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

NCT ID: NCT00986076

Last Updated: 2009-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-09-30

Brief Summary

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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

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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

Conditions

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Inflammation

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Enoxaparin infusion

Congenital Cataract Surgery with IOL implantation

Intraocular infusion of Enoxaparin

Group Type EXPERIMENTAL

Enoxaparin

Intervention Type DRUG

Enoxaparin 40 mg / 500 ml in Balanced Salt Solution

Balanced Salt Solution Infusion

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

Group Type PLACEBO_COMPARATOR

Balanced Salt Solution

Intervention Type DRUG

Intraocular infusion of Balanced Salt solution

Interventions

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Enoxaparin

Enoxaparin 40 mg / 500 ml in Balanced Salt Solution

Intervention Type DRUG

Balanced Salt Solution

Intraocular infusion of Balanced Salt solution

Intervention Type DRUG

Other Intervention Names

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Clexane(Aventis) BSS

Eligibility Criteria

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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
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iladevi Cataract and IOL Research Center

OTHER

Sponsor Role lead

Responsible Party

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Iladevi Cataract & IOL Research Centre

Principal Investigators

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Viraj A Vasavada, MS

Role: PRINCIPAL_INVESTIGATOR

Iladevi Cataract & IOL Research Centre

Locations

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Iladevi Cataract & IOL Research Centre

Ahmedabad, Gujarat, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 11777715 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16490487 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16490502 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22541652 (View on PubMed)

Other Identifiers

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08-010

Identifier Type: -

Identifier Source: org_study_id