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临床试验/NCT05457348
NCT05457348Unknown不适用

Effect of Single Incision Versus Three Planned Incision to Reduce Pre-operative Astigmatism After Phacoemulsification.

Suleman Roshan Medical College2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年7月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
160
试验地点
2
主要终点
Reduction in Astigmatism

研究概览

简要总结

Cataract surgery by phacoemulsification is the most commonly performed procedure in Pakistan. Cataract surgery aims for visual rehabilitation and freedom from all kinds of eyewear. Pre-operative corneal astigmatism greater than 1.0 Diopter is reported in 42% preoperatively and 58%postoperatively after implanting a monofocal intraocular lens(IOL). Visual acuity tended to worsen postoperatively with increased astigmatism4. Different treatment modalities are used to reduce astigmatism, like toric IOL. Limbal relaxing incision, actuate keratotomy, intrastromal rings, Lasik and femtosecond laser. Most of these modalities are expensive, so they cannot be afforded by the patients as Pakistan is a low-income country with a per capita income of US$1,562 (160th worldwide)

详细描述

According to the 2020 estimate, 33·6 million adults aged 50 years and older were blind with cataracts as a leading cause (15·2 million cases). According to Pakistan national blindness survey, cataract is the leading cause of blindness in Pakistan. Cataract surgery by phacoemulsification is the most commonly performed procedure in Pakistan. Cataract surgery aims for visual rehabilitation and freedom from all kinds of eyewear. Pre-operative corneal astigmatism greater than 1.0 Diopter is reported in 42% preoperatively and 58%postoperatively after implanting a mono-focal intraocular lens(IOL). Visual acuity tended to worsen postoperatively with increased astigmatism. Different treatment modalities are used to reduce astigmatism, like toric IOL. Limbal relaxing incision, actuate keratotomy, intrastromal rings, Lasik and femtosecond laser. Most of these modalities are expensive, so they cannot be afforded by the patients as Pakistan is a low-income country with a per capita income of US$1,562 (160th worldwide). Our study aims to compare the results of phacoemulsification cataract surgery with a planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian incisions ( group A) with convention supero-temporal 2.8 mm clear corneal incision(Group B) for the correction of postoperative astigmatism. We hypothesize that a planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian incisions ( group A) is better than conventional supero-temporal 2.8 mm clear corneal incision(Group B) for the correction of postoperative astigmatism at a significant level of 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The patient will be selected and randomized into two groups after obtaining informed consent. patient will not know about the intervention

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cataract patients aged between 50 and 80 years having 1.0 diopters (D) or greater of regular corneal astigmatism documented by keratometry.

排除标准

  • Previous ocular surgery.
  • previous ocular trauma.
  • Pre-existing ocular disease.
  • High intraocular pressure (IOP)
  • Corneal opacity.
  • Diabetes mellitus
  • Irregular astigmatism.

结局指标

主要结局

Reduction in Astigmatism

时间窗: Patients will be assessed at first postoperative day then after one month , three months and six months.

Postoperative reduction in astigmatism after phacoemulsification.

次要结局

未报告次要终点

研究者

发起方
Suleman Roshan Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamshad Ahmed

Professor

Suleman Roshan Medical College

研究点 (2)

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