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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03187613
Other study ID # 2017/730 REK
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 21, 2017
Est. completion date December 31, 2020

Study information

Verified date October 2020
Source Helse Stavanger HF
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Individuals operated for rhegmatogenous retinal detachment will be prospectively evaluated for postoperative retinal shift. Fundus autofluorescence will be used to evaluate retinal shift that will be correlated to visual acuity, metamorphopsia, aniseikonia, and stereopsis.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Acute rhegmatogenous retinal detachment, fovea detached, able to signe Exclusion Criteria: - Secondary retinal detachment like tractional, serous or with ora serrata dialysis, fovea on

Study Design


Locations

Country Name City State
Norway Stavanger University Hospital, Department of Ophthalmology Stavanger

Sponsors (1)

Lead Sponsor Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retinal shift Measured on fundus autofluorescence 2 years
Secondary Visual acuity Best Corrected Visual Acuity 6 and 24 months
Secondary Metamorphopsia M-Chart 6 and 24 months
Secondary Aniseikonia New Aniseikonia Test 6 and 24 months
Secondary Stereopsis Titmus Test 6 and 24 months
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