Corneal Endothelium After Glaucoma Surgery

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Glaucoma; Corneal Damage; Intraocular Pressure

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 Design

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Study Type :	Observational
Actual Enrollment :	61 participants
Observational Model:	Case Control
Time Perspective:	Prospective
Official Title:	Change in Corneal Endothelium After Glaucoma Surgery; Trabeculectomy and Glaucoma Implant Surgery
Study Start Date :	August 2003
Actual Primary Completion Date :	August 2008
Actual Study Completion Date :	January 2009

Groups and Cohorts

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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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Chang-sik Kim, professor, Chungnam National University
ClinicalTrials.gov Identifier:	NCT00863018 History of Changes
Other Study ID Numbers:	CNUMC-09-04
First Posted:	March 17, 2009
Last Update Posted:	July 29, 2015
Last Verified:	July 2015

Keywords provided by Chang-sik Kim, Chungnam National University:

Corneal endothelial cell; Specular microscopy; Glaucoma implant surgery; Ahmed glaucoma valve; Trabeculectomy

Additional relevant MeSH terms:

Glaucoma; Corneal Injuries; Ocular Hypertension; Eye Diseases; Eye Injuries; Facial Injuries	Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Corneal Diseases; Wounds and Injuries