- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03655652
Preoperative Progression of Retinal Detachment
August 31, 2018 updated by: Mark Alberti, Glostrup University Hospital, Copenhagen
Preoperative Progression of fovea-on Retinal Detachment
Patients are required to position prior to retinal detachment surgery.
We seek to see whether there is a correlation between the performed positioning and retinal detachment progression/regression in fovea-on retinal detachment patients.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Glostrup, Denmark, 2600
- Recruiting
- Department of Ophthalmology, Rigshospitalet - Glostrup
-
Contact:
- Mark Alberti, MD
- Phone Number: +4551925195
- Email: malb0038@regionh.dk
-
Principal Investigator:
- Mark Alberti, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with a fovea-on retinal detachment referred to Rigshospitalet - Glostrup Department of Ophthalmology.
Description
Inclusion Criteria:
- fovea-on retinal detachment
- informed consent
Exclusion Criteria:
- previous retinal detachment surgery
- >14 days of retinal detachment symptoms
- split-fovea retinal detachment
- other retinal disease with influence on retinal biomechanics/elasticity (proliferative diabetic retinopathy, wet AMD)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retinal detachment progression/regression
Time Frame: 1-72 hours
|
Measured by OCT
|
1-72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positioning
Time Frame: 1-72 hours
|
Measured by device
|
1-72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Anticipated)
February 1, 2019
Study Completion (Anticipated)
October 1, 2019
Study Registration Dates
First Submitted
August 30, 2018
First Submitted That Met QC Criteria
August 30, 2018
First Posted (Actual)
August 31, 2018
Study Record Updates
Last Update Posted (Actual)
September 4, 2018
Last Update Submitted That Met QC Criteria
August 31, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-17015584
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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