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

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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

Первичные конечные точки

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

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07168109 · 2025KYPJ072

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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