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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT05717543

Collaborator

(none)

384

Enrollment

Location

Arm

9.2

Anticipated Duration (Months)

41.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases	Device: Retro-illuminator	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

384 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Exploratory pilot studyExploratory pilot study

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Imaging of Corneal and Crystalline by Near Infrared Retro-illumination

Actual Study Start Date :

Jan 26, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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