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临床试验/CTRI/2026/01/100383
CTRI/2026/01/100383尚未招募Unknown

ARCUATE KERATOTOMY VERSUS TORIC INTRAOCULAR LENS IMPLANTATION IN FEMTOSECOND LASER ASSISTED CATARACT SURGERY FOR LOW TO MODERATE CORNEAL ASTIGMATISM: A PROSPECTIVE RANDOMISED CONTROLLED TRIAL

Oo DGAFMS Ministry of Defence A Block Defence Offices Complex Africa Avenue New Delhi1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2026年1月17日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
206
试验地点
1

研究概览

简要总结

Both femtosecond laser arcuate keratotomy (FSAK) and toric intraocular lenses (TIOLs) are established techniques to correct corneal astigmatism during cataract surgery. With the advent of the ALLY Adaptive Cataract Treatment System, the precision and integration of FSAK have improved. This randomized controlled trial evaluates FSAK versus TIOLs for astigmatism correction. It is a  prospective, assessor-masked, randomized controlled trial at a tertiary care centre over 06 months. Patients with regular corneal astigmatism (1.0–2.0 D) and visually significant cataract will be randomized to either FSAK and monofocal IOL using ALLY, or  TIOL implantation using ALLY. Primary endpoint is residual refractive cylinder at 3 months. Secondary outcomes are uncorrected and bestcorrected distance visual acuity, vector analysis, rotational stability (TIOL), patient satisfaction, and adverse events.This trial will clarify whether ALLY assisted FSAK can achieve refractive outcomes comparable to TIOL implantation with potential workflow advantages.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Presence of visually significant cataract Pre-existing regular corneal astigmatism (1.0 D to 2.0 D) Clear corneal media.

排除标准

  • Irregular astigmatism Corneal pathology (scar, keratoconus, dystrophy) Previous ocular surgery or trauma Posterior segment pathology affecting vision.

研究者

发起方
Oo DGAFMS Ministry of Defence A Block Defence Offices Complex Africa Avenue New Delhi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dubbaka Srujana

Army Hospital (Research and Referral)

研究点 (1)

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