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CompletedNCT00986076Updated Sep 29, 2009

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

A Phase 4 interventional study of Enoxaparin and Balanced Salt Solution in Inflammation, sponsored by Iladevi Cataract and IOL Research Center. Completed at 1 site in India. Open to participants aged Up to 15 Years. Per ClinicalTrials.gov, last updated 2009-09-29.

Sponsored by Iladevi Cataract and IOL Research Center · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
Up to 15 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Inflammation

Keywords

  • Pediatric Cataract Surgery
  • Low-Molecular weight Heparin
  • Intraocular infusion
  • Anti-inflammatory effect
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 23 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Iladevi Cataract and IOL Research Center is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Enoxaparin infusion

    Congenital Cataract Surgery with IOL implantation Intraocular infusion of Enoxaparin

    Drug: Enoxaparin

  • Placebo comparator
    Balanced Salt Solution Infusion

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

    Drug: Balanced Salt Solution

Interventions

  • DrugEnoxaparin

    Enoxaparin 40 mg / 500 ml in Balanced Salt Solution

    Also known as: Clexane(Aventis)

  • DrugBalanced Salt Solution

    Intraocular infusion of Balanced Salt solution

    Also known as: BSS

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What researchers measure

Primary outcomes

  1. Anterior Segment Inflammation

    Time frame: 1 week

Secondary outcomes

  1. Anterior Segment inflammation

    Time frame: 1 month, 3 months

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Study locations

1 site
  • Iladevi Cataract & IOL Research Centre
    Ahmedabad, Gujarat 380052, India
08

References and documents

Publications

  • 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. PubMed 11777715 ↗
  • 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. PubMed 16490487 ↗
  • 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. PubMed 16490502 ↗
  • 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. PubMed 22541652 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00986076
Lead sponsor
Iladevi Cataract and IOL Research Center
First posted
Sep 29, 2009
Start date
Mar 2008
Primary completion
Apr 2009
Completion
Sep 2009
Last update
Sep 29, 2009

Study contacts

Viraj A Vasavada, MS
principal investigator · Iladevi Cataract & IOL Research Centre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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