NCT02618083

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

November 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

December 28, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 12, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

November 26, 2015

Last Update Submit

February 9, 2018

Conditions

Retinal Detachment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Six months

Study Arms (1)

retinal detachment

EXPERIMENTAL

color Doppler ultrasound of the eye

Device: color Doppler ultrasound

Interventions

color Doppler ultrasoundDEVICE

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

retinal detachment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation ophtalmique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2015

First Posted

December 1, 2015

Study Start

December 28, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

February 12, 2018

Record last verified: 2018-01

Locations

FR(1)