NCT03187613

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

June 21, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 28, 2021

Status Verified

October 1, 2020

Enrollment Period

3.5 years

First QC Date

June 13, 2017

Last Update Submit

September 27, 2021

Conditions

Retinal Detachment

Keywords

Retinal shiftAniseikoniaMetamorphopsiaAutofluorescence

Outcome Measures

Primary Outcomes (1)

  • Retinal shift

    Measured on fundus autofluorescence

    2 years

Secondary Outcomes (4)

  • Visual acuity

    6 and 24 months

  • Metamorphopsia

    6 and 24 months

  • Aniseikonia

    6 and 24 months

  • Stereopsis

    6 and 24 months

Eligibility Criteria

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

Individuals treated at Stavanger University Hospital

You may qualify if:

  • Acute rhegmatogenous retinal detachment, fovea detached, able to signe

You may not qualify if:

  • Secondary retinal detachment like tractional, serous or with ora serrata dialysis, fovea on

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital, Department of Ophthalmology

Stavanger, 4016, Norway

Location

Related Publications (3)

  • Thomseth VM, Lindtjorn B, Ushakova A, Forsaa VA. LONG-TERM CHANGES IN VISUAL FUNCTION AND EN FACE OPTICAL COHERENCE TOMOGRAPHY FINDINGS IN FOVEA-OFF RETINAL DETACHMENT: A 2-Year Prospective Study. Retina. 2023 Feb 1;43(2):330-337. doi: 10.1097/IAE.0000000000003670.

    PMID: 36695802DERIVED

  • Thomseth VM, Ushakova A, Krohn J, Utheim TP, Austeng D, Fossen K, Varhaug P, Malmin A, Skeiseid L, Tharaldsen A, Lindtjorn B, Johannesen H, Juul J, Forsaa VA. STRUCTURAL PATHOLOGY AFTER RETINAL DETACHMENT: Multicolor Confocal Scanning Laser Ophthalmoscopy Versus Color Fundus Photography. Retina. 2021 Sep 1;41(9):1958-1965. doi: 10.1097/IAE.0000000000003113.

    PMID: 33464027DERIVED

  • Thomseth VM, Engelsvold DH, Ushakova A, Forsaa VA. EN FACE IMAGING OF OUTER RETINAL PATHOLOGY AFTER RETINAL DETACHMENT. Retina. 2021 Feb 1;41(2):324-330. doi: 10.1097/IAE.0000000000002814.

    PMID: 32282661DERIVED

MeSH Terms

Conditions

Retinal DetachmentAniseikoniaVision Disorders

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesRefractive ErrorsSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vegard Forsaa, MD

    Helse Stavanger HF

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 15, 2017

Study Start

June 21, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

September 28, 2021

Record last verified: 2020-10

Locations

NO(1)