Clinical Trial

Visual Outcomes of an Enhanced Monofocal Intraocular Lens Targeted for Monovision in Highly Myopic Eyes: a Randomized Controlled Trial

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Record status
This record was last updated September 18, 2025 (before its estimated April 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-03.
Trial Details
NCT Number NCT07168109
Lead Sponsor Zhongshan Ophthalmic Center, Sun Yat-sen University
Collaborators: Shenzhen Eye Hospital
Conditions Cataract, High Myopia
Enrollment 66 participants
Start Date 2025-10-01
Primary Completion 2026-04-01 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-18