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NCT Number: NCT07168109

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

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.

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Key information

Conditions

Cataract Eye Diseases High Myopia Lens Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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].

Primary outcomes

  1. Binocular uncorrected distance visual acuity at 4 m

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

    measured by the ETDRS chart

Secondary outcomes

  1. Monocular and binocular uncorrected distance visual acuity at 4 m

    Time frame: 1, 6, 12 months following the second eye surgery

    measured by the ETDRS chart

  2. Monocular and binocular uncorrected intermediate visual acuity at 80cm and 60cm

    Time frame: 1, 3, 6, 12 months following the second eye surgery

    measured by the EDTRS chart

  3. Monocular and binocular uncorrected near visual acuity at 40cm

    Time frame: 1, 3, 6, 12 months following the second eye surgery

    measured by the EDTRS chart

  4. Monocular and binocular defocus curves

    Time frame: 3, 6, 12 months following the second eye surgery

    measured by the binoptometer 4P

  5. Stereoscopic vision

    Time frame: 3, 6, 12 months following the second eye surgery

  6. Patient-reported outcome measures (PROMs): Vision-specific quality of life

    Time frame: 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.

  7. Patient-reported outcome measures (PROMs): Photic phenomena

    Time frame: 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).

  8. Patient-reported outcome measures (PROMs): Spectacle independence

    Time frame: 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".

Other outcomes

  1. Binocular contrast sensitivity

    Time frame: 3, 6, 12 months following the second eye surgery

  2. Reading ability

    Time frame: 3, 6, 12 months following the second eye surgery

    measured by the International Reading Speed Texts (IResT)

  3. Intraoperative or postoperative complications

    Time frame: 1, 3, 6, 12 months following the second eye surgery

    Clinical manifestations are assessed and recorded by the ophthalmologist.

  4. Self-reported incidence and severity of ocular discomfort

    Time frame: 1, 3, 6, 12 months following the second eye surgery

    collected by self-reported outcomes and past medical records (if any) of participants

Study contacts

Contact information is provided by the study sponsor or research team.

Danyue Chen

CONTACT

[email protected]

+8615989073809

Lixia Luo

CONTACT

[email protected]

+8618665666679

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Collaborators

  • Shenzhen Eye Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 11, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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