Corneal Endothelium After Glaucoma Surgery

July 27, 2015 updated by: Chang-sik Kim, Chungnam National University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- - Daejeon, Korea, Republic of, 301-721
    - Chungnam National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Control Eyes with glaucoma and on anti-glaucoma medication but without glaucoma surgery
Implant surgery Eyes underwent Ahmed glaucoma valve implantation
Trabeculectomy Eyes underwent conventional trabeculectomy with mitomycin-C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area Time Frame: 1 and 2 years longitudinal follow up	1 and 2 years longitudinal follow up

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical factors associated with the damage of corneal endothelium after glaucoma surgery Time Frame: 1 and 2 years longitudinal follow up	1 and 2 years longitudinal follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chungnam National University

Investigators

Study Director: Young-ha Lee, MD, PhD, Research Institute for Medical Science, Chungnam National University
Principal Investigator: Chang-sik Kim, MD, PhD, Ophthalmology, College of Medicine, Chungnam National University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Lee EK, Yun YJ, Lee JE, Yim JH, Kim CS. Changes in corneal endothelial cells after Ahmed glaucoma valve implantation: 2-year follow-up. Am J Ophthalmol. 2009 Sep;148(3):361-7. doi: 10.1016/j.ajo.2009.04.016. Epub 2009 Jun 7.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

March 16, 2009

First Submitted That Met QC Criteria