A Comparative Study of B-HEX pupil expander versus Malyugin ring in Management of Cataracts with Small Pupils
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To compare the post-operative iris distortion rate after Cataract surgeries with small pupils performed with B-HEX pupil expander versus Malyugin ring
研究概览
简要总结
A total of 64 patients of Cataract with non-dilating pupils presenting to the Ophthalmology OPD of this tertiary care hospital would be included in the study after securing necessary informed consent. Detailed ophthalmic evaluation of the selected subjects would be performed including best corrected visual acuity, anterior segment evaluation by slit lamp biomicroscopy, grade of cataract and posterior segment evaluation and USG B scan in case of hazy fundus view. These patients would then be sent for obtaining pre anaesthetic clearance The patients will then be randomised into two treatment arms using computerised random table. The surgery would be performed by experienced surgeons via clear corneal incision. Intra operatively B HEX pupil expander or Malyugin ring would be inserted to expand the pupil mechanically and rest of surgery would proceed as per convention. Foldable Intra ocular lens will be implanted. The operating time, ease of insertion, occurrence of intra operative complications like PCR, Zonular dialysis will be documented. Post-operative outcome measures like visual acuity, cosmetic appearance of pupil/pupil distortion, corneal oedema, macular oedema and inflammation will also be documented and compared between the two arms. Mean age at presentation was 70.5±10.12 years. Most common cause for small pupil was tamsulosin therapy. MR causes significantly more pupillary distortion in the postoperative period compared to B-Hex ring. Though, both the rings cause pupillary distortion, these devices expand the surgical area adequately, ease the procedure, decrease risk of complications and results in good functional visual outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients being worked up for Phaco emulsification with PCIOL implantation with pupils not dilating more than 4 mm.
排除标准
- •Patient requiring combined Corneal, glaucoma or retinal procedure and patients with pre-existing macular oedema, post uveitis irregular pupils.
结局指标
主要结局
To compare the post-operative iris distortion rate after Cataract surgeries with small pupils performed with B-HEX pupil expander versus Malyugin ring
时间窗: Post operative period
次要结局
- To compare the post-operative iris distortion rate after Cataract surgeries with small pupils performed with B-HEX pupil expander versus Malyugin ring(Immediately and 1 month post operatively)
