Prognostic Value of Hemodynamic Disturbances in Rhegmatogenous Retinal Detachment (CRADO-RED) (CRADO-RED)

February 9, 2018 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Prognostic Value of Hemodynamic Disturbances of the Central Retinal Artery in Color Doppler Ultrasound in Rhegmatogenous Retinal Detachment

Retinal detachments correspond to a separation of the neuroepithelium from the pigment epithelium. They can be exudative (sometimes in conjunction with a tumor), tractional, traumatic (postoperative) or rhegmatogenous (in relation to a tear).

Ultrasound, requested when the fundus is difficult to achieve and shows a hyperechoic mobile membrane. It can also measure the hemodynamic parameters of retinal arteries.

A preliminary study showed a correlation between systolic velocity in the central retinal artery and postoperative visual acuity.

The aim of this study is to confirm those preliminary data.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation ophtalmique Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over 18 years
  • rhegmatogenous retinal detachment, relapsing or not, including pseudophakic retinal detachment or aphakic retinal detachment, if the retinal detachment occurs more than three months after phacoemulsification

Exclusion Criteria:

  • traumatic retinal detachment
  • bilateral retinal detachment
  • less than 3 months after phakoemulsification
  • predictable follow-up of less than 6 months
  • patient under of legal protection
  • patient's opposition to participate
  • absence of affiliation to the social security
  • eye's axial length> 25.5 mm
  • preoperative visual acuity greater than 70/100
  • no surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: retinal detachment
color Doppler ultrasound of the eye
Device: color Doppler ultrasound
pre-operative blood flow velocity measurement with a color Doppler ultrasound device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity measured with the Early Treatment Diabetic Retinopathy Study (ETDRS) scale before surgery and at the sixth week of follow-up
Time Frame: Six weeks
Six weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual acuity measured with the Early Treatment Diabetic Retinopathy Study (ETDRS) scale before surgery and at the sixth :month of follow-up
Time Frame: Six months
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

November 26, 2015

First Submitted That Met QC Criteria

November 26, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Actual)

February 12, 2018

Last Update Submitted That Met QC Criteria

February 9, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALR_2015_24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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