Glaucoma Associated With Other Ocular DisordersCERES-OTTNCT06976034
oCular Examination at Cell RESolution With Optical TransmissionTomography
A study testing Optical Transmission Tomography (OTT), Optical Coherence Tomography (OCT) and Specular Microscopy (SM) in people with Glaucoma Associated With Other Ocular Disorders, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
Trial summary
Understanding the pathogenesis of eye diseases has benefited greatly from recent advances in ophthalmic imaging. However, current clinical imaging systems, such as optical coherence tomography (OCT), are limited in terms of resolution, acquisition speed or access to certain eye functions. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma Associated With Other Ocular Disorders
- What is being tested?
- Optical Transmission Tomography (OTT), Optical Coherence Tomography (OCT) and Specular Microscopy (SM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2024to 12 Nov 2029
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Patients:
- 200 subjects aged 18 to 80 years;
- Male or female;
- with an ocular disease affecting the cornea, ocular surface, lens (cataract) or glaucoma, or requiring refractive surgery or post-refractive surgery follow-up;
- Are covered by the French Assurance Maladie;
- Have signed an express, free and informed consent form.
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- For Healthy volunteers:
- 100 subjects aged 18 to 80 years;
- Male or female;
- Healthy subjects with no known pathology directly or indirectly affecting ocular structures;
- Covered by the French Assurance Maladie.
- Having signed an express, free and informed consent form.
Who cannot join
- For all participants:
- Inability to hold a still position on a standard ophthalmic chin rest;
- Conjunctivitis or other contagious contact disease in active phase;
- Having an implanted pacemaker or other electronic medical device;
- Having a predisposition to iridocorneal angle closure;
- Vulnerable persons or persons under legal protection (pregnant or breast-feeding women; persons under guardianship,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75012
Nabil BROUK, 00 33 1 40 02 11 44, nbrouk@15-20.fr
Nacim BOUHERAOUA
About this study
Understanding the pathogenesis of eye diseases has benefited greatly from recent advances in ophthalmic imaging. However, current clinical imaging systems, such as optical coherence tomography (OCT), are limited in terms of resolution, acquisition speed or access to certain eye functions. Our team has participated in the development of a new generation of imaging technology known as optical transmission tomography (OTT), which enables imaging of the anterior parts of the eye with high cellular resolution, a wide field of view and reduced examination delay.
Read the detailed description
For healthy subjects: an imaging examination using each system (OTT + OCT + specular microscopy) will be carried out twice, at an interval of two (2) years (inclusion visit + visit at 24 months). Several imaging images will be taken by two different operators during these sessions.
For patients: an imaging examination using each system (OTT + OCT + specular microscopy) will be carried out by two different operators, and several imaging images will be taken. These examinations will be carried out at the inclusion visit and at the following visits according to the disease assessment schedule, lasting up to a maximum of 4 years.
- Being tested
- Optical Transmission Tomography (OTT), Optical Coherence Tomography (OCT), Specular Microscopy (SM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Transmission Tomography (OTT)Device
Multiple imaging sessions added by research using the systems described (OTT) will be carried out by two different operators at different positions during these sessions.
Optical Coherence Tomography (OCT)Device
Multiple imaging sessions (OCT) already used in standard of care will be performed by two different operators at different positions during these sessions.
Specular Microscopy (SM)Device
Multiple imaging sessions (SM) already used in standard of care will be performed by two different operators at different positions during these sessions.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Ocular Disease | Experimental | Patients: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out by two different operators, and several imaging images will be taken from different positions. These examinations will be performed at the inclusion visit and at follow-up visits as part of the usual management of the disease up to a maximum of 4 years Receives: Device: Optical Transmission Tomography (OTT); Device: Optical Coherence Tomography (OCT); Device: Specular Microscopy (SM) |
| Healthy volunteers | Active comparator | Healthy Volunteers: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out twice, at the inclusion visit and at 24 months (2 years), the maximum duration of participation for healthy volunteers. Several imaging sessions will be carried out by two different operators at different positions Receives: Device: Optical Transmission Tomography (OTT); Device: Optical Coherence Tomography (OCT); Device: Specular Microscopy (SM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality
Quality assessed by two blinded experts.
This is an evaluation of image quality in terms of operation according to the following scheme.
Quality assessment:
- Sufficient quality : Yes Or No
If no, tick yes, below and fill in the cause:
Insufficient quality: ☒ yes ☐ no
Cause:
- Technical problem Or
- Patient-related problem (inability to fix, or comply with procedure, etc.)
Measured: between 1 day and 4 years
Endothelial cell density
Assessment of endothelial cell density.
Measured: between 1 day and 4 years
Imaging new corneal and lens structures
corneal and lens structures:measure density in other cell types
Measured: between 1 day and 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start12 Nov 2024
- Primary completion12 Nov 2029 (estimated)
- Study completion12 Nov 2029 (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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, exploratory, longitudinal, non-randomized, single-center study including patients and healthy volunteers.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nacim BOUHERAOUA, PU-PH, Principal investigator, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976034
- Sponsor's protocol ID
- P24-01
- Acronym
- CERES-OTT
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- oCular Examination at Cell RESolution With Optical TransmissionTomography
- ClinicalTrials.gov ID
- NCT06976034
- Acronym / sponsor ID
- CERES-OTT / P24-01
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 12 Nov 2029 (estimated)
- Study completion
- 12 Nov 2029 (estimated)
- First posted
- 16 May 2025 (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.
Understanding the pathogenesis of eye diseases has benefited greatly from recent advances in ophthalmic imaging. However, current clinical imaging systems, such as optical coherence tomography (OCT), are limited in terms of resolution, acquisition speed or access to certain eye functions. Our team has participated in the development of a new generation of imaging technology known as optical transmission tomography (OTT), which enables imaging of the anterior parts of the eye with high cellular resolution, a wide field of view and reduced examination delay.
Detailed description
For healthy subjects: an imaging examination using each system (OTT + OCT + specular microscopy) will be carried out twice, at an interval of two (2) years (inclusion visit + visit at 24 months). Several imaging images will be taken by two different operators during these sessions.
For patients: an imaging examination using each system (OTT + OCT + specular microscopy) will be carried out by two different operators, and several imaging images will be taken. These examinations will be carried out at the inclusion visit and at the following visits according to the disease assessment schedule, lasting up to a maximum of 4 years.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, exploratory, longitudinal, non-randomized, single-center study including patients and healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| Patients with Ocular Disease | Experimental | Device: Optical Transmission Tomography (OTT), Device: Optical Coherence Tomography (OCT), Device: Specular Microscopy (SM)Patients: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out by two different operators, and several imaging images will be taken from different positions. These examinations will be performed at the inclusion visit and at follow-up visits as part of the usual management of the disease up to a maximum of 4 years |
| Healthy volunteers | Active comparator | Device: Optical Transmission Tomography (OTT), Device: Optical Coherence Tomography (OCT), Device: Specular Microscopy (SM)Healthy Volunteers: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out twice, at the inclusion visit and at 24 months (2 years), the maximum duration of participation for healthy volunteers. Several imaging sessions will be carried out by two different operators at different positions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 200 subjects aged 18 to 80 years;
- Male or female;
- with an ocular disease affecting the cornea, ocular surface, lens (cataract) or glaucoma, or requiring refractive surgery or post-refractive surgery follow-up;
- Are covered by the French Assurance Maladie;
- Have signed an express, free and informed consent form.
Key exclusion criteria (6 listed)
- Inability to hold a still position on a standard ophthalmic chin rest;
- Conjunctivitis or other contagious contact disease in active phase;
- Having an implanted pacemaker or other electronic medical device;
- Having a predisposition to iridocorneal angle closure;
- Vulnerable persons or persons under legal protection (pregnant or breast-feeding women; persons under guardianship,
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 |
|---|---|---|
| Optical Transmission Tomography (OTT)Multiple imaging sessions added by research using the systems described (OTT) will be carried out by two different operators at different positions during these sessions. | Device | Healthy volunteers, Patients with Ocular Disease |
| Optical Coherence Tomography (OCT)Multiple imaging sessions (OCT) already used in standard of care will be performed by two different operators at different positions during these sessions. | Device | Healthy volunteers, Patients with Ocular Disease |
| Specular Microscopy (SM)Multiple imaging sessions (SM) already used in standard of care will be performed by two different operators at different positions during these sessions. | Device | Healthy volunteers, Patients with Ocular Disease |
Primary outcome
Image quality
Time frame: between 1 day and 4 years
Quality assessed by two blinded experts. This is an evaluation of image quality in terms of operation according to the following scheme. Quality assessment: - Sufficient quality : Yes Or No If no, tick yes, below and fill in the cause: Insufficient quality: ☒ yes ☐ no Cause: * Technical problem Or * Patient-related problem (inability to fix, or comply with procedure, etc.)
Endothelial cell density
Time frame: between 1 day and 4 years
Assessment of endothelial cell density.
Imaging new corneal and lens structures
Time frame: between 1 day and 4 years
corneal and lens structures:measure density in other cell types
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 16 May 2025.
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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.
Nacim BOUHERAOUA, PU-PH principal investigator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Transmission Tomography (OTT), Optical Coherence Tomography (OCT) and Specular Microscopy (SM) in people with Glaucoma Associated With Other Ocular Disorders, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
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 12 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Nabil BROUK (00 33 1 40 02 11 44, nbrouk@15-20.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality (time frame: between 1 day and 4 years). The study lists 3 primary outcomes in all. 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 16 May 2025.