NCT05717543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 26, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

January 26, 2023

Last Update Submit

April 25, 2023

Conditions

Eye Diseases

Keywords

pigmentary glaucomacrystalline pathologycorneal pathologyRetroilluminationInfrared

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Percentage of pictures clean on the pathological area (%)

    Year: 1

  • Serious adverse events

    Year: 1

Study Arms (1)

Patient with corneal pathology, crystalline pathology, or pigmentary glaucoma

EXPERIMENTAL

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

Interventions

Retro-illuminatorDEVICE

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

Patient with corneal pathology, crystalline pathology, or pigmentary glaucoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Eye DiseasesGlaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular Hypertension

Study Officials

  • Gilles THURET, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Exploratory pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 8, 2023

Study Start

January 26, 2023

Primary Completion

March 16, 2023

Study Completion

March 16, 2023

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)