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OpenTrials
Completed

NCT Number: NCT00863018

Corneal Endothelium After Glaucoma Surgery

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chungnam National University Hospital

Daejeon, 301-721, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

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

    Time frame: 1 and 2 years longitudinal follow up

Sponsors and collaborators

Lead sponsor

Chungnam National University

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2009
First posted
Mar 17, 2009
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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