Norwegian Occipital Ischemic Stroke Study

Ischemic Stroke Clinical Trial

— NOR-OCCIP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02307981
• Other study ID #: 2012/2307
• Status: Active, not recruiting
• Phase: N/A
• First received: November 28, 2014
• Last updated: August 17, 2015
• Start date: August 2013
• Est. completion date: June 2016

Study information

• Verified date: August 2015
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Regional Ethics Commitee Norway: REK Sør-Øst
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: June 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Visual Field Defect

Intervention

Other:
• Training with vision teacher (visual rehabilitation)
Individually adapted training With vision teacher

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger	Rogaland
Norway	St. Olav University Hospital	Trondheim

Sponsors (5)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Stavanger HF, St. Olavs Hospital, Statped Vest, Stavanger Municipality

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Field defect	Change in Visual Field defect as measured by autoperimetry	6 months	No
Secondary	Change in Visual function	Change in Visual function as measured by standardized mapping by vision teacher according to pre-specified protocol	6 months	No
Secondary	Quality of life and self reported Visual function	Vision specific QoL and function as measured by VFQ-25	6 months	No
Secondary	NIHSS		One week	No