Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT00986076
First received: September 26, 2009
Last updated: September 28, 2009
Last verified: September 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Cataract
Inflammation
Eye Diseases
Lens Diseases
Pathologic Processes
Anti-Inflammatory Agents
Dalteparin
Heparin
Heparin, Low-Molecular-Weight
Pharmaceutical Solutions
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014