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

Iladevi Cataract and IOL Research Center

Status and phase: Completed; Phase 4

Conditions: Inflammation

Treatments: Drug: Balanced Salt Solution; Drug: Enoxaparin

Study type: Interventional

Funder types: Other

Identifiers

NCT00986076

08-010

Details and patient eligibility

About

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.

Full 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

Enrollment: 23 patients

Sex: All

Ages: Under 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

23 participants in 2 patient groups, including a placebo group

Enoxaparin infusion

Experimental group

Description:

Congenital Cataract Surgery with IOL implantation Intraocular infusion of Enoxaparin

Treatment:

Drug: Enoxaparin

Balanced Salt Solution Infusion

Placebo Comparator group

Description:

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

Treatment:

Drug: Balanced Salt Solution