NCT00986076

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2009

Completed
Last Updated

September 29, 2009

Status Verified

September 1, 2009

Enrollment Period

1.1 years

First QC Date

September 26, 2009

Last Update Submit

September 28, 2009

Conditions

Inflammation

Keywords

Pediatric Cataract SurgeryLow-Molecular weight HeparinIntraocular infusionAnti-inflammatory effect

Outcome Measures

Primary Outcomes (1)

  • Anterior Segment Inflammation

    1 week

Secondary Outcomes (1)

  • Anterior Segment inflammation

    1 month, 3 months

Study Arms (2)

Enoxaparin infusion

EXPERIMENTAL

Congenital Cataract Surgery with IOL implantation Intraocular infusion of Enoxaparin

Drug: Enoxaparin

Balanced Salt Solution Infusion

PLACEBO COMPARATOR

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

Drug: Balanced Salt Solution

Interventions

EnoxaparinDRUG

Enoxaparin 40 mg / 500 ml in Balanced Salt Solution

Also known as: Clexane(Aventis)
Enoxaparin infusion
Balanced Salt SolutionDRUG

Intraocular infusion of Balanced Salt solution

Also known as: BSS
Balanced Salt Solution Infusion

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children (0-15 years) with congenital cataract scheduled for surgery with IOL implantation and informed consent from the parents/legal guardian

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iladevi Cataract & IOL Research Centre

Ahmedabad, Gujarat, 380052, India

Location

Related Publications (4)

  • 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.

    PMID: 11777715BACKGROUND

  • 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.

    PMID: 16490487BACKGROUND

  • 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.

    PMID: 16490502BACKGROUND

  • 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.

    PMID: 22541652DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

EnoxaparinHanks Balanced Salt Solution

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Viraj A Vasavada, MS

    Iladevi Cataract & IOL Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2009

First Posted

September 29, 2009

Study Start

March 1, 2008

Primary Completion

April 1, 2009

Study Completion

September 1, 2009

Last Updated

September 29, 2009

Record last verified: 2009-09

Locations

IN(1)