A prospective, single centre, observational study on the visual performance of an enhanced monofocal IOL post phaco-emulsification cataract surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To evaluate visual and refractive outcomes, as well as patient satisfaction after bilateral implantation of an enhanced monofocal intraocular lens (Eyhance IOL - Johnson and Johnson vision) with emmetropia as a target refraction.
研究概览
简要总结
This prospective observational study evaluates the real-world visual performance of enhanced monofocal intraocular lenses (IOLs), specifically the Johnson & Johnson Vision Eyhance lens, implanted bilaterally after uncomplicated phacoemulsification. Beyond standard visual acuity testing for distance, intermediate, and near vision, the study assesses advanced parameters such as pupillometry (under mesopic and photopic conditions), contrast sensitivity, and defocus curves under uniocular and binocular settings. Patient-reported outcomes will be captured using the validated Catquest-9SF questionnaire. The goal is to provide a comprehensive understanding of visual quality and functionality with enhanced monofocal IOLs to inform better patient selection and counseling in cataract surgery.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Undergone bilateral implantation with Johnson and Johnson Tecnis Eyhance enhanced monofocal IOL.
- •Willingness to undergo minimum follow up period of 1 month after second eye cataract surgery.
- •Pre Op corneal astigmatism less than/equal to 0.75D.
排除标准
- •Age 20-80 Years except cataract History of trauma or previous ocular surgery.
- •Axial length over 25mm Pre-existing corneal pathology.
- •Glaucoma or optic neuropathy.
- •Diabetic retinopathy or macular degeneration.
- •• Systemic conditions affecting neuro-ocular pathways.
- •• Intra-operative complications (e.g. posterior capsular rupture, IOL outside the bag).
结局指标
主要结局
To evaluate visual and refractive outcomes, as well as patient satisfaction after bilateral implantation of an enhanced monofocal intraocular lens (Eyhance IOL - Johnson and Johnson vision) with emmetropia as a target refraction.
时间窗: Day1, Day7, Day15, 1 Month.
次要结局
- To compare visual outcomes with preoperative parameters and with established data from conventional monofocal IOLs.(To assess the extent of spectacle independence achieved by the patients for various visual functions and activities of daily living using Catquest-9SF questionnaire.)
研究者
Shubham Vivek Naik
Bhaktivedanta Hospital and research institute