Glaucoma Associated With Other Ocular DisordersRETIONNCT07725055
AOSLO Imaging for the Study of Cellular Alterations in Retinal Neurodegeneration
A study testing MONA Imaging System in people with Glaucoma Associated With Other Ocular Disorders and Retina Disorder, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
Trial 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 more about this study
- Who is it for?
- Ages 10 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma Associated With Other Ocular Disorders, Retina Disorder
- What is being tested?
- MONA Imaging System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 79 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- 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.
About this study
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.
- Being tested
- MONA Imaging System
- Keywords
- RETION
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MONA Imaging SystemDevice
acquisition mode with mona system
| Study group | Role | What they receive |
|---|---|---|
| MONA imaging system | Experimental | acquisition mode with MONA imaging system Receives: Device: MONA Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma Associated With Other Ocular DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725055
- Sponsor's protocol ID
- P26-01
- Acronym
- RETION
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AOSLO Imaging for the Study of Cellular Alterations in Retinal Neurodegeneration
- ClinicalTrials.gov ID
- NCT07725055
- Acronym / sponsor ID
- RETION / P26-01
- Keywords
- RETION
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MONA imaging system | Experimental | Device: MONA Imaging Systemacquisition mode with MONA imaging system |
Who may qualify
- Ages
- 10 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- 30 subjects aged over 50 and under 80
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MONA Imaging Systemacquisition mode with mona system | Device | MONA imaging system |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MONA Imaging System in people with Glaucoma Associated With Other Ocular Disorders and Retina Disorder, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of images obtained with the MONA system deemed usable for the analysis of retinal microstructures. (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.