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NCT00446277 Clinical Trial

Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery

Diabetes Mellitus Clinical Trial

Official title:
Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT00446277
Other study ID # ASP01
Secondary ID
Status Suspended
Phase Phase 4
First received March 9, 2007
Last updated May 9, 2008
Start date January 2007
Est. completion date June 2007

Study information
Verified date May 2008
Source Frederiksberg University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics CommitteeDenmark: National Board of Health
Study type Observational

Clinical Trial Summary

The aim of the present study is to evaluate changes in the morphology and function of the corneal endothelium before and after cataract surgery in patients with diabetes type II. Also to explain if determination of HgbA1c in diabetics is a predictor for the changes in morphology and function.

Description:

Thirty patients with Diabetes type II and thirty non-diabetes patients scheduled to cataract surgery (phacoemulsification with intraocular lens implantation) were invited to participate in the study. Preoperatively, all patients had a full eye examination and 3 endothelial cell photos were taken.

Three months postoperatively the patients were called for a re-examination including 3 endothelial cell photos. The function of the cornea is dependent of the number and morphology of the endothelial cells, and even small traumas like cataract surgery may disrupt the cornea integrity leading to corneal haze and blur. Diabetics may be more vulnerable to corneal stress.

Recruitment information / eligibility
Status Suspended
Enrollment 30
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Patients with cataract scheduled for surgery

Exclusion Criteria:

- Patients with corneal diseases, glaucoma or uveitis, previous intraocular surgery or eye traumas.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• cataract surgery

Locations
Country Name City State
Denmark Department of Ophthalmology, Frederiksberg University Hospital Frederiksberg Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary corneal endothelial cell count (cells / mm2)
Primary percentage of hexagonal cells
Primary variation in cell size
Primary central corneal thickness
Secondary visual acuity
Secondary intraocular pressure
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