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Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery

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ClinicalTrials.gov Identifier: NCT00446277
Recruitment Status : Suspended (The present study was joining 2005-41-4933 into one study)
First Posted : March 12, 2007
Last Update Posted : May 12, 2008
Information provided by:
Frederiksberg University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Procedure: cataract surgery Phase 4

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.

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery
Study Start Date : January 2007
Estimated Primary Completion Date : June 2007
Estimated Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Primary Outcome Measures :
  1. corneal endothelial cell count (cells / mm2)
  2. percentage of hexagonal cells
  3. variation in cell size
  4. central corneal thickness

Secondary Outcome Measures :
  1. visual acuity
  2. intraocular pressure

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with cataract scheduled for surgery

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446277

Department of Ophthalmology, Frederiksberg University Hospital
Frederiksberg, Copenhagen, Denmark, 2000
Sponsors and Collaborators
Frederiksberg University Hospital
Principal Investigator: Allan Storr-Paulsen, MD Frederiksberg University Hospital

ClinicalTrials.gov Identifier: NCT00446277     History of Changes
Other Study ID Numbers: ASP01
First Posted: March 12, 2007    Key Record Dates
Last Update Posted: May 12, 2008
Last Verified: May 2008

Keywords provided by Frederiksberg University Hospital:
cataract surgery, endothelial cell, cell loss, diabetes
mellitus type II

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Corneal Endothelial Cell Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lens Diseases
Eye Diseases
Corneal Diseases
Postoperative Complications
Pathologic Processes