NCT05746975Completed
Diabetic Retinopathy Classification: ETDRS 7-fields vs Widefield Imaging (ClarusDR)
Diabetic Retinopathy Classification: ETDRS 7-fields vs Widefield Imaging (Clarus 500 and Optos California)
Source: ClinicalTrials.gov · Last updated 27 Nov 2024
Brief summary (registry, in English)
The goal of this observational study is to analyse and compare Diabetic Retinopathy severity level using 30º ETDRS 7-fields and Wide-field Imaging techniques using Clarus 500 (Carl Zeiss Meditech Inc., Dublin, USA) and Optos (Optos, Dunfermline, UK) in diabetic patients with mild to moderate diabetic retinopathy. The main questions it aims to answer are: 1\. To compare the Clarus 500TM wide-field imaging technique with the ETDRS 7-fields method in the assessment of DR severity level using the ETDRS DRSS.2. To compare the two wide-field imaging techniques (Clarus 500TM vs OptosTM) in the assessment of DR severity level using the ETDRS DRSS.3. To evaluate the peripheral area imaged by the wide-field Clarus 500TM and OptosTM to characterize DR lesions distribution (predominantly observed within or outside the ETDRS 7-fields) and severity (according to the ETDRS standard photos).4. To determine the relevance and frequency of DR PPL, located outside the ETDRS 7-fields area, and to explore PPL occurrence in different DR severity levels. Participants will undergo a non-invasive ophthalmological examination, which includes BCVA, 7-fields CFP and UWF FP to assess ETDRS DRSS level.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 81 (actual)
- First submitted
- 6 Feb 2023
- Start date
- 3 Apr 2023
- Primary completion date
- 4 Nov 2024
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Diseases
- Diabetic eye disease
- NCT number
- NCT05746975
What you commit to
- Study type: Observational
- Participants enrolled: 81
- From 3 Apr 2023 to the primary completion date, 4 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cataract or other eye disease that may interfere with fundus examinations
- Other retinal vascular disease than DR
Other
- Glaucoma
- Refractive errors \> to + or - 5 Diopters
- Pupil diameter of less than 5 mm
- Poor quality images due to artifacts, movements, or media opacities
Who the study is looking for
- DM type 2 according to 1985 World Health Organization (WHO) criteria
- Age between 35 and 80 years
- BCVA ≥ 75 letters (20 /32)
- Refraction with a spherical equivalent less than 5 Diopters
- NPDR levels 35 and 43-47 (based on the ETDRS criteria - 7 fields CFP)
Age in the registry: 35 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AIBILI-CEC (AIBILI- Clinical Trials Centre) Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
Related publications
- Cross-device consistency in diabetic retinopathy grading: a comparative analysis of widefield versus standard 30-35° - the ClarusDR study.Br J Ophthalmol · 2026 · PMID 42493232
This page is information, not medical advice. Discuss any trial with your doctor.