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

Not Applicable

Not yet recruiting

• Conditions: Cataract; High Myopia

• Registration Number: NCT07168109
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-03
• Study First Posted: 2025-09-11
• Last Update Submitted: 2025-09-11
• Last Update Posted: 2025-09-18
• Study Start: 2025-10-01
• Primary Completion: 2026-04-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Age between 18 and 85 years (inclusive), no gender restrictions;
2. Scheduled to undergo bilateral phacoemulsification with intraocular lens implantation;
3. Axial length ≥ 26.0 mm in both eyes;
4. Desire for postoperative spectacle independence;
5. Able to understand and cooperate with the trial procedures, voluntarily participate in this clinical trial, and sign an informed consent form.

Exclusion Criteria

1. Poor-quality preoperative ocular biometry (Axial length, keratometry, anterior chamber depth);
2. Preoperative corneal astigmatism ≥ 1.5 diopters (D);
3. Patients with intraoperative or postoperative complications (ie, intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, etc.);
4. The presence of other ocular diseases (ie, strabismus, severe retinal pathology, uveitis, other relevant ophthalmic diseases that might affect outcomes or trauma, etc.);
5. A history of intraocular surgery;
6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Binocular uncorrected distance visual acuity at 4 m	3 months (±2 weeks) following the second eye surgery	measured by the ETDRS chart

Secondary Outcome Measures

Name	Time	Method
Monocular and binocular uncorrected distance visual acuity at 4 m	1, 6, 12 months following the second eye surgery	measured by the ETDRS chart
Monocular and binocular uncorrected intermediate visual acuity at 80cm and 60cm	1, 3, 6, 12 months following the second eye surgery	measured by the EDTRS chart
Monocular and binocular uncorrected near visual acuity at 40cm	1, 3, 6, 12 months following the second eye surgery	measured by the EDTRS chart
Monocular and binocular defocus curves	3, 6, 12 months following the second eye surgery	measured by the binoptometer 4P
Stereoscopic vision	3, 6, 12 months following the second eye surgery
Patient-reported outcome measures (PROMs): Vision-specific quality of life	3, 6, 12 months following the second eye surgery	Vision-specific quality of life is measured by the Chinese version of the 9-item short-form of the Catquest questionnaire (Catquest-9SF). There are five text response options for the answers, scaled from "Yes, very great difficulties" to "No, no difficulties", including the answer "Cannot decide". The minimum score is 9, and the maximum score is 36.
Patient-reported outcome measures (PROMs): Photic phenomena	3, 6, 12 months following the second eye surgery	Pictures from the Quality of Vision (QoV) questionnaire were shown to patients, who were then asked to rate the frequency (never, occasionally, quite often, very often), severity (none, mild, moderate, severe) of photic phenomena and the extent to which these phenomena interfered with daily life (not at all, a little, quite, very).
Patient-reported outcome measures (PROMs): Spectacle independence	3, 6, 12 months following the second eye surgery	Spectacle independence is measured by a self-made spectacle independence questionnaire. Patients will be asked about the frequency of spectacle independence at the distance, intermediate, and near distances. There are three text response options for the answers, including "Always", "Seldom", and "Never".