Retinal DetachmentCRADO-REDNCT02618083
Prognostic Value of Hemodynamic Disturbances in Rhegmatogenous Retinal Detachment (CRADO-RED)
A study testing color Doppler ultrasound in people with Retinal Detachment, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- color Doppler ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 28 Dec 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- absence of affiliation to the social security
- eye's axial length> 25.5 mm
- preoperative visual acuity greater than 70/100
- no surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Retinal Detachment
- Being tested
- color Doppler ultrasound
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
color Doppler ultrasoundDevice
pre-operative blood flow velocity measurement with a color Doppler ultrasound device
| Study group | Role | What they receive |
|---|---|---|
| retinal detachment | Experimental | color Doppler ultrasound of the eye Receives: Device: color Doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity measured with the Early Treatment Diabetic Retinopathy Study (ETDRS) scale before surgery and at the sixth week of follow-up
Measured: 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
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start28 Dec 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618083
- Sponsor's protocol ID
- ALR_2015_24
- Acronym
- CRADO-RED
- Status last verified
- Jan 2018
- First submitted
- 26 Nov 2015
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Hemodynamic Disturbances of the Central Retinal Artery in Color Doppler Ultrasound in Rhegmatogenous Retinal Detachment
- ClinicalTrials.gov ID
- NCT02618083
- Acronym / sponsor ID
- CRADO-RED / ALR_2015_24
- Conditions
- Retinal Detachment
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 28 Dec 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| retinal detachment | Experimental | Device: color Doppler ultrasoundcolor Doppler ultrasound of the eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| color Doppler ultrasoundpre-operative blood flow velocity measurement with a color Doppler ultrasound device | Device | retinal detachment |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing color Doppler ultrasound in people with Retinal Detachment, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.