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

Purpose

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.

Condition	Intervention	Phase
Inflammation	Drug: Enoxaparin Drug: Balanced Salt Solution	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Randomized Clinical Trial Evaluating Anti-inflammatory Effect of Low Molecular-Weight Heparin in Pediatric Cataract and Intraocular Lens Surgery

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Cataract Dietary Sodium

Drug Information available for: Sodium chloride Heparin Enoxaparin sodium Dalteparin sodium

U.S. FDA Resources

Further study details as provided by Iladevi Cataract and IOL Research Center:

Primary Outcome Measures:

Anterior Segment Inflammation [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Anterior Segment inflammation [ Time Frame: 1 month, 3 months ] [ Designated as safety issue: No ]

Enrollment:	23
Study Start Date:	March 2008
Study Completion Date:	September 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Enoxaparin infusion Congenital Cataract Surgery with IOL implantation Intraocular infusion of Enoxaparin	Drug: Enoxaparin Enoxaparin 40 mg / 500 ml in Balanced Salt Solution Other Name: Clexane(Aventis)
Placebo Comparator: Balanced Salt Solution Infusion Congenital Cataract Surgery with IOL implantation Intraocular infusion of Balanced Salt Solution	Drug: Balanced Salt Solution Intraocular infusion of Balanced Salt solution Other Name: BSS

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

Eligibility

Ages Eligible for Study:	up to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986076

Locations

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

Sponsors and Collaborators

Iladevi Cataract and IOL Research Center

Investigators

Principal Investigator:

Viraj A Vasavada, MS

Iladevi Cataract & IOL Research Centre

More Information

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. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vasavada VA, Praveen MR, Shah SK, Trivedi RH, Vasavada AR. Anti-inflammatory effect of low-molecular-weight heparin in pediatric cataract surgery: a randomized clinical trial. Am J Ophthalmol. 2012 Aug;154(2):252-258.e4. Epub 2012 Apr 27.

Responsible Party:	Viraj A. Vasavada, MS, Iladevi Cataract & IOL Research Centre
ClinicalTrials.gov Identifier:	NCT00986076 History of Changes
Other Study ID Numbers:	08-010
Study First Received:	September 26, 2009
Last Updated:	September 28, 2009
Health Authority:	India: Institutional Review Board

Keywords provided by Iladevi Cataract and IOL Research Center:

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

Additional relevant MeSH terms:

Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Anti-Inflammatory Agents
Heparin
Heparin, Low-Molecular-Weight
Dalteparin

Enoxaparin
Therapeutic Uses
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013