance visual acuity compared with targeting myopia in both eyes? Does an enhanced monofocal intraocular lens targeted for monovision provide comparable binocular uncorrected intermediate and near visual acuity, contrast sensitivity, reading ability, spectacle independence, stereopsis, and photic phenomena compared with targeting myopia in both eyes?
Researchers will compare an enhanced monofocal intraocular lens targeted for monovision with one targeted for myopia in both eyes to determine whether the monovision strategy is more effective.
Participants will:
Undergo phacoemulsification with enhanced monofocal intraocular lens implantation. Attend follow-up visits at 1, 3, 6, and 12 months after cataract surgery.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Age between 18 and 85 years (inclusive), no gender restrictions;
✓. Scheduled to undergo bilateral phacoemulsification with intraocular lens implantation;
✓. Axial length ≥ 26.0 mm in both eyes;
✓. Desire for postoperative spectacle independence;
✓. Able to understand and cooperate with the trial procedures, voluntarily participate in this clinical trial, and sign an informed consent form.
✕. Patients with intraoperative or postoperative complications (ie, intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, etc.);
✕. The presence of other ocular diseases (ie, strabismus, severe retinal pathology, uveitis, other relevant ophthalmic diseases that might affect outcomes or trauma, etc.);
What they're measuring
1
Binocular uncorrected distance visual acuity at 4 m
Timeframe: 3 months (±2 weeks) following the second eye surgery
Trial details
NCT IDNCT07168109
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
✕. Severe chronic systemic diseases, psychiatric disorders, dementia, hearing impairments, or mobility limitations that would interfere with understanding of the monovision design, attendance at follow-up visits, or completion of questionnaires.