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临床试验/CTRI/2025/11/097990
CTRI/2025/11/097990尚未招募1/2 期

A Randomised Controlled Trial Comparing the Outcomes of Different Irrigation-Aspiration Techniques for Viscoelastic Removal in Cataract Surgery

SUNKARA VENKATA MAHALAKSHMI1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
126
试验地点
1
主要终点
Measurement of

研究概览

简要总结

Study Title

A Randomized Controlled Trial Comparing the Outcomes of Different Irrigation-Aspiration Techniques for Viscoelastic Removal in Cataract Surgery

Introduction

Ophthalmic viscoelastic devices (OVDs) are essential in cataract surgery to maintain anterior chamber depth, protect intraocular structures, and facilitate intraocular lens (IOL) implantation. Incomplete OVD removal, especially behind the IOL in the retrolental space, may cause postoperative complications like intraocular pressure (IOP) spikes, capsular block syndrome (CBS), and unintended refractive shifts.

Techniques Compared

  • *Technique A:* Aspiration from the anterior chamber with IOL tapping.

  • *Technique B:* Active aspiration behind the IOL using an irrigation and aspiration (IA) probe while maintaining capsular integrity.

Aim

To compare the efficiency and outcomes of these two IA techniques in OVD removal during phacoemulsification cataract surgery.

Study Design

  • Prospective, double-blinded, randomized controlled trial.

  • Total sample size: 126 patients (63 in each group).

  • Single experienced surgeon performing all surgeries under standardized conditions.

  • Follow-up at Day 1, Week 1, and Week 6 postoperatively.

  • Outcomes measured: IOP, IOL position (anterior segment imaging), spherical equivalent refractive outcomes, anterior chamber depth changes.

Inclusion Criteria

  • Age 50–80 years.

  • Nuclear sclerosis grade II–III (LOCS III classification).

  • Normal axial length 21.5–24.5 mm.

  • No prior ocular surgery.

  • Willingness to follow up.

Exclusion Criteria

  • Glaucoma or ocular hypertension.

  • Pseudoexfoliation syndrome or zonular instability.

  • Corneal dystrophies or opacities.

  • Poor pupil dilation <6 mm.

  • History of uveitis or ocular trauma.

  • Patients lost to follow-up.

Ethics

  • Institutional ethical approval obtained.

  • Adherence to Declaration of Helsinki.

  • Informed consent obtained from all participants.

This trial aims to provide evidence-based guidance on the best irrigation-aspiration technique to reduce postoperative complications and improve visual outcomes after cataract surgery

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
50.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Nuclear sclerosis grade II—III (Lens Opacities Classification System III) Normal axial length (21.5—24.5 mm) No prior ocular surgery Follow up patients.

排除标准

  • Patients lost to follow-up Patients with Glaucoma, Corneal opacity, or dystrophy History of uveitis, trauma Pseudo-exfoliation or zonular instability Patients with poor pupil dilation -less than 6mm.

结局指标

主要结局

Measurement of

时间窗: Day 1, Week 1, Week 6

1.Intraocular pressure (IOP),

时间窗: Day 1, Week 1, Week 6

2 Intraocular Lens Position (IOLP) using anterior segment imaging.

时间窗: Day 1, Week 1, Week 6

3.Refractive outcomes-the spherical equivalent (SE)

时间窗: Day 1, Week 1, Week 6

4.Anterior chamber (AC) depth changes over the first 6 weeks post-surgery between the two groups.

时间窗: Day 1, Week 1, Week 6

次要结局

未报告次要终点

研究者

发起方
SUNKARA VENKATA MAHALAKSHMI
申办方类型
Other [slef]
责任方
Principal Investigator
主要研究者

SUNKARA VENKATA MAHALAKSHMI

ALLURI SITARAMARAJU ACADEMY OF MEDICAL SCIENCES, ELURU

研究点 (1)

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