Corneal Endothelium After Glaucoma Surgery

NCT00863018 | Completed DMC

• 1 other identifier: CNUMC-09-04
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Corneal Damage; Intraocular Pressure

Keywords

Corneal endothelial cell; Specular microscopy; Glaucoma implant surgery; Ahmed glaucoma valve; Trabeculectomy

Outcome Measures

Primary Outcomes (1)

• Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area

  1 and 2 years longitudinal follow up

Secondary Outcomes (1)

• Clinical factors associated with the damage of corneal endothelium after glaucoma surgery

  1 and 2 years longitudinal follow up

Study Arms (3)

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery

You may qualify if:

• Patients who need glaucoma surgery for intraocular pressure control

You may not qualify if:

• congenital glaucoma
• Pre-existing corneal abnormality
• lost from follow up without any ocular problem within 6 months from surgery

Sponsors & Collaborators

• Chungnam National University: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, 301-721, South Korea

Location

Related Publications (1)

• 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.

  PMID: 19505676 DERIVED

MeSH Terms

Conditions

Glaucoma; Corneal Injuries

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Corneal Diseases; Wounds and Injuries

Study Officials

• Young-ha Lee, MD, PhD

  Research Institute for Medical Science, Chungnam National University

  STUDY DIRECTOR

• Chang-sik Kim, MD, PhD

  Ophthalmology, College of Medicine, Chungnam National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: March 17, 2009
• Study Start: August 1, 2003
• Primary Completion: August 1, 2008
• Study Completion: January 1, 2009
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

KR (1)