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

NCT07168109 | Not Yet Recruiting

• 1 other identifier: 2025KYPJ072
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract; High Myopia

Keywords

high myopia; cataract; impaired visual acuity

Outcome Measures

Primary Outcomes (1)

• Binocular uncorrected distance visual acuity at 4 m

  measured by the ETDRS chart

  3 months (±2 weeks) following the second eye surgery

Secondary Outcomes (8)

• Monocular and binocular uncorrected distance visual acuity at 4 m

  1, 6, 12 months following the second eye surgery

• Monocular and binocular uncorrected intermediate visual acuity at 80cm and 60cm

  1, 3, 6, 12 months following the second eye surgery

• Monocular and binocular uncorrected near visual acuity at 40cm

  1, 3, 6, 12 months following the second eye surgery

• Monocular and binocular defocus curves

  3, 6, 12 months following the second eye surgery

• Stereoscopic vision

  3, 6, 12 months following the second eye surgery

Other Outcomes (4)

• Binocular contrast sensitivity

  3, 6, 12 months following the second eye surgery

• Reading ability

  3, 6, 12 months following the second eye surgery

• Intraoperative or postoperative complications

  1, 3, 6, 12 months following the second eye surgery

Study Arms (2)

Monovision group

EXPERIMENTAL

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.

Procedure: Enhanced monofocal intraocular lens implantation (monovision strategy)

Bilateral myopia group

ACTIVE COMPARATOR

Both eyes will be implanted with enhanced monofocal intraocular lenses, with each eye targeted for -2.0 D.

Procedure: Enhanced monofocal intraocular lens implantation (bilateral myopia strategy)

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 \[Emmetropia Verifying Optical (EVO) version 2.0, Kane, LISA\].

Monovision group

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 \[Emmetropia Verifying Optical (EVO) version 2.0, Kane, LISA\].

Bilateral myopia group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead
• Shenzhen Eye Hospital: collaborator

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Lixia Luo

CONTACT

+8618665666679; luolixia@mail.sysu.edu.cn

Danyue Chen

CONTACT

+8615989073809; chendy68@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 11, 2025
• Study Start: October 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-08