Primary iris claw intraocular lens fixation versus secondary iris claw Intraocular lens fixation for visual outcome after posterior capsular rupture: A Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- 1.Best Corrected Visual Acuity(BCVA)
研究概览
简要总结
Cataract surgeries are one of the most common ocular surgeries, in which some complications are bound to happen. One among them being posterior capsular rupture in which patients may remain aphakic in many cases.
Thus, with the introduction of iris claw lenses, these patients gained BCVA of 6/18 or better according to previous studies conducted.
iris claw lenses can be placed retropupillary in the non reacting zone of the pupil.
In this study, we will be comparing iris claw lenses implantation within the primary sitting or if done after 6 weeks, for vision, IOP and pupil shape.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All cataract surgeries complicated due to Posterior Capsular Rupture (PCR) 2.All aphakic patients with no capsular support and patients with Posterior Capsular Rupture (PCR) who have undergone Cataract Surgery, where Posterior Chamber Intra Ocular Lens implantation is not possible.
排除标准
- •1.Patients with no perception of light and defective projection of rays (PR).
- •2.Significant iris pathology (iris atrophy, iris cyst, aniridia).
- •4.Chronic or recurrent uveitis/ iritis.
- •5.Diagnosed case of systemic hypertension with signs of retinopathy.
- •6.Severe diabetic eye disease.
- •7.Corneal pathology: Corneal scarring, irregularities or opacities.
结局指标
主要结局
1.Best Corrected Visual Acuity(BCVA)
时间窗: 1.Best Corrected Visual Acuity(BCVA) on day1 wk1 month1 | 2. IOP day1 wk1 followed by weekly readings if raised | 3.Pupil Shape day1 wk1 month1
2. IOP
时间窗: 1.Best Corrected Visual Acuity(BCVA) on day1 wk1 month1 | 2. IOP day1 wk1 followed by weekly readings if raised | 3.Pupil Shape day1 wk1 month1
3.Pupil Shape
时间窗: 1.Best Corrected Visual Acuity(BCVA) on day1 wk1 month1 | 2. IOP day1 wk1 followed by weekly readings if raised | 3.Pupil Shape day1 wk1 month1
次要结局
- 1.Hyphema(2. AC cells)
研究者
Dr Tahir Husain Ansari
Rohilkhand Medical College and Hospital