Clinical trial NCT02307981: Norwegian Occipital Ischemic Stroke Study
Official title: Management and Outcome of Visual Field Defects in Occipital Infarction (NOR-OCCIP)- A Multi-center Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Visual Field Defect
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Stavanger HF
name: St. Olavs Hospital
name: Statped Vest
name: Stavanger Municipality
First posted: 2014-12-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital based

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.

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.

Primary outcomes:
measure: Visual Field defect
timeFrame: 6 months
Secondary outcomes:
measure: Change in Visual function
timeFrame: 6 months
measure: Quality of life and self reported Visual function
timeFrame: 6 months
measure: NIHSS
timeFrame: One week
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
state: Rogaland
city: Trondheim
country: Norway
facility: St. Olav University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Kristin Modalsli Sand, MD
role: PRINCIPAL_INVESTIGATOR
References: