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

NCT ID: NCT07168109

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-07-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Enhanced monofocal intraocular lens implantation (monovision strategy)

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

Bilateral myopia group

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

Group Type: ACTIVE_COMPARATOR

Enhanced monofocal intraocular lens implantation (bilateral myopia strategy)

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

Interventions

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 determined preoperatively using the "finger method" . Intraocular lens power will be calculated using multiple formulas \[Emmetropia Verifying Optical (EVO) version 2.0, Kane, LISA\].

Intervention Type: 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 method". Intraocular lens power will be calculated using multiple formulas \[Emmetropia Verifying Optical (EVO) version 2.0, Kane, LISA\].

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Eye Hospital

OTHER

Sponsor Role: collaborator

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Lixia Luo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Lixia Luo

Role: CONTACT

luolixia@mail.sysu.edu.cn

+8618665666679

Danyue Chen

Role: CONTACT

chendy68@mail2.sysu.edu.cn

+8615989073809

Other Identifiers

2025KYPJ072

Identifier Type: -

Identifier Source: org_study_id