Visual Outcomes of an Enhanced Monofocal Intraocular Lens Targeted for Monovision in Highly Myopic Eyes: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Binocular uncorrected distance visual acuity at 4 m
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Enhanced monofocal intraocular lens implantation (monovision strategy) (Procedure)
Bilateral myopia group
Both eyes will be implanted with enhanced monofocal intraocular lenses, with each eye targeted for -2.0 D.
干预措施: Enhanced monofocal intraocular lens implantation (bilateral myopia strategy) (Procedure)
结局指标
主要结局
Binocular uncorrected distance visual acuity at 4 m
时间窗: 3 months (±2 weeks) following the second eye surgery
measured by the ETDRS chart
次要结局
- 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)
- Patient-reported outcome measures (PROMs): Vision-specific quality of life(3, 6, 12 months following the second eye surgery)
- Patient-reported outcome measures (PROMs): Photic phenomena(3, 6, 12 months following the second eye surgery)
- Patient-reported outcome measures (PROMs): Spectacle independence(3, 6, 12 months following the second eye surgery)
- 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)
- Patient-reported outcome measures (PROMs): Vision-specific quality of life(3, 6, 12 months following the second eye surgery)
- Patient-reported outcome measures (PROMs): Photic phenomena(3, 6, 12 months following the second eye surgery)
- Patient-reported outcome measures (PROMs): Spectacle independence(3, 6, 12 months following the second eye surgery)
研究者
Lixia Luo
Professor
Zhongshan Ophthalmic Center, Sun Yat-sen University