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

Retinal Detachment Clinical Trial

— CRADO-RED  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02618083
• Other study ID #: ALR_2015_24
• Status: Terminated
• Phase: N/A
• First received: November 26, 2015
• Last updated: February 9, 2018
• Start date: December 28, 2015
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment

Intervention

Device:
• color Doppler ultrasound
pre-operative blood flow velocity measurement with a color Doppler ultrasound device

Locations

Country	Name	City	State
France	Fondation ophtalmique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual acuity measured with the Early Treatment Diabetic Retinopathy Study (ETDRS) scale before surgery and at the sixth :month of follow-up		Six months