Clinical trial NCT00986076: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammation
Keywords: Pediatric Cataract Surgery
Low-Molecular weight Heparin
Intraocular infusion
Anti-inflammatory effect
Lead sponsor: Iladevi Cataract and IOL Research Center
Sponsor class: OTHER
First posted: 2009-09-29
Enrollment: 23
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Anterior Segment Inflammation
timeFrame: 1 week
Secondary outcomes:
measure: Anterior Segment inflammation
timeFrame: 1 month, 3 months
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Iladevi Cataract & IOL Research Centre
state: Gujarat
Study officials:
affiliation: Iladevi Cataract & IOL Research Centre
name: Viraj A Vasavada, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.