Norwegian Occipital Ischemic Stroke Study

NCT ID: NCT02307981

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-06-30

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.

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.

Conditions

Ischemic Stroke; Visual Field Defect

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Training with vision teacher (visual rehabilitation)

Intervention Type: OTHER

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.

No interventions assigned to this group

Interventions

Training with vision teacher (visual rehabilitation)

Individually adapted training With vision teacher

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Statped Vest

UNKNOWN

Sponsor Role: collaborator

Stavanger Municipality

UNKNOWN

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kristin Modalsli Sand

Kristin Modalsli Sand MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Modalsli Sand, MD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Stavanger University Hospital

Stavanger, Rogaland, Norway

St. Olav University Hospital

Trondheim, , Norway

Countries

Norway

Other Identifiers

2012/2307

Identifier Type: -

Identifier Source: org_study_id