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

Primary Purpose

Inflammation

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Enoxaparin
Balanced Salt Solution
Sponsored by
Iladevi Cataract and IOL Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation focused on measuring Pediatric Cataract Surgery, Low-Molecular weight Heparin, Intraocular infusion, Anti-inflammatory effect

Eligibility Criteria

undefined - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Iladevi Cataract & IOL Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Enoxaparin infusion

Balanced Salt Solution Infusion

Arm Description

Congenital Cataract Surgery with IOL implantation Intraocular infusion of Enoxaparin

Congenital Cataract Surgery with IOL implantation Intraocular infusion of Balanced Salt Solution

Outcomes

Primary Outcome Measures

Anterior Segment Inflammation

Secondary Outcome Measures

Anterior Segment inflammation

Full Information

First Posted
September 26, 2009
Last Updated
September 28, 2009
Sponsor
Iladevi Cataract and IOL Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT00986076
Brief Title
Clinical Trial on Anti-inflammatory Effect of Low-Molecular Weight Heparin in Pediatric Cataract Surgery
Official Title
Randomized Clinical Trial Evaluating Anti-inflammatory Effect of Low Molecular-Weight Heparin in Pediatric Cataract and Intraocular Lens Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Iladevi Cataract and IOL Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
Pediatric Cataract Surgery, Low-Molecular weight Heparin, Intraocular infusion, Anti-inflammatory effect

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enoxaparin infusion
Arm Type
Experimental
Arm Description
Congenital Cataract Surgery with IOL implantation Intraocular infusion of Enoxaparin
Arm Title
Balanced Salt Solution Infusion
Arm Type
Placebo Comparator
Arm Description
Congenital Cataract Surgery with IOL implantation Intraocular infusion of Balanced Salt Solution
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
Clexane(Aventis)
Intervention Description
Enoxaparin 40 mg / 500 ml in Balanced Salt Solution
Intervention Type
Drug
Intervention Name(s)
Balanced Salt Solution
Other Intervention Name(s)
BSS
Intervention Description
Intraocular infusion of Balanced Salt solution
Primary Outcome Measure Information:
Title
Anterior Segment Inflammation
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Anterior Segment inflammation
Time Frame
1 month, 3 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viraj A Vasavada, MS
Organizational Affiliation
Iladevi Cataract & IOL Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iladevi Cataract & IOL Research Centre
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380052
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
11777715
Citation
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.
Results Reference
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PubMed Identifier
16490487
Citation
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.
Results Reference
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PubMed Identifier
16490502
Citation
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.
Results Reference
background
PubMed Identifier
22541652
Citation
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. doi: 10.1016/j.ajo.2012.02.021. Epub 2012 Apr 27.
Results Reference
derived

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

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