Corneal Endothelium After Glaucoma Surgery - Full Text View

Purpose

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
Glaucoma Corneal Damage Intraocular Pressure


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Change in Corneal Endothelium After Glaucoma Surgery; Trabeculectomy and Glaucoma Implant Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

Further study details as provided by Chungnam National University:

Primary Outcome Measures:

Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area [ Time Frame: 1 and 2 years longitudinal follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical factors associated with the damage of corneal endothelium after glaucoma surgery [ Time Frame: 1 and 2 years longitudinal follow up ] [ Designated as safety issue: No ]


Enrollment:	61
Study Start Date:	August 2003
Study Completion Date:	January 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

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.

Eligibility


Ages Eligible for Study:	20 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863018

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

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
Study First Received:	March 16, 2009
Last Updated:	July 27, 2015
Health Authority:	Korea: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on September 29, 2016