Menu
Not yet recruiting NCT07725055

AOSLO Imaging for the Study of Cellular Alterations in Retinal Neurodegeneration

No phase Interventional Glaucoma Associated With Other Ocular Disorders Retina Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MONA Imaging System.
Who it may be relevant to
Registry conditions: Glaucoma Associated With Other Ocular Disorders, Retina Disorder. Basic parameters: 10 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Device MONA Imaging System
    acquisition mode with mona system

Primary outcome measures

  • Proportion of images obtained with the MONA system deemed usable for the analysis of retinal microstructures. [Time frame: 48 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07725055 · P26-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗