AOSLO Imaging for the Study of Cellular Alterations in Retinal Neurodegeneration

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.

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Key information

Conditions

Glaucoma Associated With Other Ocular Disorders Eye Diseases Retina Disorder Retinal Diseases

Age range

10 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MONA Imaging System

Device

acquisition mode with mona system

Primary outcomes

Proportion of images obtained with the MONA system deemed usable for the analysis of retinal microstructures.

Time frame: 48 months
Images 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).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Other

Registry information

Acronym: RETION

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2030
First posted: Jul 24, 2026
Registry last updated: Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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