NCT04128150

Brief Summary

To increase the clinical experience of using the rtx1 camera in various retinal disorders and to follow the evolution of structural alterations during retinal diseases using adaptive optics imaging with the rtx1 camera

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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

Study Start

First participant enrolled

January 17, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

5 years

First QC Date

October 14, 2019

Last Update Submit

October 14, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evolution of retina diseases

    Increase the clinical experience of using the rtx1 camera in various conditions with retinal impact

    From date of inclusion until the date of last documented progression , assessed up to 5 years

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pathologies affecting photoreceptors and the retinal vessels

You may qualify if:

  • Persons over 12 years of age, of both sexes, presenting with retinal pathologies.
  • Beneficiaries of the health insurance

You may not qualify if:

  • Any abnormality preventing good quality OA imaging on both eyes
  • Major under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Lariboisière

Paris, 75010, France

NOT YET RECRUITING

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, 75012, France

RECRUITING

Hôpital Pitié-Salpétrière

Paris, 75013, France

NOT YET RECRUITING

Related Publications (1)

  • Paques M, Norberg N, Chaumette C, Sennlaub F, Rossi E, Borella Y, Grieve K. Long Term Time-Lapse Imaging of Geographic Atrophy: A Pilot Study. Front Med (Lausanne). 2022 Jun 22;9:868163. doi: 10.3389/fmed.2022.868163. eCollection 2022.

MeSH Terms

Conditions

Retinitis PigmentosaMacular DegenerationMacular EdemaRetinal DegenerationDiabetic RetinopathyRetinal Vein OcclusionHypertension

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesVenous ThrombosisThrombosisEmbolism and Thrombosis

Study Officials

  • Michel PAQUES

    Centre Hospitalier National d'Ophtalmologie des Quinze-Vints

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 16, 2019

Study Start

January 17, 2018

Primary Completion

January 30, 2023

Study Completion

January 30, 2024

Last Updated

October 16, 2019

Record last verified: 2019-10

Locations