Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery

This study has suspended participant recruitment.
(The present study was joining 2005-41-4933 into one study)
Sponsor:
Information provided by:
Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT00446277
First received: March 9, 2007
Last updated: May 9, 2008
Last verified: May 2008
  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 4

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

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
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

ClinicalTrials.gov Identifier: NCT00446277     History of Changes
Other Study ID Numbers: ASP01
Study First Received: March 9, 2007
Last Updated: May 9, 2008
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

Additional relevant MeSH terms:
Diabetes Mellitus
Cataract
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

ClinicalTrials.gov processed this record on September 18, 2014