NCT05809973

Brief Summary

Longitudinal, prospective, single-center observational study of visual impairment after stroke. Population: Patients admitted with acute ischemic stroke at the Regional Stroke Unit at Oslo University Hospital who are assessed to not have more serious neurological deficits than to be eligible for a prospective observational study of visual impairment. National Institute of Health Stroke Scale (NIHSS) will be used for screening of the patients eligible for the study with cut off of NIHSS 20. Based on the number of patients admitted to our center to include 120 patients in the StrokeVIS study. The study aims are:

  1. 1.To determine the prevalence of visual impairment in stroke patients in the acute phase and after 3 months.
  2. 2.To compare visual impairment in those treated with EVT and those not.
  3. 3.To determine the sensitivity and specificity of the Vision Screening Assessment (VISA) tool for detection of visual impairment in stroke patients.
  4. 4.To assess possible association between brain MRI lesions and visual impairment in stroke patients in the acute phase.
  5. 5.Acute ischemic stroke and NIHSS \< 20
  6. 6.Age ≥18 years.
  7. 7.Written informed consent of the patient or oral informed consent witnessed by a doctor.
  8. 8.NIHSS \< 20
  9. 9.No willingness and ability of the patient to participate in all baseline and follow-up examinations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

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

Study Start

First participant enrolled

November 15, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

March 30, 2023

Last Update Submit

September 26, 2025

Conditions

Stroke, Acute

Keywords

visual impairmentthrombectomyacute ischemic strokeVISA

Outcome Measures

Primary Outcomes (1)

  • Best-corrected visual acuity for distance and near, reading ability

    90 days

Secondary Outcomes (5)

  • Automated perimetry with the monocular Esterman program, alternatively confrontational visual field examination for patients who are unable to perform perimetry

    90 days

  • Ocular motility

    90 days

  • Visual attention and perception

    90 days

  • Direct ophthalmoscopy

    90 days

  • National Institute of Health Stroke Scale

    90 days

Interventions

VISA toolDIAGNOSTIC_TEST

Validation of VISA

Eligibility Criteria

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

Patients admitted with acute ischemic stroke at the Regional Stroke Unit at Oslo University Hospital who are assessed to not have more serious neurological deficits than to be eligible for a prospective observational study of visual impairment. National Institute of Health Stroke Scale (NIHSS) will be used for screening of the patients eligible for the study with cut off of NIHSS 20.

You may qualify if:

  • Acute ischemic stroke and NIHSS \< 20
  • Age ≥18 years.
  • Written informed consent of the patient or oral informed consent witnessed by a doctor.

You may not qualify if:

  • NIHSS \< 20
  • No willingness and ability of the patient to participate in all baseline and follow-up examinations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

StrokeVision DisordersIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 12, 2023

Study Start

November 15, 2021

Primary Completion

May 21, 2024

Study Completion

December 31, 2024

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)