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Clinical Trials/NCT00863018
NCT00863018
Completed
Not Applicable

Change in Corneal Endothelium After Glaucoma Surgery; Trabeculectomy and Glaucoma Implant Surgery

Chungnam National University1 site in 1 country61 target enrollmentAugust 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glaucoma
Sponsor
Chungnam National University
Enrollment
61
Locations
1
Primary Endpoint
Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this trial is to study the change in corneal endothelial cell after glaucoma surgery, non-contact specular microscopic examination is performed for the patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery prospectively. Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area will be analyzed and compared to the baseline and between the types of the surgeries.

Detailed Description

To study the change in corneal endothelial cell after glaucoma surgery, non-contact specular microscopic examination is performed for the patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery prospectively. Specular microscopy using non-contact type specular microscope (Noncon Robo SP-8000, Konan Medical Inc., Tokyo, Japan) was performed by one experienced examiner before surgery and 1, 6, 12, 18, and 24 months after surgery. All examinations were done at the center, superior, superonasal, and superotemporal area of the cornea, while the patient maintain fixation at the target in the equipment. The follow-up was stopped if serious complication requiring surgical treatment was developed or additional intraocular pressure lowering surgery is needed, and the data before the second surgery were collected.

Registry
clinicaltrials.gov
Start Date
August 2003
End Date
January 2009
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chang-sik Kim

professor

Chungnam National University

Eligibility Criteria

Inclusion Criteria

  • Patients who need glaucoma surgery for intraocular pressure control

Exclusion Criteria

  • congenital glaucoma
  • Pre-existing corneal abnormality
  • lost from follow up without any ocular problem within 6 months from surgery

Outcomes

Primary Outcomes

Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area

Time Frame: 1 and 2 years longitudinal follow up

Secondary Outcomes

  • Clinical factors associated with the damage of corneal endothelium after glaucoma surgery(1 and 2 years longitudinal follow up)

Study Sites (1)

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