Corneal Endothelial Changes Following Pediatric Cataract Surgery With IOL Implantation

NCT ID: NCT01504607

Last Updated: 2012-01-05

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

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-10-31

Brief Summary

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Cataract surgery is known to cause loss of corneal endothelial cells. In adults, it is reported that anywhere between 2 to 15% loss of corneal endothelial cell density occurs following cataract surgery. However, no data is available regarding endothelial changes after cataract surgery with IOL implantation in pediatric eyes.

The aim of this study is to prospectively observe changes in endothelial cell density, coefficient of variation and hexagonality following cataract surgery with IOL implantation in pediatric eyes.

Detailed Description

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Conditions

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Congenital Cataract Surgery IOL Implantation Change in Corneal Endothelial Cell Morphology

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Congenital cataract surgery with IOL implantation

Congenital cataract surgery was performed with or without anterior vitrectomy, followed by in the bag IOL implantation

Congenital Cataract Surgery

Intervention Type PROCEDURE

Congenital cataract surgery with IOL implantation

Interventions

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Congenital Cataract Surgery

Congenital cataract surgery with IOL implantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Eyes undergoing pediatric cataract surgery with IOL implantation at Iladevi Cataract \& IOL Research Center, Ahmedabad, India.
* Children older than 4 years undergoing cataract surgery with IOL implantation were included.
Minimum Eligible Age

4 Years

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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Responsibility Role SPONSOR

References

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Vasavada AR, Praveen MR, Vasavada VA, Shah SK, Vasavada V, Trivedi RH. Corneal endothelial morphologic assessment in pediatric cataract surgery with intraocular lens implantation: a comparison of preoperative and early postoperative specular microscopy. Am J Ophthalmol. 2012 Aug;154(2):259-265.e1. doi: 10.1016/j.ajo.2012.02.018. Epub 2012 Apr 27.

Reference Type DERIVED
PMID: 22541660 (View on PubMed)

Other Identifiers

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2011-13

Identifier Type: OTHER

Identifier Source: secondary_id

ICIRC-Pedspec

Identifier Type: -

Identifier Source: org_study_id

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