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

Overview

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.

Full Title of Study: “Randomized Clinical Trial Evaluating Anti-inflammatory Effect of Low Molecular-Weight Heparin in Pediatric Cataract and Intraocular Lens Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2009

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

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Anterior Segment Inflammation
    • Time Frame: 1 week

Secondary Measures

  • Anterior Segment inflammation
    • Time Frame: 1 month, 3 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Iladevi Cataract and IOL Research Center
  • Provider of Information About this Clinical Study
    • Viraj A. Vasavada, MS, Iladevi Cataract & IOL Research Centre
  • Overall Official(s)
    • Viraj A Vasavada, MS, Principal Investigator, Iladevi Cataract & IOL Research Centre

References

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. doi: 10.1016/s0886-3350(01)00861-6.

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. doi: 10.1016/j.ajo.2005.08.020.

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. doi: 10.1016/j.ajo.2005.11.012. No abstract available.

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