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

Study Overview
=================
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

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

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Drug: Enoxaparin
* Drug: Balanced Salt Solution


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enoxaparin infusion<br>Congenital Cataract Surgery with IOL implantation Intraocular infusion of Enoxaparin | Drug: Enoxaparin<br>* Enoxaparin 40 mg / 500 ml in Balanced Salt Solution<br>* Other names: Clexane(Aventis);|
| Placebo Comparator: Balanced Salt Solution Infusion<br>Congenital Cataract Surgery with IOL implantation Intraocular infusion of Balanced Salt Solution | Drug: Balanced Salt Solution<br>* Intraocular infusion of Balanced Salt solution<br>* Other names: BSS;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Segment Inflammation |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Segment inflammation |  | 1 month, 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric Cataract Surgery, Low-Molecular weight Heparin, Intraocular infusion, Anti-inflammatory effect