NCT03655652

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

August 30, 2018

Last Update Submit

August 31, 2018

Conditions

Retinal Detachment

Keywords

positioning

Outcome Measures

Primary Outcomes (1)

  • Retinal detachment progression/regression

    Measured by OCT

    1-72 hours

Secondary Outcomes (1)

  • Positioning

    1-72 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • fovea-on retinal detachment
  • informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Rigshospitalet - Glostrup

Glostrup Municipality, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Central Study Contacts

Mark Alberti, MD

CONTACT

+4551925195malb0038@regionh.dk

Morten la Cour, MD

CONTACT

molco@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2018

First Posted

August 31, 2018

Study Start

February 1, 2018

Primary Completion

February 1, 2019

Study Completion

October 1, 2019

Last Updated

September 4, 2018

Record last verified: 2018-08

Locations

DK(1)