Corneal Endothelium After Glaucoma Surgery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00863018

Enrollment

Registered

2009-03-17

Start date

2003-08-31

Completion date

2009-01-31

Last updated

2015-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Damage, Glaucoma, Intraocular Pressure

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area	1 and 2 years longitudinal follow up

Secondary

Measure	Time frame
Clinical factors associated with the damage of corneal endothelium after glaucoma surgery	1 and 2 years longitudinal follow up

Countries

South Korea

Outcome results