Clinical trial NCT00863018: Corneal Endothelium After Glaucoma Surgery
Official title: Change in Corneal Endothelium After Glaucoma Surgery; Trabeculectomy and Glaucoma Implant Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Corneal Damage
Intraocular Pressure
Keywords: Corneal endothelial cell
Specular microscopy
Glaucoma implant surgery
Ahmed glaucoma valve
Trabeculectomy
Lead sponsor: Chungnam National University
Sponsor class: OTHER
First posted: 2009-03-17
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery

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.

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

Primary outcomes:
measure: Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area
timeFrame: 1 and 2 years longitudinal follow up
Secondary outcomes:
measure: Clinical factors associated with the damage of corneal endothelium after glaucoma surgery
timeFrame: 1 and 2 years longitudinal follow up
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
affiliation: Research Institute for Medical Science, Chungnam National University
name: Young-ha Lee, MD, PhD
role: STUDY_DIRECTOR
affiliation: Ophthalmology, College of Medicine, Chungnam National University
name: Chang-sik Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.