Assistant Lecturer of Ophthalmology Department, Sohag University
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- change of corneal astigmatism assessed by K readings measurment
研究概览
简要总结
The goal of this is prospective, computer based randomized clinical trial is to compare the efficacy of reduction of the pre-existing corneal astigmatism at the time of cataract surgery in patients admitted in sohag university hospital.
the main questions it aims to answer are :
- Is limbal relaxing incisions as effective as the paired opposite 4mm clear corneal incisions technique in reduction of corneal astigmatism at the time of cataract surgery ?
- Are both techniques effective in treating mild degrees of corneal Astigmatism ?
All participants will have full ophthalmological examination necessary for routine cataract surgery, then randomly divided into 2 groups, clear corneal incision group & limbal relaxing incision group.
Researcher will compare difference between both groups regarding the following :
- Uncorrected distance visual acuity (UCVA)
- Best Corrected visual acuity (BCVA)
- keratometry readings
详细描述
This is prospective clinical trial will be established in Sohag university hospital. All cataract patients who will be admitted and meet the study inclusion criteria will be enrolled in this study. Candidates will be computer based randomly divided into two groups, opposite clear corneal incisions group & limbal relaxing incision group.
Inclusion criteria:
- Cataract patients aged 21- 80 years.
- keratometric astigmatism 1Diopter - 4 Diopters.
- Healthy clear cornea.
Exclusion criteria:
- History of previous keratorefractive or anterior segment surgery.
- Previous ocular trauma .
- Corneal scar or opacities.
- Irregular corneal astigmatism.
- Cataract unsuitable for phacoemulsification.
- Ongoing chronic ocular pathology
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)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataract patients aged 21- 80 years.
- •keratometric astigmatism 1D - 4D.
- •Healthy clear cornea
排除标准
- •History of previous keratorefractive or anterior segment surgery.
- •Previous ocular trauma .
- •Corneal scar or opacities.
- •Irregular corneal astigmatism.
- •Cataract unsuitable for phacoemulsification.
- •Ongoing chronic ocular pathology
研究组 & 干预措施
Clear corneal incisions
the Steep meridian will be identified and marked, One clear corneal incision will be made on one side of the steep axis using 2.4mm keratome knife then enlarged to 4mm after completion of cataract surgery & other corneal 4mm incision is added to the other side of the steep axis
干预措施: surgical correction of astigmatism with cataract (Procedure)
Limbal relaxing incision
Single or paired LRI will be performed on the steep axis prior to phaco-emulsification procedure using a 600 μm diamond guarded blade.
干预措施: surgical correction of astigmatism with cataract (Procedure)
结局指标
主要结局
change of corneal astigmatism assessed by K readings measurment
时间窗: 1month post operative , 3 month post operative , 6 month post operative
keratometry readings by autokeratometry, Topcon KR-8900, Tokyo, Japan ) confirmed by Pentacam (Sirius Scheimpflug Placido topography .CSO, Florence, Italy).
次要结局
- change of manifest refraction assessed by autorefractometer (Topcon KR-8900, Tokyo,(1month post operative , 3 month post operative , 6 month post operative)
研究者
Yasmine Gamal Abdellatife
assistant lecturer of opthalmology
Sohag University