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Not yet recruitingNCT07725055RETIONUpdated Jul 24, 2026

AOSLO Imaging for the Study of Cellular Alterations in Retinal Neurodegeneration

An interventional study of MONA Imaging System in Glaucoma Associated With Other Ocular Disorders and Retina Disorder, sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts. Not yet recruiting. Open to participants aged 10 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
260
Allocation
Not applicable
Ages
10 Years to 79 Years
Sex
All
01

Study 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.
Read the 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.
02

Conditions studied

  • Glaucoma Associated With Other Ocular Disorders
  • Retina Disorder

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Keywords

  • RETION
03

In context

Retinal Diseases

333 studies on the registry are indexed under Retinal Diseases; 60 are open to participants now.

This study's planned enrollment of 260 is above the median of 52 across 207 interventional studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts is the lead sponsor of 28 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
260 participants (estimated)

Study arms

  • Experimental
    MONA imaging system

    acquisition mode with MONA imaging system

    Device: MONA Imaging System

Interventions

  • DeviceMONA Imaging System

    acquisition mode with mona system

06

What researchers measure

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).

    Time frame: 48 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07725055
Lead sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Responsible party
Sponsor
First posted
Jul 24, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Apr 2030 (estimated)
Last update
Jul 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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