Imaging of Corneal and Crystalline by Near Infrared Retro-illumination (RETRO-ILLUMI)

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 Overview

• Status: Completed
• Conditions: Eye Diseases
• Intervention / Treatment: Device: Retro-illuminator

• Study Type: Interventional
• Enrollment (Actual): 384
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with corneal pathology, crystalline pathology, or pigmentary glaucoma; 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	Device: Retro-illuminator; The device Retro-illuminator will be used to photograph the eyes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Serious adverse events	Number of serious adverse events	Year: 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2023
• Primary Completion (Actual): March 16, 2023
• Study Completion (Actual): March 16, 2023

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: pigmentary glaucoma; Infrared; crystalline pathology; corneal pathology; Retroillumination
• Additional Relevant MeSH Terms: Eye Diseases
• Other Study ID Numbers: 21CH117; 2021-A01496-35 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No