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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986076
• Other study ID #: 08-010
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2009
• Last updated: September 28, 2009
• Start date: March 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Iladevi Cataract and IOL Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cataract
• Inflammation

Intervention

Drug:
• Enoxaparin
Enoxaparin 40 mg / 500 ml in Balanced Salt Solution
• Balanced Salt Solution
Intraocular infusion of Balanced Salt solution

Locations

Country	Name	City	State
India	Iladevi Cataract & IOL Research Centre	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Iladevi Cataract and IOL Research Center

Country where clinical trial is conducted

India, 

References & Publications (3)

Kruger A, Amon M, Abela-Formanek C, Schild G, Kolodjaschna J, Schauersberger J. Effect of heparin in the irrigation solution on postoperative inflammation and cellular reaction on the intraocular lens surface. J Cataract Refract Surg. 2002 Jan;28(1):87-92. — View Citation

Rumelt S, Stolovich C, Segal ZI, Rehany U. Intraoperative enoxaparin minimizes inflammatory reaction after pediatric cataract surgery. Am J Ophthalmol. 2006 Mar;141(3):433-7. — View Citation

Wilson ME Jr, Trivedi RH. Low molecular-weight heparin in the intraocular irrigating solution in pediatric cataract and intraocular lens surgery. Am J Ophthalmol. 2006 Mar;141(3):537-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior Segment Inflammation		1 week	No
Secondary	Anterior Segment inflammation		1 month, 3 months	No