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

Not Applicable

Terminated

• Conditions: Retinal Detachment
• Interventions: Device: color Doppler ultrasound

• Registration Number: NCT02618083
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-26
• Study First Submitted QC: 2015-11-26
• Study First Posted: 2015-12-01
• Study Start: 2015-12-28
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-02-09
• Last Update Posted: 2018-02-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
retinal detachment	color Doppler ultrasound	color Doppler ultrasound of the eye

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fondation ophtalmique Adolphe de Rothschild; 🇫🇷 Paris, France