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Clinical Trials/NCT04398394
NCT04398394
Completed
Not Applicable

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

Moser Christophe1 site in 1 country102 target enrollmentAugust 11, 2020
ConditionsRetinal Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Retinal Disease
Sponsor
Moser Christophe
Enrollment
102
Locations
1
Primary Endpoint
Number RPE [#/mm2]
Status
Completed
Last Updated
2 years ago

Overview

Brief 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).

Registry
clinicaltrials.gov
Start Date
August 11, 2020
End Date
April 28, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Moser Christophe
Responsible Party
Sponsor Investigator
Principal Investigator

Moser Christophe

Professor

Ecole Polytechnique Fédérale de Lausanne

Eligibility Criteria

Inclusion Criteria

  • Individuals, 18 to 50 yo, with normal eye fundus.
  • Emmetropic or ametropic between +3D and -3D
  • Individuals, 18 to 50 yo, with normal eye fundus.
  • Myopic between -6D and -12D.
  • 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
  • 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.
  • Patient over 18, with other retinopathy than AMD,

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Number RPE [#/mm2]

Time Frame: 2 months

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

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

  • averaged RPE cell area [um2](2 months)
  • Averaged number of neighbors of RPE cells [unitless](2 months)
  • Averaged RPE pigmentation parameter [unitless](2 months)
  • Averaged RPE spacing [um](2 months)

Study Sites (1)

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