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AOSLO Imaging for the Study of Cellular Alterations in Retinal Neurodegeneration

AOSLO Imaging for the Study of Cellular Alterations in Retinal Neurodegeneration

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07725055
Acronym
RETION
Enrollment
260
Registered
2026-07-24
Start date
2026-09-01
Completion date
2030-04-01
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma Associated With Other Ocular Disorders, Retina Disorder

Keywords

RETION

Brief summary

Primary objective: \- Acquisition and analysis of images for non-medical purposes using the MONA IV system, an adaptive-optics-corrected scanning ophthalmoscope. Secondary objectives: * To measure the reproducibility of assessments; * To evaluate the detection of progressive changes.

Detailed description

Patients: * 100 subjects aged 10 to 79 years with a condition that may affect the inner retina (e.g., glaucoma, optic neuropathy, etc.) * 100 subjects aged 10 to 80 years with a condition that may affect the outer retina (e.g., AMD, retinitis pigmentosa, etc.) * Male or female * Covered by health insurance Healthy volunteers: * 30 subjects aged over 50 and under 80 * 30 subjects aged over 18 and under 50 * Male or female * Healthy subjects with no known condition that directly or indirectly affects the structure of the eye * Covered by health insurance For all subjects: * Inability to remain motionless on a standard ophthalmic chin rest. RETION\_Protocol\_v2.0 dated June 10, 2026\_IDRCB: 2026-A00324-47 Page 10 of 44 * Subjects taking medications or suffering from a medical condition that could interfere with the evaluations planned under the protocol; * Participants allergic to tropicamide in cases where pupil dilation is required.

Interventions

DEVICEMONA Imaging System

acquisition mode with mona system

Sponsors

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 79 Years
Healthy volunteers
Yes

Inclusion criteria

Patients: * 100 subjects aged 10 to 79 years with a condition that may affect the inner retina (e.g., glaucoma, optic neuropathy, etc.) * 100 subjects aged 10 to 80 years with a condition that may affect the outer retina (e.g., AMD, retinitis pigmentosa, etc.) * Male or female * Covered by health insurance Healthy volunteers: * 30 subjects aged over 50 and under 80 * 30 subjects aged over 18 and under 50 * Male or female * Healthy subjects with no known condition that directly or indirectly affects the structure of the eye * Covered by health insurance

Exclusion criteria

For all subjects: * Inability to remain motionless on a standard ophthalmic chin rest. RETION\_Protocol\_v2.0 dated June 10, 2026\_IDRCB: 2026-A00324-47 Page 10 of 44 * Subjects taking medications or suffering from a medical condition that could interfere with the evaluations planned under the protocol; * Participants allergic to tropicamide in cases where pupil dilation is required. ☞ Wearing glasses or contact lenses to correct a refractive error is not considered an exclusion criterion.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of images obtained with the MONA system deemed usable for the analysis of retinal microstructures.48 monthsImages are considered usable if they allow for: * visualization of retinal microstructures (yes/no); * measurement of cell density (yes/no); * measurement of vascular diameter (yes/no).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026