A Study to Compare Visual Outcomes of Enhanced Monofocal IOLs vs Monofocal IOLs in the Pediatric Age Group
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AIIMS
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of children achieving binocular Unaided Near Vision N8 (0.4 logMAR) or better
研究概览
简要总结
Visual rehabilitation for near is important for children undergoing cataract surgery due to increased demands for near work. The compliance for glasses and post-operative follow-ups in children is generally sub-optimal in developing countries. Multifocal IOLs are a good option for rehabilitation of unaided near vision, however they are associated with post-operative glare, halos and dysphotopisa and may not be suitable for eyes which may potentially grow in axial length. Enhanced monofocal IOLs may potentially provide better binocular uncorrected near to intermediate visual acuity due to their extended range of focus as compared to standard monofocal IOLs with comparable photic phenomenon. This trial aims to study the optical performance of enhanced monofocal IOL versus standard monofocal IOL in pediatric age group with respect to binocular uncorrected near visual acuity. Secondarily, this trial will also compare the uncorrected and best-corrected distance and intermediate visual acuity, subjective refraction and acceptance, HOA, stereopsis (distance and near) and contrast sensitivity, need for near aid between the two groups.
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
- 6.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Bilateral developmental cataract with lens opacity obscuring red reflex and visual acuity less than 20/40 (0.3 logMAR) Axial Length between 21-25 mm Keratometry between 41-46D with no signs of ectasia Horizontal WTW between 10.5-12 mm Parents willing to enroll in the study and follow up.
排除标准
- •Near VA better than N8 (0.4 logMAR) Presence of concomittant ocular pathogies like allergic conjunctivitis, nystagmus, microcornea, corneal ectasia, keratitis, corneal opacities, total cataract,partially absorbed cataract, microspherophakia, lens subluxation or dislocation, glaucoma, optic atrophy, uveitis and retinal detachment.
- •Cases with history of trauma.
- •Systemic disorders like intellectual disability, congenital rubella syndrome and Down’s syndrome.
- •Parents unwilling to enroll in study and follow up.
结局指标
主要结局
Percentage of children achieving binocular Unaided Near Vision N8 (0.4 logMAR) or better
时间窗: 1 month, 6 month, 12 months after intervention
次要结局
- Comparison of visual outcomes in both groups with respect to post operative UDVA, CDVA, UIVA and CIVA at 66cm, Subjection Refraction and Acceptance, Percentage of eyes with 0.5D of Target, Stereopsis, Contrast Sensitivity, Internal Higher Order Aberrations, Need for Near Aid
研究者
Devashree Moktan
All India Institute of Medical Sciences