Retinal DetachmentNCT03655652
Preoperative Progression of Retinal Detachment
An observational study of Retinal Detachment, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2018to 1 Oct 2019
- Phase
- Observational
- 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
Study population: Patients with a fovea-on retinal detachment referred to Rigshospitalet - Glostrup Department of Ophthalmology.
Who may be able to join
- fovea-on retinal detachment
- informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Morten la Cour, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Rigshospitalet - Glostrup
Glostrup Municipality, 2600
Mark Alberti, MD, +4551925195, malb0038@regionh.dk
Mark Alberti, MD
About this study
Official title: 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.
- Conditions
- Retinal Detachment
- Keywords
- positioning
- Medical subject headings
- Retinal Detachment
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal detachment progression/regression
Measured by OCT
Measured: 1-72 hours
Secondary outcomes (1)
Positioning
Measured by device
Measured: 1-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Feb 2018
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Mark Alberti, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655652
- Sponsor's protocol ID
- H-17015584
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Progression of fovea-on Retinal Detachment
- ClinicalTrials.gov ID
- NCT03655652
- Acronym / sponsor ID
- H-17015584
- Conditions
- Retinal Detachment
- Keywords
- positioning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 31 Aug 2018 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a fovea-on retinal detachment referred to Rigshospitalet - Glostrup Department of Ophthalmology.
Key inclusion criteria (2 listed)
- fovea-on retinal detachment
- informed consent
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal detachment progression/regression
Time frame: 1-72 hours
Measured by OCT
1 secondary outcome
Positioning
Time frame: 1-72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Morten la Cour, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Detachment, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 4 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: status not confirmed, as of the sponsor's last update on 4 Sep 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Alberti, MD (+4551925195, malb0038@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal detachment progression/regression (time frame: 1-72 hours). 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 4 Sep 2018; AzTrials last refreshed its copy on 2 Nov 2026.