Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery

• Sponsor: Frederiksberg University Hospital (Other)
• Overall Status: Suspended
• CT.gov ID: NCT00446277
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 6

Study Details

Study Description

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

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 Design

• Study Type: Observational
• Anticipated 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: Jan 1, 2007
• Anticipated Primary Completion Date: Jun 1, 2007
• Anticipated Study Completion Date: Jun 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00446277
• Other Study ID Numbers: ASP01
• First Posted: Mar 12, 2007
• Last Update Posted: May 12, 2008
• Last Verified: May 1, 2008

• Keywords provided by , ,: cataract surgery, endothelial cell, cell loss, diabetes; mellitus type II
• Additional relevant MeSH terms: Cataract; Corneal Endothelial Cell Loss; Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of May 12, 2008