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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00986076

Enrollment

Registered

2009-09-29

Start date

2008-03-31

Completion date

2009-09-30

Last updated

2009-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Keywords

Pediatric Cataract Surgery, Low-Molecular weight Heparin, Intraocular infusion, Anti-inflammatory effect

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

Interventions

DRUGEnoxaparin

Enoxaparin 40 mg / 500 ml in Balanced Salt Solution

DRUGBalanced Salt Solution

Intraocular infusion of Balanced Salt solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 15 Years

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

Design outcomes

Primary

Measure	Time frame
Anterior Segment Inflammation	1 week

Secondary

Measure	Time frame
Anterior Segment inflammation	1 month, 3 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026