- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00446277
Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery
Study Overview
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Copenhagen
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Frederiksberg, Copenhagen, Denmark, 2000
- Department of Ophthalmology, Frederiksberg University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with cataract scheduled for surgery
Exclusion Criteria:
- Patients with corneal diseases, glaucoma or uveitis, previous intraocular surgery or eye traumas.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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corneal endothelial cell count (cells / mm2)
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percentage of hexagonal cells
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variation in cell size
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central corneal thickness
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Secondary Outcome Measures
Outcome Measure |
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visual acuity
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intraocular pressure
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Collaborators and Investigators
Investigators
- Principal Investigator: Allan Storr-Paulsen, MD, Frederiksberg University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASP01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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