Tomography, Optical CoherenceODIGITNCT03326908
Description of the Interdigitation Retinal Area by SD-OCT: An Exploratory Study
A study testing Spectral Domain Optical Coherence Tomography in people with Tomography, Optical Coherence and Retina, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Improvement of retinal medical imaging opens new perspectives for exploring the retinal structures. Optical coherence spectral domain (SD-OCT), which has been widely used in the last ten years, is certainly the most advanced device. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tomography, Optical Coherence, Retina
- What is being tested?
- Spectral Domain Optical Coherence Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2017to 24 Jan 2018
- 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
- Patient aged 18 years or older
- Consent to participate
Who cannot join
- Retinal abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Description of the Interdigitation Retinal Area by SD-OCT (Spectral Domain Optical Coherence Tomography): An Exploratory Study (ODIGIT)
Improvement of retinal medical imaging opens new perspectives for exploring the retinal structures. Optical coherence spectral domain (SD-OCT), which has been widely used in the last ten years, is certainly the most advanced device. In the analysis of patients without retinal disease using SD-OCT, granulations in the interdigitation area were observed. These granulations have never been described with this device. They could correspond either to the degradation products of the external segments of the photoreceptors or to melanosomes. A descriptive study of these granulations at different examination times and in different lighting situations would allow us to obtain essential information for a better understanding of this area. Based on the results, larger studies could explore this area more finely in retinal pathologies involving dysfunctions of photoreceptors or of the pigmentary epithelium.
- Conditions
- Tomography, Optical Coherence, Retina
- Being tested
- Spectral Domain Optical Coherence Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectral Domain Optical Coherence TomographyDevice
Five SD-OCTs will be performed with various conditions of enlightenment.
| Study group | Role | What they receive |
|---|---|---|
| Normal conditions of light exposure | Other | Spectral Domain Optical Coherence Tomography (SD-OCT):
Five SD-OCTs will be produced under the same lighting conditions (photopic).
* At baseline
* 20 minutes after baseline
* 25 minutes after baseline
* 45 minutes after baseline
* 60 minutes after baseline Receives: Device: Spectral Domain Optical Coherence Tomography |
| Light variations | Other | Spectral Domain Optical Coherence Tomography (SD-OCT):
Five SD-OCT will be performed:
* at baseline, in a room with photopic artificial lighting (400 lux)
* after a period of adaptation to the dark (20 minutes in the dark: 0 lux)
* after 5 min of retinal glare, obtained by means of a projection of light of 1000 lux on the fundus of eye
* 15 minutes after this period of retinal glare, in photopic artificial lighting
* 30 minutes after the period of retinal glare, in photopic artificial lighting Receives: Device: Spectral Domain Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the number of hyperreflective granulations in the interdigitation area according to time and enlightenment
Measured: 1 hour after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start12 Oct 2017
- Primary completion10 Jan 2018
- Study completion24 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tomography, Optical CoherenceStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326908
- Sponsor's protocol ID
- MMT_2017_16
- Acronym
- ODIGIT
- Status last verified
- Jan 2018
- First submitted
- 27 Oct 2017
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mathis T, Vasseur V, Zuber K, Arej N, Loria O, Kodjikian L, Sennlaub F, Mauget-Faysse M. Light-induced modifications of the outer retinal hyperreflective layers on spectral-domain optical coherence tomography in humans: an experimental study. Acta Ophthalmol. 2021 Nov;99(7):765-772. doi: 10.1111/aos.14723. Epub 2021 Jan 4.
PubMed 33393736
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Interdigitation Retinal Area by SD-OCT (Spectral Domain Optical Coherence Tomography): An Exploratory Study (ODIGIT)
- ClinicalTrials.gov ID
- NCT03326908
- Acronym / sponsor ID
- ODIGIT / MMT_2017_16
- Conditions
- Tomography, Optical Coherence, Retina
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 31 Oct 2017 (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.
Improvement of retinal medical imaging opens new perspectives for exploring the retinal structures. Optical coherence spectral domain (SD-OCT), which has been widely used in the last ten years, is certainly the most advanced device. In the analysis of patients without retinal disease using SD-OCT, granulations in the interdigitation area were observed. These granulations have never been described with this device. They could correspond either to the degradation products of the external segments of the photoreceptors or to melanosomes. A descriptive study of these granulations at different examination times and in different lighting situations would allow us to obtain essential information for a better understanding of this area. Based on the results, larger studies could explore this area more finely in retinal pathologies involving dysfunctions of photoreceptors or of the pigmentary epithelium.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal conditions of light exposure | Other | Device: Spectral Domain Optical Coherence TomographySpectral Domain Optical Coherence Tomography (SD-OCT): Five SD-OCTs will be produced under the same lighting conditions (photopic). * At baseline * 20 minutes after baseline * 25 minutes after baseline * 45 minutes after baseline * 60 minutes after baseline |
| Light variations | Other | Device: Spectral Domain Optical Coherence TomographySpectral Domain Optical Coherence Tomography (SD-OCT): Five SD-OCT will be performed: * at baseline, in a room with photopic artificial lighting (400 lux) * after a period of adaptation to the dark (20 minutes in the dark: 0 lux) * after 5 min of retinal glare, obtained by means of a projection of light of 1000 lux on the fundus of eye * 15 minutes after this period of retinal glare, in photopic artificial lighting * 30 minutes after the period of retinal glare, in photopic artificial lighting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient aged 18 years or older
- Consent to participate
Key exclusion criteria (1 listed)
- Retinal abnormalities
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 |
|---|---|---|
| Spectral Domain Optical Coherence TomographyFive SD-OCTs will be performed with various conditions of enlightenment. | Device | Light variations, Normal conditions of light exposure |
Primary outcome
Variation of the number of hyperreflective granulations in the interdigitation area according to time and enlightenment
Time frame: 1 hour after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Results publication: PubMed 33393736Mathis T, Vasseur V, Zuber K, Arej N, Loria O, Kodjikian L, Sennlaub F, Mauget-Faysse M. Light-induced modifications of the outer retinal hyperreflective layers on spectral-domain optical coherence tomography in humans: an experimental study. Acta Ophthalmol. 2021 Nov;99(7):765-772. doi: 10.1111/aos.14723. Epub 2021 Jan 4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectral Domain Optical Coherence Tomography in people with Tomography, Optical Coherence and Retina, run by Fondation Ophtalmologique Adolphe de Rothschild 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Variation of the number of hyperreflective granulations in the interdigitation area according to time and enlightenment (time frame: 1 hour after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03326908, which also lists 1 linked publication.
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 6 Jan 2026.