Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery

This study has been suspended.

( The present study was joining 2005-41-4933 into one study )

First Received: March 9, 2007 Last Updated: May 9, 2008 History of Changes

Sponsored by:	Frederiksberg University Hospital
Information provided by:	Frederiksberg University Hospital
ClinicalTrials.gov Identifier:	NCT00446277

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus	Procedure: cataract surgery	Phase IV

MedlinePlus related topics: Cataract Diabetes Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery

Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:

corneal endothelial cell count (cells / mm2)
percentage of hexagonal cells
variation in cell size
central corneal thickness

Secondary Outcome Measures:

visual acuity
intraocular pressure

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	January 2007
Estimated Study Completion Date:	June 2007
Estimated Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with cataract scheduled for surgery

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446277

Locations

Denmark, Copenhagen
Department of Ophthalmology, Frederiksberg University Hospital
Frederiksberg, Copenhagen, Denmark, 2000

Sponsors and Collaborators

Frederiksberg University Hospital

Investigators

Principal Investigator:

Allan Storr-Paulsen, MD

Frederiksberg University Hospital

More Information

No publications provided

Study ID Numbers:	ASP01
Study First Received:	March 9, 2007
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00446277 History of Changes
Health Authority:	Denmark: Ethics Committee; Denmark: National Board of Health

Keywords provided by Frederiksberg University Hospital:

cataract surgery, endothelial cell, cell loss, diabetes
mellitus type II

Study placed in the following topic categories:

Metabolic Diseases
Eye Diseases
Cataract
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Lens Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Eye Diseases
Cataract
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Lens Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009