Imaging of Corneal and Crystalline by Near Infrared Retro-illumination

Not Applicable

Completed

• Conditions: Eye Diseases
• Interventions: Device: Retro-illuminator

• Registration Number: NCT05717543
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-26
• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-08
• Primary Completion: 2023-03-16
• Study Completion: 2023-03-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 384

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with corneal pathology, crystalline pathology, or pigmentary glaucoma	Retro-illuminator	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

Primary Outcome Measures

Name	Time	Method
Percentage of pictures without reflection (%)	Year: 1	Evaluation of the device's retroillumination. Pictures without reflection: no reflection or a minimal reflection without loss of information.

Secondary Outcome Measures

Name	Time	Method
Percentage of pictures clean on the pathological area (%)	Year: 1	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	Year: 1	Number of serious adverse events

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France