CTRI/2026/03/106488尚未招募不适用
A Prospective, Randomized, Comparative, Post-marketing clinical study to assess and compare the clinical outcomes and patient satisfaction of two Intraocular Lenses - pentafocal and trifocal IOLs following bilateral implantation.
未提供1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年5月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
The objectives of this study are to compare the binocular visual acuity for far, intermediate and near distance AND, to measure the Defocus Curve, Contrast Sensitivity & patient satisfaction among patients undergoing binocular cataract with pentafocal or trifocal Intraocular Lenses implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 year or greater
- •Patients with bilateral age related cataracts, require bilateral cataract phacoemulsification combined Intraocular Lens implantation;
- •Patients with axial length of
- •Normal corneas with less than 1.00 D of regular corneal astigmatism
- •Post-operative best corrected visual acuity projected to be 0.3 log MAR or lower
- •Fundus visualization is possible
- •Absence of retinal or optic nerve diseases.
排除标准
- •Previous intraocular or corneal surgery that may affect refraction accuracy or visual acuity
- •Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens
- •History or evidence of any ocular disease that may affect visual acuity
- •Rubella cataract
- •Amblyopia
- •Any other ocular condition that may predispose a subject to future complications or contraindicate implantation of the Intensity SL lens
- •Pupil abnormalities
- •Patients with pupil diameter greater than 4 mm in photopic conditions
- •Pregnant, lactating, or planning to become pregnant during the course of the trial
- •Allergy or intolerance to required study medications
- •Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days
- •Traumatic cataract
- •Irregular astigmatism
- •Instability of keratometry or biometry measurements
- •Patients receiving chloroquine treatment
- •Patient having Microphthalmia
- •Patient having Chronic Uveitis
- •Patient suffering from Corneal dystrophy or endothelial insufficiency.
- •Patient having active ocular diseases (active diabetic retinopathy, uncontrolled glaucoma).
研究者
Dr Lional Raj D
Dr. Agarwals Eye Hospital
研究点 (1)
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