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临床试验/CTRI/2025/10/095785
CTRI/2025/10/095785尚未招募不适用

Comparative study of pre operative and post operative Astigmatism outcome following Simultaneous Pterygium and Small Incision Cataract Surgery (SICS)

DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
88
试验地点
1
主要终点
Primary Outcome:

研究概览

简要总结

Prospective comparative study to evaluate outcomes of simultaneous pterygium excision with small incision cataract surgery (SICS).

Eighty-eight patients with visually significant cataract and grade 1–2 pterygium will be included.

Preoperative evaluation: visual acuity, refraction, keratometry, axial length, intraocular pressure.

Surgery: SICS with pterygium excision under peribulbar anesthesia.

Follow-up: Day 1, Day 15, Day 30.

Primary outcome: change in type and degree of corneal astigmatism.

Secondary outcomes: correlation of pterygium size with astigmatism, improvement in uncorrected and best corrected visual acuity, patient satisfaction, intra- and postoperative complications.

The study will assess refractive stability and visual results of simultaneous surgery to guide clinical decision making.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
35.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients above 35 years of age 2) Male/Female 3) Patients diagnosed with visually significant cataract & pterygium 4) Patients with grade 1 and grade 2 pterygium 5) Patients with follow up of minimum 1month.
  • Participants who will give the informed consent.

排除标准

  • Patients with grade 3, 4 pterygium, any grade of recurrent pterygium, double headed pterygium and temporal pterygium.
  • Patients with traumatic cataract, developmental cataract, congenital cataract, past refractive surgeries.
  • Pre-existing diseases such as ocular diseases such as glaucoma or iridocyclitis, ocular pathologies, retinal pathologies, pre existing opacities and corneal degeneration 4) Non dilating pupil.

结局指标

主要结局

Primary Outcome:

时间窗: Baseline(Preoperative), post operative day 1, day 15 and day 30

Change in type and amount of corneal astigmatism

时间窗: Baseline(Preoperative), post operative day 1, day 15 and day 30

次要结局

  • Secondary Outcomes(1. Correlation between size/extent of pterygium and pre-operative astigmatism)

研究者

发起方
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DR AKSHAYA TANDLE

DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH

研究点 (1)

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