Eye DiseasesRETRO-ILLUMINCT05717543
Imaging of Corneal and Crystalline by Near Infrared Retro-illumination
A study testing Retro-illuminator in people with Eye Diseases, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Retroillumination photography is difficult. The reflections on the cornea and the lens are constant and prevent from obtaining a complete and clear image. Study team have modified a slit lamp intended to photograph the anterior segment of the eye in retroillumination by using a light source in the near infrared (780… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Diseases
- What is being tested?
- Retro-illuminator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2023to 16 Mar 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with corneal pathology, crystalline pathology, or pigmentary glaucoma with transilluminable iris. In case of bilateral disease, both eyes will be photographed
- Patient having received an instillation of eye drops to dilate the pupil of the eye to be photographed (or of both eyes).
Who cannot join
- Major blepharospasm
- Poor or no pupillary dilation: patient with allergy or intolerance to eye drops used for pupillary dilation, refusal of pupillary dilation
- Pregnant or breastfeeding patient
- Person under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Retroillumination photography is difficult. The reflections on the cornea and the lens are constant and prevent from obtaining a complete and clear image. Study team have modified a slit lamp intended to photograph the anterior segment of the eye in retroillumination by using a light source in the near infrared (780 nm), and a process which eliminates the reflections.
- Conditions
- Eye Diseases
- Being tested
- Retro-illuminator
- Keywords
- pigmentary glaucoma, crystalline pathology, corneal pathology, Retroillumination, Infrared
- Medical subject headings
- Eye Diseases, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retro-illuminatorDevice
The device Retro-illuminator will be used to photograph the eyes.
| Study group | Role | What they receive |
|---|---|---|
| Patient with corneal pathology, crystalline pathology, or pigmentary glaucoma | Experimental | Patient with corneal pathology, crystalline pathology, or pigmentary glaucoma will be included.
Imaging by retroillumination will be realized. In case of bilateral disease, both eyes will be photographed Receives: Device: Retro-illuminator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pictures without reflection (%)
Evaluation of the device's retroillumination. Pictures without reflection: no reflection or a minimal reflection without loss of information.
Measured: Year: 1
Secondary outcomes (2)
Percentage of pictures clean on the pathological area (%)
Evaluation of the device's retroillumination. Pictures clean : absence of blur, or minimal blurred that does not result in loss of information..
Measured: Year: 1
Serious adverse events
Number of serious adverse events
Measured: Year: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start26 Jan 2023
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Exploratory pilot study
- Masking
- None (open label)
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles THURET, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717543
- Sponsor's protocol ID
- 21CH117
- Other IDs
- 2021-A01496-35
- Acronym
- RETRO-ILLUMI
- Status last verified
- Apr 2023
- First submitted
- 26 Jan 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Corneal and Crystalline by Near Infrared Retro-illumination
- ClinicalTrials.gov ID
- NCT05717543
- Acronym / sponsor ID
- RETRO-ILLUMI / 21CH117
- Conditions
- Eye Diseases
- Keywords
- pigmentary glaucoma, crystalline pathology, corneal pathology, Retroillumination, Infrared
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 8 Feb 2023 (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.
Retroillumination photography is difficult. The reflections on the cornea and the lens are constant and prevent from obtaining a complete and clear image. Study team have modified a slit lamp intended to photograph the anterior segment of the eye in retroillumination by using a light source in the near infrared (780 nm), and a process which eliminates the reflections.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exploratory pilot study
| Arm | Type | Receives |
|---|---|---|
| Patient with corneal pathology, crystalline pathology, or pigmentary glaucoma | Experimental | Device: Retro-illuminatorPatient with corneal pathology, crystalline pathology, or pigmentary glaucoma will be included. Imaging by retroillumination will be realized. In case of bilateral disease, both eyes will be photographed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with corneal pathology, crystalline pathology, or pigmentary glaucoma with transilluminable iris. In case of bilateral disease, both eyes will be photographed
- Patient having received an instillation of eye drops to dilate the pupil of the eye to be photographed (or of both eyes).
Key exclusion criteria (4 listed)
- Major blepharospasm
- Poor or no pupillary dilation: patient with allergy or intolerance to eye drops used for pupillary dilation, refusal of pupillary dilation
- Pregnant or breastfeeding patient
- Person under legal protection
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 |
|---|---|---|
| Retro-illuminatorThe device Retro-illuminator will be used to photograph the eyes. | Device | Patient with corneal pathology, crystalline pathology, or pigmentary glaucoma |
Primary outcome
Percentage of pictures without reflection (%)
Time frame: Year: 1
Evaluation of the device's retroillumination. Pictures without reflection: no reflection or a minimal reflection without loss of information.
2 secondary outcomes
Percentage of pictures clean on the pathological area (%)
Time frame: Year: 1
Serious adverse events
Time frame: Year: 1
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 26 Apr 2023.
- 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.
Gilles THURET, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retro-illuminator in people with Eye Diseases, run by Centre Hospitalier Universitaire de Saint Etienne 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 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: finished, as of the sponsor's last update on 26 Apr 2023. 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?
Percentage of pictures without reflection (%) (time frame: Year: 1). 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 26 Apr 2023.