Corneal Endothelium After Glaucoma Surgery
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 16, 2009 | ||||||||
| Last Updated Date | March 16, 2009 | ||||||||
| Start Date ICMJE | August 2003 | ||||||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Corneal Endothelium After Glaucoma Surgery | ||||||||
| Official Title ICMJE | Change in Corneal Endothelium After Glaucoma Surgery; Trabeculectomy and Glaucoma Implant Surgery | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| 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. Epub 2009 Jun 7. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00863018 | ||||||||
| Other Study ID Numbers ICMJE | CNUMC-09-04 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Chang-sik Kim, Department of Ophthalmology, College of Medicine, Chungnam national university | ||||||||
| Study Sponsor ICMJE | Chungnam National University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Chungnam National University | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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