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Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes Mellitus Type II

This study has been completed.
Sponsor:
Information provided by:
Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT01078103
First received: March 1, 2010
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

Some studies indicated that the diabetic corneal endothelium is morphologically abnormal and may be at risk in any intraocular surgical procedure, while others showed no significant differences between diabetic and non-diabetic corneal endothelium.The purpose of this study is to investigate the differences in corneal endothelial cell density and morphology in diabetic patients and normal patients after phacoemulsification with intraocular lens implantation.To investigate if haemoglobin A1c can be used as a predictor of corneal endothelial cell changes after phacoemulsification.


Condition Phase
Diabetes
Cataract
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Frederiksberg University Hospital:

Enrollment: 60
Study Start Date: July 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Some studies indicated that the diabetic corneal endothelium is morphologically abnormal and may be at risk in any intraocular surgical procedure, while others showed no significant differences between diabetic and non-diabetic corneal endothelium.The purpose of this study is to investigate the differences in corneal endothelial cell density and morphology in diabetic patients and normal patients after phacoemulsification with intraocular lens implantation.To investigate if haemoglobin A1c can be used as a predictor of corneal endothelial cell changes after phacoemulsification.

Specular microscopy photos will be taken pre-. and 3 month postoperatively. Cellular parameters will be compared between the two groups prior and post surgery. Clinical significant difference is defined as 1 SD (300 cell/mm2)

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

30 typoe II diabetic and 30 non diabetic undergoing catarct surgery

Criteria

Inclusion Criteria:

  • Cataract, diabetes

Exclusion Criteria:

  • Corneal disease
  • Uveitis
  • Previous intraocular surgery and diabetes type I
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078103

Locations
Denmark
Frederiksberg Hospital
Copenhagen, Denmark, 2000
Sponsors and Collaborators
Frederiksberg University Hospital
Investigators
Study Director: Allan V Storr-Paulsen, MD Frederiksberg University Hospital
  More Information

No publications provided

Responsible Party: Allan Storr-Paulsen, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01078103     History of Changes
Other Study ID Numbers: J.nr.2005-41-4933
Study First Received: March 1, 2010
Last Updated: March 1, 2010
Health Authority: Denmark: National Board of Health

Keywords provided by Frederiksberg University Hospital:
Diabetes Mellitus
cornea endothelium
cell loss
cataract surgery

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cataract
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013