NCT00446277

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.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

May 12, 2008

Status Verified

May 1, 2008

Enrollment Period

5 months

First QC Date

March 9, 2007

Last Update Submit

May 9, 2008

Conditions

Diabetes Mellitus

Keywords

cataract surgery, endothelial cell, cell loss, diabetesmellitus type II

Outcome Measures

Primary Outcomes (4)

  • corneal endothelial cell count (cells / mm2)

  • percentage of hexagonal cells

  • variation in cell size

  • central corneal thickness

Secondary Outcomes (2)

  • visual acuity

  • intraocular pressure

Interventions

cataract surgeryPROCEDURE

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with cataract scheduled for surgery

You may not qualify if:

  • Patients with corneal diseases, glaucoma or uveitis, previous intraocular surgery or eye traumas.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Frederiksberg University Hospital

Frederiksberg, Copenhagen, 2000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Allan Storr-Paulsen, MD

    Frederiksberg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 9, 2007

First Posted

March 12, 2007

Study Start

January 1, 2007

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

May 12, 2008

Record last verified: 2008-05

Locations

DK(1)