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

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ClinicalTrials.gov Identifier: NCT03187613
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF

Brief 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.

Condition or disease
Retinal Detachment

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of Metamorphopsia and Aniseikonia to Retinal Shift Following Retinal Detachment Surgery
Actual Study Start Date : June 21, 2017
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Retinal shift [ Time Frame: 2 years ]
    Measured on fundus autofluorescence


Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: 6 and 24 months ]
    Best Corrected Visual Acuity

  2. Metamorphopsia [ Time Frame: 6 and 24 months ]
    M-Chart

  3. Aniseikonia [ Time Frame: 6 and 24 months ]
    New Aniseikonia Test

  4. Stereopsis [ Time Frame: 6 and 24 months ]
    Titmus Test



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals treated at Stavanger University Hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187613


Contacts
Contact: Vegard Forsaa, MD +47 48152212 forsaa@gmail.com

Locations
Norway
Stavanger University Hospital, Department of Ophthalmology Recruiting
Stavanger, Norway, 4016
Contact: Vegard Forsaa, MD    +47 48152212    vegard.forsaa@sus.no   
Principal Investigator: Vegard Forsaa, MD         
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Study Director: Vegard Forsaa, MD Helse Stavanger HF

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT03187613     History of Changes
Other Study ID Numbers: 2017/730 REK
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helse Stavanger HF:
Retinal shift
Aniseikonia
Metamorphopsia
Autofluorescence

Additional relevant MeSH terms:
Vision Disorders
Dissociative Disorders
Retinal Detachment
Aniseikonia
Mental Disorders
Retinal Diseases
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Refractive Errors