Corneal Endothelium After Glaucoma Surgery

Glaucoma Clinical Trial

Official title:

Change in Corneal Endothelium After Glaucoma Surgery; Trabeculectomy and Glaucoma Implant Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863018
• Other study ID #: CNUMC-09-04
• Status: Completed
• Phase: N/A
• First received: March 16, 2009
• Last updated: July 27, 2015
• Start date: August 2003
• Est. completion date: January 2009

Study information

• Verified date: July 2015
• Source: Chungnam National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Corneal Damage
• Glaucoma
• Intraocular Pressure

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Chungnam National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area		1 and 2 years longitudinal follow up	No
Secondary	Clinical factors associated with the damage of corneal endothelium after glaucoma surgery		1 and 2 years longitudinal follow up	No