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

Overview

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.

Interventions

• Procedure Enhanced monofocal intraocular lens implantation (monovision strategy)
  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 de
• Procedure Enhanced monofocal intraocular lens implantation (bilateral myopia strategy)
  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

Primary outcome measures

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

Secondary outcome measures (8)

• Monocular and binocular uncorrected distance visual acuity at 4 m [Time frame: 1, 6, 12 months following the second eye surgery]
• Monocular and binocular uncorrected intermediate visual acuity at 80cm and 60cm [Time frame: 1, 3, 6, 12 months following the second eye surgery]
• Monocular and binocular uncorrected near visual acuity at 40cm [Time frame: 1, 3, 6, 12 months following the second eye surgery]
• Monocular and binocular defocus curves [Time frame: 3, 6, 12 months following the second eye surgery]
• Stereoscopic vision [Time frame: 3, 6, 12 months following the second eye surgery]
• Patient-reported outcome measures (PROMs): Vision-specific quality of life [Time frame: 3, 6, 12 months following the second eye surgery]
• Patient-reported outcome measures (PROMs): Photic phenomena [Time frame: 3, 6, 12 months following the second eye surgery]
• Patient-reported outcome measures (PROMs): Spectacle independence [Time frame: 3, 6, 12 months following the second eye surgery]

Eligibility criteria

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.

Exclusion criteria

• Poor-quality preoperative ocular biometry (Axial length, keratometry, anterior chamber depth);
• Preoperative corneal astigmatism ≥ 1.5 diopters (D);
• 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.);
• A history of intraocular surgery;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07168109 · 2025KYPJ072

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗