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NCT05717543 Clinical Trial

Imaging of Corneal and Crystalline by Near Infrared Retro-illumination

Eye Diseases Clinical Trial

— RETRO-ILLUMI  

Official title:
Imaging of Corneal and Crystalline by Near Infrared Retro-illumination

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05717543
Other study ID # 21CH117
Secondary ID 2021-A01496-35
Status Completed
Phase N/A
First received
Last updated
Start date January 26, 2023
Est. completion date March 16, 2023

Study information
Verified date April 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 nm), and a process which eliminates the reflections.

Recruitment information / eligibility
Status Completed
Enrollment 384
Est. completion date March 16, 2023
Est. primary completion date March 16, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Retro-illuminator
The device Retro-illuminator will be used to photograph the eyes.

Locations
Country Name City State
France CHU Saint-Etienne Saint-Étienne

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of pictures without reflection (%) Evaluation of the device's retroillumination. Pictures without reflection: no reflection or a minimal reflection without loss of information. Year: 1
Secondary 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.. Year: 1
Secondary Serious adverse events Number of serious adverse events Year: 1
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