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

Information source: Iladevi Cataract and IOL Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Inflammation

Intervention: Enoxaparin (Drug); Balanced Salt Solution (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Iladevi Cataract and IOL Research Center

Official(s) and/or principal investigator(s):
Viraj A Vasavada, MS, Principal Investigator, Affiliation: Iladevi Cataract & IOL Research Centre


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.

Clinical Details

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

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

Primary outcome: Anterior Segment Inflammation

Secondary outcome: Anterior Segment inflammation

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


Minimum age: N/A. Maximum age: 15 Years. Gender(s): Both.


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

Locations and Contacts

Iladevi Cataract & IOL Research Centre, Ahmedabad, Gujarat 380052, India
Additional Information

Related publications:

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.

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.

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.

Starting date: March 2008
Last updated: September 28, 2009

Page last updated: August 23, 2015

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