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

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study ID
NCT07168109
Status
Not Yet Recruiting

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Conditions

  • Cataract
  • High Myopia

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Enhanced monofocal intraocular lens implantation (monovision strategy) — PROCEDURE
    Participants will undergo phacoemulsification with the implantation of an enhanced monofocal intraocular lens, targeting -0.5 D in the dominant eye and -2.0 D in the non-dominant eye. The first operated eye will be selected based on the worse corrected distance visual acuity; if both eyes are similar, the eye subjectively perceived by the patient as having worse vision will be chosen. The second eye surgery will be performed within 2 weeks after the first eye surgery. Ocular dominance will be determined preoperatively using the "finger method" . Intraocular lens power will be calculated using multiple formulas \[Emmetropia Verifying Optical (EVO) version 2.0, Kane, LISA\].
  • Enhanced monofocal intraocular lens implantation (bilateral myopia strategy) — PROCEDURE
    Participants will undergo phacoemulsification with the implantation of an enhanced monofocal intraocular lens, targeting -2.0 D in both eyes. The first operated eye will be selected based on the worse corrected distance visual acuity; if both eyes are similar, the eye subjectively perceived by the patient as having worse vision will be chosen. The second eye surgery will be performed within 2 weeks after the first eye surgery. Ocular dominance will be determined preoperatively using the "finger method". Intraocular lens power will be calculated using multiple formulas \[Emmetropia Verifying Optical (EVO) version 2.0, Kane, LISA\].

Study Details

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.

Key Dates

First listed
Sep 11, 2025
Start date
Oct 1, 2025
Status verified
Aug 2025
Primary completion
Apr 1, 2026
Completion
Jul 1, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Monovision group
    Both eyes will be implanted with enhanced monofocal intraocular lenses, with the dominant eye targeted for -0.5 diopters (D) and the nondominant eye for -2.0 D.
  • Active Comparator: Bilateral myopia group
    Both eyes will be implanted with enhanced monofocal intraocular lenses, with each eye targeted for -2.0 D.

Primary Outcome Measure

Binocular uncorrected distance visual acuity at 4 m [ Time Frame: 3 months (±2 weeks) following the second eye surgery ]

Central Contacts

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