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Corneal Endothelium After Glaucoma Surgery

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ClinicalTrials.gov Identifier: NCT00863018
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : July 29, 2015
Sponsor:
Information provided by (Responsible Party):
Chang-sik Kim, Chungnam National University

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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



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 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 17, 2009    Key Record Dates
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