Clinical Trial on Anti-inflammatory Effect of Low-Molecular Weight Heparin in Pediatric Cataract Surgery

Phase 4

Completed

• Conditions: Inflammation
• Interventions: Drug: Balanced Salt Solution; Drug: Enoxaparin

• Registration Number: NCT00986076
• Lead Sponsor: Iladevi Cataract and IOL Research Center

Brief Summary

The purpose of this study is to determine if intraocular infusion of low-molecular weight heparin (enoxaparin) influences postoperative inflammation following pediatric cataract surgery with intraocular lens (IOL) implantation.

Detailed Description

Despite advances in cataract surgery in children, postoperative inflammation is a significant complication following pediatric cataract surgery. Any drug that prevents or decreases this inflammation would be beneficial.

Heparin has anti-inflammatory and antiproliferative effects as well as anticoagulant properties. Several studies on animal and adult human eyes show that adding heparin to the irrigating solution during cataract surgery results in less disturbance of the blood-aqueous barrier and helps prevent posterior capsule opacification (PCO).

A prospective, randomized, controlled and masked study is mandatory to evaluate the anti-inflammatory effect of Low-molecular weight Heparin for pediatric cataract surgery

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-04
• Status Verified: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2009-09-26
• Study First Submitted QC: 2009-09-28
• Last Update Submitted: 2009-09-28
• Study First Posted: 2009-09-29
• Last Update Posted: 2009-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Children (0-15 years) with congenital cataract scheduled for surgery with IOL implantation and informed consent from the parents/legal guardian

Exclusion Criteria

• Preoperative: Associated ocular anomalies (uveitis, microphthalmos, persistent fetal vasculature, aniridia, glaucoma, iris coloboma), traumatic cataract
• Intraoperative: Inability to implant IOL in the capsular bag, intraoperative complications- iris trauma, vitreous disturbance, descemet's detachment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balanced Salt Solution Infusion	Balanced Salt Solution	Congenital Cataract Surgery with IOL implantation Intraocular infusion of Balanced Salt Solution
Enoxaparin infusion	Enoxaparin	Congenital Cataract Surgery with IOL implantation Intraocular infusion of Enoxaparin

Primary Outcome Measures

Name	Time	Method
Anterior Segment Inflammation	1 week

Secondary Outcome Measures

Name	Time	Method
Anterior Segment inflammation	1 month, 3 months

Trial Locations

Locations (1)

Iladevi Cataract & IOL Research Centre; 🇮🇳 Ahmedabad, Gujarat, India