Multifocal Intraocular Lens vs. Monovision vs. Hybrid Monovision After Bilateral Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
To compare refractive outcomes and patient's visual quality after bilateral cataract surgery when implanting multifocal intraocular lens, monofocal with monovision or hybrid monovision.
详细描述
The purpose of this study is to evaluate the results in randomized patients that receive bilateral multifocal IOLs, monofocal IOLs with monovision with emmetropia in one eye and 1.50 D of myopia in the other eye, or monofocal IOL in the dominant eye and multifocal IOL in the non-dominant eye, then evaluate visual and refractive outcomes, as well as independence for glasses after bilateral surgery with 1 year of follow up.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bilateral senile cataracts.
- •Implantation of IOL in the capsular bag;
- •Implants from 10-30 diopter;
- •Potential Visual Acuity in ≥ 0.2 logMAR (20/32, metric scale) after surgery;
排除标准
- •Amblyopia;
- •Single Eye;
- •History of intraocular surgery in the previous year;
- •Sequel to prior ocular trauma;
- •Important Microphthalmia or aniridia;
- •History of damage to the corneal endothelium (chemical burns, herpetic keratitis, corneal guttata);
- •Corneal astigmatism > 1.0 D;
- •IOP ≥ 21 mmHg in standard caliper;
- •Ocular pathology that affects visual function (uveitis, diabetic retinopathy, age-related macular degeneration, macular dystrophy, retinal detachment, glaucoma, optic neuropathy);
- •Pupil > 5 mm or < 2 mm under photopic conditions;
- •Asymmetrical pupils in the eye or between the eyes;
- •Binocular vision absence;
- •Any situation that endangers the implant position in the capsular bag (post-traumatic zonular weakness, pseudoexfoliation, for example);
- •Patient probably need to laser treatment of the retina;
- •Patients whose expectations are unrealistic;
- •Patients whose lifestyle involves high expectations of visual acuity (writer, driver, for example);
- •Patients at risk of not meeting the clinical follow-up requirements (distance of travel difficulties, for example);
结局指标
主要结局
Visual acuity
时间窗: 1 year
Binocular visual acuity in a semi-darkened room without correction to far, intermediate and near using a typical Snellen chart that is frequently used for visual acuity testing.
次要结局
- Near stereopsis measure(1 year)
- National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) questionnaire(1 year)
- Contrast sensitivity measure(1 year)
- Speed reading measure(1 year)
研究者
Joao Crispim
Post graduated
Federal University of São Paulo