Correlation of Metamorphopsia and Aniseikonia to Retinal Shift Following Retinal Detachment Surgery

September 27, 2021 updated by: Helse Stavanger HF
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

38

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

  • Norway
      • Stavanger, Norway, 4016
        • Stavanger University Hospital, Department of Ophthalmology

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals treated at Stavanger University Hospital

Description

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 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 shift
Time Frame: 2 years
Measured on fundus autofluorescence
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 6 and 24 months
Best Corrected Visual Acuity
6 and 24 months
Metamorphopsia
Time Frame: 6 and 24 months
M-Chart
6 and 24 months
Aniseikonia
Time Frame: 6 and 24 months
New Aniseikonia Test
6 and 24 months
Stereopsis
Time Frame: 6 and 24 months
Titmus Test
6 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Investigators

  • Study Director: Vegard Forsaa, MD, Helse Stavanger HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 21, 2017

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

June 13, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 15, 2017

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/730 REK

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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