Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery

NCT ID: NCT00446277

Last Updated: 2008-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Keywords

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cataract surgery, endothelial cell, cell loss, diabetes mellitus type II

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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cataract surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with cataract scheduled for surgery

Exclusion Criteria

* Patients with corneal diseases, glaucoma or uveitis, previous intraocular surgery or eye traumas.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frederiksberg University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Allan Storr-Paulsen, MD

Role: PRINCIPAL_INVESTIGATOR

Frederiksberg University Hospital

Locations

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Department of Ophthalmology, Frederiksberg University Hospital

Frederiksberg, Copenhagen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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ASP01

Identifier Type: -

Identifier Source: org_study_id