A comparative study of surgical outcome between iris claw and scleral tuck lens in primary cataract surgery by phacoemulsification in a tertiary care centre
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Iris-claw lenses may offer better stability and fewer complications. On the contrary, scleral tuck lenses provide comparable visual improvement.
研究概览
简要总结
The researchers here describe the comparison between the iris claw lens and the scleral tuck lens during primary cataract surgery by phacoemulsification. The current study will be conducted for 2 years in the tertiary rural care hospital, Wardha, which is a two-arm open-label randomised control trial that will include 66 patients in total (Group Iris claw lens and Group Scleral tuck lens). Before the patients undergo the intervention trial, the demographic and ophthalmological examination details (visual acuity, intraocular pressure, fundus examination, and biometric measurement) will be collected on the proforma, and after the surgery, the later data (intraoperative and postoperative complications, intraocular pressure, uncorrected and best-corrected visual acuity, lens-induced astigmatism, and patient satisfaction) will be collected on the EXCEL sheet, and the required statistical analysis will be done. Iris claw lenses may offer better stability and fewer complications, while scleral tuck lenses may provide comparable visual improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Aphakia resulting from current cataract surgery.
- •Patients who provide informed consent
- •IOL power calculation is performed by a single designated individual
- •Surgery performed by the same surgeon.
排除标准
- •Pre-existing corneal diseases like keratitis, corneal dystrophy, and corneal opacities.
- •History of recurrent uveitis or severe iris damage.
- •Retinal pathologies like diabetic and hypertensive retinopathy, retinitis pigmentosa, age-related macular degeneration, and maculopathy.
- •Cases of traumatic aphakia.
- •Patients with exaggerated glaucoma.
结局指标
主要结局
Iris-claw lenses may offer better stability and fewer complications. On the contrary, scleral tuck lenses provide comparable visual improvement.
时间窗: Assessment will be done on Day 1, Day 15, Day 30, and Day 90 post-operatively
次要结局
- Intraoperative and post-operative complications of iris claw lens and scleral tuck lens(Assessment will be done during surgery and Day 1, Day 15, Day 30, and Day 90 post-operatively)
研究者
Dr Mohammed Kaderi
Department of ophthalmology