Trial | NCT00986076  Report issue

Title

Clinical Trial on Anti-inflammatory Effect of Low-Molecular Weight Heparin in Pediatric Cataract Surgery
Randomized Clinical Trial Evaluating Anti-inflammatory Effect of Low Molecular-Weight Heparin in Pediatric Cataract and Intraocular Lens Surgery

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    23
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.
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 Started
Mar 31
2008
Primary Completion
Apr 30
2009
Study Completion
Sep 30
2009
Last Update
Sep 29
2009
Estimate

Drug Enoxaparin

Enoxaparin 40 mg / 500 ml in Balanced Salt Solution

  • Other names: Clexane(Aventis)

Drug Balanced Salt Solution

Intraocular infusion of Balanced Salt solution

  • Other names: BSS

Enoxaparin infusion Experimental

Congenital Cataract Surgery with IOL implantation Intraocular infusion of Enoxaparin

Balanced Salt Solution Infusion Placebo Comparator

Congenital Cataract Surgery with IOL implantation Intraocular infusion of Balanced Salt Solution

Criteria 

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
No Results Posted