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Corneal Endothelium After Glaucoma Surgery
This study has been completed.
Sponsor:
Chungnam National University
Information provided by (Responsible Party):
Chang-sik Kim, Chungnam National University
ClinicalTrials.gov Identifier:
NCT00863018
First received: March 16, 2009
Last updated: July 27, 2015
Last verified: July 2015
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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 Chang-sik Kim, 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 ]
Secondary Outcome Measures:
- Clinical factors associated with the damage of corneal endothelium after glaucoma surgery [ Time Frame: 1 and 2 years longitudinal follow up ]
| 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) |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00863018
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):
| 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 |
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 |
ClinicalTrials.gov processed this record on June 27, 2017