Norwegian Occipital Ischemic Stroke Study (NOR-OCCIP)

Management and Outcome of Visual Field Defects in Occipital Infarction (NOR-OCCIP)- A Multi-center Prospective Study

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Stroke; Visual Field Defect
• Intervention / Treatment: Other: Training with vision teacher (visual rehabilitation)

Detailed Description

BACKGROUND: Visual Field defects after cerebral infarction is an increasingly acknowledged problem, which has consequences for patient outcome. The aim of the Norwegian Occipital Ischemic Stroke Study (NOR-OCCIP) is to: 1.) Improve clinical diagnostics and management of visual field defects in occipital stroke. 2.) Identify and estimate the need for visual rehabilitation among patients with VFD by studying the natural course and the rate of spontaneous recovery. 3.) Study the effect of visual rehabilitation both on visual function as well as on quality of life. METHODS: Patients with acute ischemic occipital stroke on MRI are recruited from Bergen, Stavanger and Trondheim. Patients are included for a period of 1.5 years, starting August 15th 2013. Patients are eligible for inclusion if >18 years, written consent is obtained and the patient is able to co-operate to examination with autoperimetry. Within one week patients are examined by ophthalmologist after a standardized protocol including autoperimetry. During week four patients are examined by vision teacher after a standardized protocol and a structured interview on vision specific function and quality of life (VFQ-25) is conducted by a study nurse via telephone. If visual rehabilitation is provided by the municipality in which the patient lives, the patient will be referred to such. Eye examination including autoperimetry, vision teacher assessment and VFQ-25 is repeated after 6 months. All patients will be registered in the national stroke registry, and the following variables will be analysed: Demographic variables, lifestyle factors, clinical status at admission (scores on NIHSS), clinical status at discharge and 3 months post-stroke (scores on modified Rankin Scale). So far 62 patients have been included. Limited research exists on visual impairment after cerebral infarction. It is important to establish the natural course of visual impairment after ischemic stroke, and to evaluate the effect of visual rehabilitation.

• Study Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St. Olav University Hospital
  • Rogaland
    • Stavanger, Rogaland, Norway
      • Stavanger University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospital based

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pathological processes that severely affect eyesight.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Individually adapted training With vision teacher
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Field defect	Change in Visual Field defect as measured by autoperimetry	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual function	Change in Visual function as measured by standardized mapping by vision teacher according to pre-specified protocol	6 months
Quality of life and self reported Visual function	Vision specific QoL and function as measured by VFQ-25	6 months
NIHSS		One week

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Helse Stavanger HF; St. Olavs Hospital; Stavanger Municipality; Statped Vest
• Investigators: Principal Investigator: Kristin Modalsli Sand, MD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: November 28, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Estimate): August 19, 2015
• Last Update Submitted That Met QC Criteria: August 17, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: 2012/2307