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

  • STATUS
    Recruiting
  • days left to enroll
    2
  • participants needed
    102
  • sponsor
    Moser Christophe
Updated on 22 April 2022
blindness
Accepts healthy volunteers

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).

Details
Condition Retinal Disease
Treatment Cellularis version 1 imaging
Clinical Study IdentifierNCT04398394
SponsorMoser Christophe
Last Modified on22 April 2022

Eligibility

Yes No Not Sure

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
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