NCT01078103

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
Last Updated

March 2, 2010

Status Verified

August 1, 2009

Enrollment Period

2.8 years

First QC Date

March 1, 2010

Last Update Submit

March 1, 2010

Conditions

Keywords

Diabetes Mellituscornea endotheliumcell losscataract surgery

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

30 typoe II diabetic and 30 non diabetic undergoing catarct surgery

You may qualify if:

  • Cataract, diabetes

You may not qualify if:

  • Corneal disease
  • Uveitis
  • Previous intraocular surgery and diabetes type I

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frederiksberg Hospital

Copenhagen, 2000, Denmark

Location

MeSH Terms

Conditions

Diabetes MellitusCataract

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLens DiseasesEye Diseases

Study Officials

  • Allan V Storr-Paulsen, MD

    Frederiksberg University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2010

First Posted

March 2, 2010

Study Start

July 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

March 2, 2010

Record last verified: 2009-08

Locations