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Completed

NCT Number: NCT04398394

Retinal Imaging With Oblique Illumination

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).

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Key information

Conditions

Retinal Disease Eye Diseases Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jules Gonin eye hospital

Lausanne, 1015, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cellularis version 1 imaging

Device

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).

Primary outcomes

  1. Number RPE [#/mm2]

    Time frame: 2 months

    The primary outcome is the RPE cells density map of the imaged regions (in #/mm2).

  2. Qualitative analysis [unitless]

    Time frame: 2 months

    Together with the quantitative outcomes of the density, a detailed qualitative analysis will also be performed.

Secondary outcomes

  1. averaged RPE cell area [um2]

    Time frame: 2 months

    • The RPE cell area.

  2. Averaged number of neighbors of RPE cells [unitless]

    Time frame: 2 months

    Averaged number of neighbors of RPE cells

  3. Averaged RPE spacing [um]

    Time frame: 2 months

    The averaged RPE spacing in um.

  4. Averaged RPE pigmentation parameter [unitless]

    Time frame: 2 months

    RPE pigmentation parameter at cellular level

Sponsors and collaborators

Lead sponsor

Moser Christophe

Other

Collaborators

  • Eye Hospital Jules Gonin
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

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

Acronym: ASSESS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 21, 2020
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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