Retinal Imaging With Oblique Illumination

Retinal Disease Clinical Trial

— ASSESS  

Official title:

Single Centre Study: Investigational Medical Device of Transscleral Optical Phase Imaging for Retinal Imaging in Healthy Eyes and Retinal Pathology.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04398394
• Other study ID #: 2019-00429
• Status: Completed
• Phase: N/A
• Start date: August 11, 2020
• Est. completion date: April 28, 2022

Study information

• Verified date: July 2023
• Source: Ecole Polytechnique Fédérale de Lausanne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Retinal diseases are the major cause of blindness in industrialized countries and while tremendous effort is made to develop novel therapeutic strategies to rescue retinal cells, optimal means to evaluate the effects of such treatments is still missing. Nowadays, diseases diagnosis and treatment monitoring are performed thanks to imaging devices and functional measurements (visual acuity of visual field tests). These eye examinations lead to the detection of large scale damages of the retinal tissue, i.e. the diagnosis is made too late or the treatments cannot be adapted in time. With the developed technology, the goal is to provide a tool to the ophthalmologists that allow for better treatment monitoring and early diagnosis. Indeed, the technology is able to image the retinal tissues with a ten times more detailed visualization as compared to the standard of care (OCT instruments, SLO instruments or eye fundus cameras). Towards this goal, we designed the present protocol in order to test the technology with a clinical prototype (Cellularis version 1) in a clinical environment. The objective is to describe and quantify at the cellular level the retina of patient affected by different retinal diseases as well as the healthy retina of people with different ages. We will assess the repeatability of the instrument and compare the results of the measurements with images obtained with the standard of care (OCT and SLO images).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 28, 2022
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Group 1

• Individuals, 18 to 50 yo, with normal eye fundus.

• Emmetropic or ametropic between +3D and -3D

Group 2

• Individuals, 18 to 50 yo, with normal eye fundus.

• Myopic between -6D and -12D.

Group 3

• Individuals over the age of 50 and age-matched to patients with AMD.

• With nwith normal eye fundus.

• Astigmatic, myopic (<-12D) or presbyopic participants may be included

Group 4

• Patient over 50 yo, with early or intermediate AMD, including extrafoveolar geographic atrophy

• with visual acuity = 0.6 and clinical judgment of good central fixation.

Group 5

• Patient over 18, with other retinopathy than AMD,

• with visual acuity = 0.6 and nd clinical judgment of good fixation

Exclusion Criteria:

Eye with

• RPE detachment

• a clinically unclear situation

• abnormality preventing good visualization of the fundus

• less than 3 months post-surgery of the anterior segment

• less than 6 months post-surgery of the posterior segment

• active uveitis - myopia =12D, hyperopia > +5D, astigmatism > 4D

• contraindication to dilatation

• a palpebral opening that is less than 6 mm in height

Individual:

• albino - unable to fix a target at least 10 seconds

• who does not tolerate being in the dark for 30 minutes

• unable to follow the procedures of the study

• refusing to be informed of the incidental discovery of a clinically significant pathology Investigators of the study, their family members, collaborators and students

Related Conditions & MeSH terms

• Retinal Disease
• Retinal Diseases

Intervention

Device:
• Cellularis version 1 imaging
Using a new modality for retinal cell imaging, we aim at comparing qualitatively and quantitatively, the morphology of the deepest layer of the retina, the retinal pigment epithelium (RPE) by imaging the people with a prototype instrument (Cellularis version 1).

Locations

Country	Name	City	State
Switzerland	Jules Gonin eye hospital	Lausanne

Sponsors (3)

Lead Sponsor	Collaborator
Moser Christophe	Eye Hospital Jules Gonin, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Kowalczuk L, Dornier R, Kunzi M, Iskandar A, Misutkova Z, Gryczka A, Navarro A, Jeunet F, Mantel I, Behar-Cohen F, Laforest T, Moser C. In Vivo Retinal Pigment Epithelium Imaging using Transscleral Optical Imaging in Healthy Eyes. Ophthalmol Sci. 2022 Oct — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number RPE [#/mm2]	The primary outcome is the RPE cells density map of the imaged regions (in #/mm2).	2 months
Primary	Qualitative analysis [unitless]	Together with the quantitative outcomes of the density, a detailed qualitative analysis will also be performed.	2 months
Secondary	averaged RPE cell area [um2]	- The RPE cell area.	2 months
Secondary	Averaged number of neighbors of RPE cells [unitless]	Averaged number of neighbors of RPE cells	2 months
Secondary	Averaged RPE spacing [um]	The averaged RPE spacing in um.	2 months
Secondary	Averaged RPE pigmentation parameter [unitless]	RPE pigmentation parameter at cellular level	2 months

External Links

•   Laforest, T., Künzi, M., Kowalczuk, L. et al. Transscleral optical phase imaging of the human retina. Nat. Photonics (2020).