NCT00797134

Brief Summary

The main objective of this study is to characterize and correlate diabetic macular edema (DME), i.e. increased retinal thickness, measured by Optical Coherence Tomograph (OCT), and retinal visual function. The secondary objectives of this study are the analysis and characterization of DME progression over time (between two visits), and the comparison of OCT data obtained with different devices. The results of this study will be used exclusively for scientific purposes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 3, 2015

Status Verified

February 1, 2015

Enrollment Period

1.7 years

First QC Date

November 24, 2008

Last Update Submit

February 2, 2015

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Retinal thickness.

    After visit(s)

Secondary Outcomes (1)

  • Choroidal Thickness

    After visit(s)

Study Arms (1)

DR

Diabetic Retinopathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects followed regularly by their ophthalmologist performing, as part of their follow-up, optical coherence tomography with OCT, and fulfilling the inclusion/exclusion criteria will be included.

You may qualify if:

  • Diagnosis of DR
  • Females or Males
  • Age over 18 years
  • Signed Informed Consent Form

You may not qualify if:

  • Cataract or other eye disease that may interfere with fundus examinations
  • Vitreous syneresis or posterior vitreous detachment
  • Dilatation of the pupil \< 5 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIBILI

Coimbra, Coimbra District, 3000-548, Portugal

Location

Related Links

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • José Cunha-Vaz, MD, PhD

    Association for Innovation and Biomedical Research on Light and Image

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2008

First Posted

November 25, 2008

Study Start

November 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 3, 2015

Record last verified: 2015-02

Locations

PT(1)