Corneal Endothelium After Glaucoma Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Chungnam National University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chungnam National University
ClinicalTrials.gov Identifier:
NCT00863018
First received: March 16, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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:


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 ]

Estimated Enrollment: 100
Study Start Date: August 2003
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: August 2009 (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
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

Contacts
Contact: Chang-sik Kim, MD, PhD 82-42-280-7606 kcs61@cnu.ac.kr
Contact: Eun-kyung Lww, MD 82-42-280-7604 med001@hanmail.net

Locations
Korea, Republic of
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of, 301-721
Contact: Chang-sik Kim, MD, PhD    82-42-280-7600    kcs61@cnu.ac.kr   
Contact: Eun-kyung Lee, MD    82-42-280-7604    med001@hanmail.net   
Principal Investigator: Chang-sik Kim, MD, PhD         
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

No publications provided by Chungnam National University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chang-sik Kim, Department of Ophthalmology, College of Medicine, 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: March 16, 2009
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
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 29, 2014