Assessment of Homonymous Visual Loss and Its Impact on Visual Exploration, Activities of Daily Living (ADL) and Quality of Life (QoL) (Hemi-Drive)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ulrich Schiefer, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01372332
First received: June 10, 2011
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

The purpose of this explorative study, targeting subjects with homonymous visual field loss, is threefold:

(i) to identify the perimetric / psychophysical method, that is most closely correlated with an individually assessed quality of life (QoL) score, using a validated questionnaire (NEI-VFQ 25) (ii) to determine, whether gaze-related (exploratory eye movements) or visual field-related (eyes steadily fixating) parameters are better for the characterization of the visual capacities that are necessary for activities of daily living (ADL), as represented by (iia) a standardized visual search task ("supermarket special offer search task") (iib) by an on-road car driving pilot study.


Condition
Homonymous Hemianopia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Homonymous Visual Loss and Its Impact on Visual Exploration, Activities of Daily Living (ADL) and Quality of Life (QoL)

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Identification of the perimetric / psychophysical method, that is most closely correlated with an individually assessed quality of life (QoL) score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Quality of life (QoL) is better correlated with the modified ESTERMAN score of the binocular semi-automated kinetic perimetry of the 90° visual field than with the number of affected test locations (local sensitivity < 10 dB) according to the binocular integrated visual field (IVF)


Secondary Outcome Measures:
  • Exploration whether gaze-related or visual field-related parameters are better for the characterization of the visual capacities that are necessary for activities of daily living (ADL) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    1. Activities of daily living ("supermarket special offer search task"), are better correlated with the modified ESTERMAN score, based on the intact binocular gaze field than with the modified ESTERMAN score, based on the binocular semi-automated kinetic perimetry of the 90° visual field (90° SKP)
    2. Activities of daily living (driving performance) are better correlated with (the ESTERMAN score, based on) the intact binocular gaze field than with the UFOV risk score


Enrollment: 60
Study Start Date: June 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal subjects
Age-related (+ 5 years of age) and gender-matched normal subjects.
Patients with homonymous hemianopia
Patients with homonymous visual field defects

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

30 patients with homonymous visual field defects and 30 age-related (+ 5 years of age) and gender-matched normal subjects. All subjects are free to stop participation of the tests at any time without any consequences on the future treatment of the patient. The circumstances of any discontinuation will be documented.

Criteria

Inclusion Criteria:

- Patients with homonymous visual field defects Primary inclusion criterion: (Stable) homonymous visual field defects, as obtained by binocular semi-automated kinetic perimetry (SKP), using the III4e stimulus, within on onset of at least six months ago, due to a vascular or a traumatic lesion.

Further inclusion criteria: (i) general: physical, intellectual and linguistic abilities, necessary to understand the test requirements: no mobility limitations / hemiparesis, Minimental Status Examination Test score above 24, adequate knowledge of the German language, willingness to comply with the protocol, > 18 years, informed consent.

(ii) Ophthalmological: spherical ametropia max. ± 8 dpt, cylindrical ametropia max. ± 3 dpt, best corrected distant visual acuity > 6/12 (= 0.5), isocoria, pupil diameter > 3 mm, intraocular pressure ≤ 21 mmHg, normal anterior segments, no clinically relevant media opacities, normal appearance of the optic disc (cup to disc ratio = CDR ≤ 0.5, intraocular difference of CDR < 0.3).

- Normal subjects (i) General inclusion criteria: Physical, intellectual and linguistic abilities needed to understand the test requirements: no mobility limimtaions / hemiparesis, Minimental Status Examination Test score above 24, adequate knowledge of the German language, willingness to comply with the protocol, > 18 years, informed consent.

(ii) Ophthalmological inclusion criteria: maximum allowed spherical ametropia at distance is ± 6.00 diopters and the maximum cylindrical ametropia is ± 2 diopters. The best corrected distance visual acuities are equal to, or better than 20/20 and 1.0, respectively, for those aged up to 60 years; better than 20/25 and 0.8 for those aged between 60 and 70 years; and better than, or equal to, 20/33 and 0.6 for those aged more than 70 years. All participants manifest equal pupil size, pupil diameter > 3 mm, no relative afferent pupillary defect, intraocular pressure ≤ 21 mmHg, normal anterior segments, no clinically relevant media opacities, normal appearance of the optic disc (cup to disc ratio = CDR ≤ 0.5, intraocular difference of CDR < 0.3) and normal central and peripheral fundus findings on direct and indirect undilated ophthalmoscopic examination.

Exclusion Criteria:

- Patients with homonymous visual field defects: (i) General exclusion criteria: Pregnancy, nursing, asthma, HIV+ or AIDS, history of epilepsy or significant psychiatric disease, history of drug and alcohol abuse, Minimental Status Examination Test score below 24, medications known to affect visual field sensitivity.

(ii) Ophthalmological exclusion criteria: diabetic retinopathy, infections (e.g. keratitis, conjunctivitis, uveitis), severe dry eyes, miotic drug, amblyopia, squint, nystagmus, albinism, any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields, disc imaging or accurate IOP readings, keratoconus, intraocular surgery (except for uncomplicated cataract surgery) performed < 3 month prior to screening, protanopia, deuteranopia, history or presence of macular disease and / or macular edema, ocular trauma.

- Normal subjects: (i) General exclusion criteria: pregnancy, nursing, mental or neurological diseases, Minimental Status Examination Test score below 24, history of coronary heart disease, stroke, diabetes mellitus, migraine, vasospasm/ Raynaud`s disease, drugs indicating severe systemic diseases (e.g. anti-diabetic or anti-hypertensive medication for subjects under 70 years of age), drugs or medications influencing reaction time, history of drug and alcohol abuse, suspected lack of compliance. Subjects over 70 years of age will not be excluded for use of anti-hypertensive medication.

(ii) Ophthalmological exclusion criteria: Amblyopia, strabismus, ocular motility disorders, retinal pathology, glaucoma, suspicion of glaucoma, ocular hypertension or any other sign of other optic neuropathy, macular degeneration, protanopia, deuteranopia, eye surgery (except for uncomplicated cataract surgery), any type of refractive surgery, history or signs of neuro-ophthalmological diseases, acute infections, diabetic retinopathy, use of miotic drugs.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01372332

Locations
Germany
Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen
Tübingen, Baden-Württemberg, Germany, D-72076
Sponsors and Collaborators
University Hospital Tuebingen
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Ulrich Schiefer, Prof. Dr.med. Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen
  More Information

Publications:
Responsible Party: Ulrich Schiefer, Prof. Dr. med., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01372332     History of Changes
Other Study ID Numbers: 086/2011BO2
Study First Received: June 10, 2011
Last Updated: May 27, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:
homonymous hemianopia
quality of life (QoL)
visual exploration
on-road car driving
driving simulator
useful field of view (UFOV)
modified field of view (MAFOV)

Additional relevant MeSH terms:
Hemianopsia
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Blindness
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014