Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes Mellitus Type II

NCT ID: NCT01078103

Last Updated: 2010-03-02

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

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Diabetes Cataract

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Cataract, diabetes

Exclusion Criteria

* Corneal disease
* Uveitis
* Previous intraocular surgery and diabetes type I
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frederiksberg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Frederiksberg University Hospital

Principal Investigators

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Allan V Storr-Paulsen, MD

Role: STUDY_DIRECTOR

Frederiksberg University Hospital

Locations

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Frederiksberg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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J.nr.2005-41-4933

Identifier Type: -

Identifier Source: org_study_id

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