Retinitis PigmentosaAOSLO-OCTNCT04620876
Bimodal and Coaxial High Resolution Ophtalmic Imaging
A study testing Bimodal high resolution imaging of the retina in people with Retinitis Pigmentosa and Maculopathy, Age Related, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
Trial summary
The knowledge of the pathogenesis of retinal affections, a major cause of blindness, has greatly benefited from recent advances in retinal imaging. However, optical aberrations of the ocular media limit the resolution that can be achieved by current techniques. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinitis Pigmentosa, Maculopathy, Age Related, Macular Dystrophy
- What is being tested?
- Bimodal high resolution imaging of the retina
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People over 18
- Patient with a pathology affecting the eye or healthy volunteer
- Participant who signed the consent
- Beneficiaries of the health insurance
Who cannot join
- Patients with a history of photosensitivity.
- Patients who have just received a photodynamic therapy treatment
- Patients taking drugs with photosensitivity as a side effect.
- Persons with pacemakers or other implanted electronic medical device
- Patients with viral conjunctivitis or any other infectious disease.
- Patients with skin lesions on the neck or forehead
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- Patients at high risk of damage from optical radiation, such as aphakic patients, or patients with decreased sensitivity to light due to fundus disease.
- Participant unable to be followed throughout the study
- Advanced cataract or severe opacities in the anterior segment of the eye.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75012
Michel Paques, puph, 01 40 02 14 15
About this study
The knowledge of the pathogenesis of retinal affections, a major cause of blindness, has greatly benefited from recent advances in retinal imaging. However, optical aberrations of the ocular media limit the resolution that can be achieved by current techniques.
The use of an adaptive optics system improves the resolution of ophthalmoscopes by several orders of magnitude, allowing the visualization of many retinal microstructures: photoreceptors, vessels, bundles of nerve fibers.
Read more
Recently, the development of the coupling of the two main imaging techniques, the Adaptive Optics Ophthalmoscope with Optical Coherence Tomography, enables unparalleled three-dimensional in vivo cell-scale imaging, while remaining comfortable for the patients.
The purpose of this project is to evaluate the performance of this system for imaging micrometric retinal structures.
Read the detailed description
The goal of the project is the capture and analysis of images with AOSLO system, in order to evaluate the performance of this system compared to OCT imaging devices and existing Adaptive Optics used at National Hospital of Ophthalmology.
- Conditions
- Retinitis Pigmentosa, Maculopathy, Age Related, Macular Dystrophy, Macular Edema, Retinal Detachment, Retinal Degeneration
- Being tested
- Bimodal high resolution imaging of the retina
- Medical subject headings
- Retinitis Pigmentosa, Macular Degeneration, Macular Edema, Retinal Detachment, Retinal Degeneration, Glaucoma, Hypertension, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimodal high resolution imaging of the retinaOther
The protocol consists of performing an Optical coherence tomography and Scanning laser ophthalmoscope system using adaptive optics (AO-SLO-OCT).The participant is asked to put his forehead against the temple supports and his chin on a chin rest. The subject will be asked to fix a test pattern in the form of a cross. The pattern is positioned according to the desired eccentricity with respect to the fovea. The actual acquisition lasts a few seconds, possibly repeated to cover the field of the desired eye. The acquisition protocol depends on the subjects, their pathology and the system used; the area examined will be modified on a case by case basis. The total duration of each exam can be estimated at less than half an hour, with frequent breaks.
| Study group | Role | What they receive |
|---|---|---|
| Bimodal and coaxial high resolution imaging of the retina | Experimental | Optical coherence tomography and Scanning laser ophthalmoscope system using adaptive optics (AO-SLO-OCT) Receives: Other: Bimodal high resolution imaging of the retina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization and image analysis of a structure of interest
The visualization of the structure of interest in at least one area of the image will be considered the main criterion of success.
Measured: From date of inclusion until the date of last documented progression , assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Oct 2019
- Primary completion1 Oct 2023 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies 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
- 1,200 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
- Michel PAQUES, Principal investigator, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620876
- Sponsor's protocol ID
- P16-02
- Other IDs
- 2016-A00704-47
- Acronym
- AOSLO-OCT
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 9 Nov 2020
- 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 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bimodal and Coaxial High Resolution Ophtalmic Imaging
- ClinicalTrials.gov ID
- NCT04620876
- Acronym / sponsor ID
- AOSLO-OCT / P16-02
- Conditions
- Retinitis Pigmentosa, Maculopathy, Age Related, Macular Dystrophy, Macular Edema, Retinal Detachment, Retinal Degeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 9 Nov 2020 (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.
The knowledge of the pathogenesis of retinal affections, a major cause of blindness, has greatly benefited from recent advances in retinal imaging. However, optical aberrations of the ocular media limit the resolution that can be achieved by current techniques.
The use of an adaptive optics system improves the resolution of ophthalmoscopes by several orders of magnitude, allowing the visualization of many retinal microstructures: photoreceptors, vessels, bundles of nerve fibers.
Recently, the development of the coupling of the two main imaging techniques, the Adaptive Optics Ophthalmoscope with Optical Coherence Tomography, enables unparalleled three-dimensional in vivo cell-scale imaging, while remaining comfortable for the patients.
The purpose of this project is to evaluate the performance of this system for imaging micrometric retinal structures.
Detailed description
The goal of the project is the capture and analysis of images with AOSLO system, in order to evaluate the performance of this system compared to OCT imaging devices and existing Adaptive Optics used at National Hospital of Ophthalmology.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bimodal and coaxial high resolution imaging of the retina | Experimental | Other: Bimodal high resolution imaging of the retinaOptical coherence tomography and Scanning laser ophthalmoscope system using adaptive optics (AO-SLO-OCT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People over 18
- Patient with a pathology affecting the eye or healthy volunteer
- Participant who signed the consent
- Beneficiaries of the health insurance
Key exclusion criteria (9 listed)
- Patients with a history of photosensitivity.
- Patients who have just received a photodynamic therapy treatment
- Patients taking drugs with photosensitivity as a side effect.
- Persons with pacemakers or other implanted electronic medical device
- Patients with viral conjunctivitis or any other infectious disease.
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 |
|---|---|---|
| Bimodal high resolution imaging of the retinaThe protocol consists of performing an Optical coherence tomography and Scanning laser ophthalmoscope system using adaptive optics (AO-SLO-OCT).The participant is asked to put his forehead against the temple supports and his chin on a chin rest. The subject will be asked to fix a test pattern in the form of a cross. The pattern is positioned according to the desired eccentricity with respect to the fovea. The actual acquisition lasts a few seconds, possibly repeated to cover the field of the desired eye. The acquisition protocol depends on the subjects, their pathology and the system used; the area examined will be modified on a case by case basis. The total duration of each exam can be estimated at less than half an hour, with frequent breaks. | Other | Bimodal and coaxial high resolution imaging of the retina |
Primary outcome
Visualization and image analysis of a structure of interest
Time frame: From date of inclusion until the date of last documented progression , assessed up to 5 years
The visualization of the structure of interest in at least one area of the image will be considered the main criterion of success.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
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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. This study is not recruiting at the moment.
Michel PAQUES 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 Bimodal high resolution imaging of the retina in people with Retinitis Pigmentosa and Maculopathy, Age Related, 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hayet Serhane (0140021144, hserhane@15-20.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization and image analysis of a structure of interest (time frame: From date of inclusion until the date of last documented progression , assessed up to 5 years). 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 9 Nov 2020.