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

Primary Purpose

Retinal Detachment

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
color Doppler ultrasound
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Retinal Detachment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondation ophtalmique Adolphe de Rothschild

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

retinal detachment

Arm Description

color Doppler ultrasound of the eye

Outcomes

Primary Outcome Measures

Visual acuity measured with the Early Treatment Diabetic Retinopathy Study (ETDRS) scale before surgery and at the sixth week of follow-up

Secondary Outcome Measures

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

Full Information

First Posted
November 26, 2015
Last Updated
February 9, 2018
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02618083
Brief Title
Prognostic Value of Hemodynamic Disturbances in Rhegmatogenous Retinal Detachment (CRADO-RED)
Acronym
CRADO-RED
Official Title
Prognostic Value of Hemodynamic Disturbances of the Central Retinal Artery in Color Doppler Ultrasound in Rhegmatogenous Retinal Detachment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Study Start Date
December 28, 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
retinal detachment
Arm Type
Experimental
Arm Description
color Doppler ultrasound of the eye
Intervention Type
Device
Intervention Name(s)
color Doppler ultrasound
Intervention Description
pre-operative blood flow velocity measurement with a color Doppler ultrasound device
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fondation ophtalmique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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