AS-OCT Study in Diabetic Retinopathy
Anterior Segment- Optical Coherence Tomography as Early Biomarker in Diabetic Retinopathy
1 other identifier
observational
30
1 country
1
Brief Summary
This study evaluates the corneal features using anterior segment - optical coherence tomography in patients affected by type 2 diabetes mellitus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2020
Shorter than P25 for all trials
1 active site
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, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedFirst Submitted
Initial submission to the registry
July 25, 2021
CompletedFirst Posted
Study publicly available on registry
August 5, 2021
CompletedAugust 5, 2021
July 1, 2021
10 months
July 25, 2021
July 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The measurements of corneal features in patients with type 2 diabetes mellitus, using anterior segment-optical coherence tomography
The parameters analyzed by anterior segment-optical coherence tomography angiography were: total corneal, epithelial and stromal thicknesses
twelve months
Study Arms (2)
Patients with type 2 diabetes mellitus
The patients with previous diagnosis of type 2 diabetes mellitus, without signs of diabetic retinopathy
Healthy subjects
Healthy subjects without actual and previous ocular diseases
Interventions
Each subject underwent anterior segment -optical coherence tomography to evaluate the total corneal, epthelium and stromal thicknesses.
Eligibility Criteria
The participans were older than 50 years with previous diagnosis of type 2 diabetes mellitus without signs of diabetic retinopathy. The participans did not present other ophthalmological diseases
You may qualify if:
- age older than 50 years
- diagnosis of previous type 2 diabetes mellitus
- absence of signs of diabetic retinopathy
- absence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- absence of significant lens opacities, low-quality OCT and OCT-A images
You may not qualify if:
- age younger than 50 years
- absence of previous diagnosis of type 2 diabetes mellitus
- presence of signs of diabetic retinopathy
- presence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- presence of significant lens opacities, low-quality OCT and OCT-A images.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Naples "Federico II"
Naples, 80100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gilda Cennamo
Federico II University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 25, 2021
First Posted
August 5, 2021
Study Start
July 1, 2020
Primary Completion
April 25, 2021
Study Completion
April 30, 2021
Last Updated
August 5, 2021
Record last verified: 2021-07