Corneal Endothelium After Glaucoma Surgery

NCT ID: NCT00863018

Last Updated: 2015-07-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2009-01-31

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.

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.

Conditions

Glaucoma; Corneal Damage; Intraocular Pressure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control

Eyes with glaucoma and on anti-glaucoma medication but without glaucoma surgery

No interventions assigned to this group

Implant surgery

Eyes underwent Ahmed glaucoma valve implantation

No interventions assigned to this group

Trabeculectomy

Eyes underwent conventional trabeculectomy with mitomycin-C

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chungnam National University

OTHER

Sponsor Role: lead

Responsible Party

Chang-sik Kim

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Young-ha Lee, MD, PhD

Role: STUDY_DIRECTOR

Research Institute for Medical Science, Chungnam National University

Chang-sik Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmology, College of Medicine, Chungnam National University

Locations

Chungnam National University Hospital

Daejeon, , South Korea

Countries

South Korea

References

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. doi: 10.1016/j.ajo.2009.04.016. Epub 2009 Jun 7.

Reference Type: DERIVED

PMID: 19505676 (View on PubMed)

Other Identifiers

CNUMC-09-04

Identifier Type: -

Identifier Source: org_study_id