Preoperative Progression of Retinal Detachment | NCT03655652

Studies
Preoperative Progression of Retinal Detachment

NCT03655652

Sponsor

Glostrup University Hospital, Copenhagen

Status

Unknown status

Last Update Posted

Sep 4, 2018Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Retinal Detachment

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Feb 1, 2019Estimated

Completion Date

Oct 1, 2019Estimated

First Submitted Date

Aug 30, 2018

First Submission Date that Met QC Criteria

Aug 30, 2018

First Posted Date

Aug 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2018

Last Update Posted Date

Sep 4, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mark Alberti, Principal Investigator, Glostrup University Hospital, CopenhagenPrincipal Investigator

Lead Sponsor

Glostrup University Hospital, CopenhagenOTHER

Collaborators

Name	Class
Aarhus University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retinal detachment progression/regression	Measured by OCT	1-72 hours

Secondary Outcomes

Measure	Description	Time Frame
Positioning	Measured by device	1-72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a fovea-on retinal detachment referred to Rigshospitalet - Glostrup Department of Ophthalmology.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mark Alberti, MD	Contact	+4551925195		malb0038@regionh.dk
Morten la Cour, MD	Contact			molco@regionh.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, Rigshospitalet - Glostrup	Recruiting	Glostrup Municipality		2600	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012163	Retinal Detachment

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided