Eye scans could predict vision loss in diabetes patients
NCT ID NCT04636307
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at 202 adults with type 2 diabetes and early-stage diabetic eye disease (non-proliferative diabetic retinopathy). Researchers used non-invasive eye scans to find markers that could predict if the disease would get worse or lead to sight-threatening problems. The goal was to better understand how the retina changes over time, without any treatment being tested.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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202 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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May 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Diabetes Type-2 and NPDR (levels 35, 43, 47 or 53)
- Ages
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35 to 90 years
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA * Diabetes type 2 according to 1985 WHO criteria; * Age between 35 and 90 years; * NPDR levels 35, 43, 47 or 53 (based on the ETDRS criteria - 7 fields CFP) after confirmation by the Reading Centre; * Refraction with a spherical equivalent less than 5 Dp; * Informed consent. EXCLUSION CRITERIA * Repeated HbA1C \> 10% in the first visit; * Cataract or other eye disease that may interfere with fundus examinations; * Age-related macular degeneration, glaucoma, vitreomacular disease, or other retinal vascular disease, or any ocular condition that, in the opinion of the investigator may affect retinopathy status or alter visual acuity during the study; * Any eye surgery within a period of 6-months; * Previous laser treatment or previous intravitreal injections; * Any patient comorbidity likely to affect the eye and not related with diabetes or cardiovascular disease; * Presence of CIME (CRT ≥ 290 μm in women and ≥ 305 μm in men) with vision loss or needing immediate treatment, according to clinical practice; * Dilatation of the pupil \< 5 mm; * Uncontrolled systemic hypertension (values outside normal range: systolic 70-210 mmHg and diastolic 50-120 mmHg).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CS001 Centre for Clinical Trials - AIBILI
Coimbra, Portugal
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CS020 - G. B. Bietti Eye Foundation - IRCCS
Roma, Italy
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CS042 - Department of Ophthalmology, University Hospital, CHU Dijon
Dijon, France
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CS063 - Excellence Eye Research Centre, University G. d'Annunzio of Chieti-Pescara
Pescara, Italy
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CS067- Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffael, Milan
Milan, Italy
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