Back to resultsImaging of Corneal and Crystalline by Near Infrared Retro-illumination (RETRO-ILLUMI)
Primary Purpose
Eye Diseases
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Retro-illuminator
Sponsored by
About this trial
This is an interventional diagnostic trial for Eye Diseases focused on measuring pigmentary glaucoma, crystalline pathology, corneal pathology, Retroillumination, Infrared
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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
Sites / Locations
- CHU Saint-Etienne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with corneal pathology, crystalline pathology, or pigmentary glaucoma
Arm Description
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
Outcomes
Primary Outcome Measures
Percentage of pictures without reflection (%)
Evaluation of the device's retroillumination. Pictures without reflection: no reflection or a minimal reflection without loss of information.
Secondary Outcome Measures
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..
Serious adverse events
Number of serious adverse events
Full Information
NCT ID
NCT05717543
First Posted
January 26, 2023
Last Updated
April 25, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT05717543
Brief Title
Imaging of Corneal and Crystalline by Near Infrared Retro-illumination
Acronym
RETRO-ILLUMI
Official Title
Imaging of Corneal and Crystalline by Near Infrared Retro-illumination
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 26, 2023 (Actual)
Primary Completion Date
March 16, 2023 (Actual)
Study Completion Date
March 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 nm), and a process which eliminates the reflections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases
Keywords
pigmentary glaucoma, crystalline pathology, corneal pathology, Retroillumination, Infrared
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Exploratory pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
384 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with corneal pathology, crystalline pathology, or pigmentary glaucoma
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Retro-illuminator
Intervention Description
The device Retro-illuminator will be used to photograph the eyes.
Primary Outcome Measure Information:
Title
Percentage of pictures without reflection (%)
Description
Evaluation of the device's retroillumination. Pictures without reflection: no reflection or a minimal reflection without loss of information.
Time Frame
Year: 1
Secondary Outcome Measure Information:
Title
Percentage of pictures clean on the pathological area (%)
Description
Evaluation of the device's retroillumination. Pictures clean : absence of blur, or minimal blurred that does not result in loss of information..
Time Frame
Year: 1
Title
Serious adverse events
Description
Number of serious adverse events
Time Frame
Year: 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles THURET, MD PhD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Étienne
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Imaging of Corneal and Crystalline by Near Infrared Retro-illumination
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