NCT07725055

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Sep 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

Same day

First QC Date

July 21, 2026

Last Update Submit

July 21, 2026

Conditions

Retina DisorderGlaucoma Associated With Other Ocular Disorders

Keywords

RETION

Outcome Measures

Primary Outcomes (1)

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

    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).

    48 months

Study Arms (1)

MONA imaging system

EXPERIMENTAL

acquisition mode with MONA imaging system

Device: MONA Imaging System

Interventions

MONA Imaging SystemDEVICE

acquisition mode with mona system

MONA imaging system

Eligibility Criteria

Age10 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients:
  • subjects aged 10 to 79 years with a condition that may affect the inner retina (e.g., glaucoma, optic neuropathy, etc.)
  • 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:
  • subjects aged over 50 and under 80
  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 24, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

April 1, 2030

Last Updated

July 24, 2026

Record last verified: 2026-07