NCT02307981

Brief Summary

Patients who suffer an ischemic stroke in the occipital lobe often experience Visual Field defects. Visual Field defects are negatively correlated to falling, institutionalisation, rehabilitation outcome and quality of life. Patients are often not properly examined and seldom receive rehabilitation. NOR-OCCIP aims to evaluate the Natural history of Visual Field defects after occipital infarction and to determine whether rehabilitation is effective.

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
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

August 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

2.1 years

First QC Date

November 28, 2014

Last Update Submit

August 17, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Field defect

    Change in Visual Field defect as measured by autoperimetry

    6 months

Secondary Outcomes (3)

  • Change in Visual function

    6 months

  • Quality of life and self reported Visual function

    6 months

  • NIHSS

    One week

Study Arms (2)

Visual field defect with vision teacher

Patients With occipital ischemic stroke and Visual Field defect that live in a geographical region where training With vision teacher is an available service (vision Teachers are a Limited Resource in Norway)

Other: Training with vision teacher (visual rehabilitation)

Visual field defect without vision teacher

Patients With occipital ischemic stroke and a Visual Field defect, who live in a geographical area where training With vision teacher is not an available service.

Interventions

Individually adapted training With vision teacher

Visual field defect with vision teacher

Eligibility Criteria

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

Hospital based

You may qualify if:

  • Written consent obtained,
  • age \>18,
  • acute occipital infarction on brain imaging and ability to cooperate for examination with autoperimetry

You may not qualify if:

  • Pathological processes that severely affect eyesight.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stavanger University Hospital

Stavanger, Rogaland, Norway

Location

St. Olav University Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kristin Modalsli Sand, MD

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kristin Modalsli Sand MD

Study Record Dates

First Submitted

November 28, 2014

First Posted

December 4, 2014

Study Start

August 1, 2013

Primary Completion

September 1, 2015

Study Completion

June 1, 2016

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations