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

September 26, 2009
September 28, 2009
March 2008
April 2009   (final data collection date for primary outcome measure)
Anterior Segment Inflammation [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00986076 on ClinicalTrials.gov Archive Site
Anterior Segment inflammation [ Time Frame: 1 month, 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Inflammation
  • Drug: Enoxaparin
    Enoxaparin 40 mg / 500 ml in Balanced Salt Solution
    Other Name: Clexane(Aventis)
  • Drug: Balanced Salt Solution
    Intraocular infusion of Balanced Salt solution
    Other Name: BSS
  • Experimental: Enoxaparin infusion

    Congenital Cataract Surgery with IOL implantation

    Intraocular infusion of Enoxaparin

    Intervention: Drug: Enoxaparin
  • Placebo Comparator: Balanced Salt Solution Infusion
    Congenital Cataract Surgery with IOL implantation Intraocular infusion of Balanced Salt Solution
    Intervention: Drug: Balanced Salt Solution

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
September 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
up to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00986076
08-010
Yes
Viraj A. Vasavada, MS, Iladevi Cataract & IOL Research Centre
Iladevi Cataract and IOL Research Center
Not Provided
Principal Investigator: Viraj A Vasavada, MS Iladevi Cataract & IOL Research Centre
Iladevi Cataract and IOL Research Center
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP