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

Homonymous Hemianopia Clinical Trial

— Hemi-Drive  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372332
• Other study ID #: 086/2011BO2
• Status: Completed
• Phase: N/A
• First received: June 10, 2011
• Last updated: May 27, 2014
• Start date: June 2011
• Est. completion date: April 2013

Study information

• Verified date: May 2014
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemianopsia
• Homonymous Hemianopia

Locations

Country	Name	City	State
Germany	Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen	Tübingen	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Kasneci E, Sippel K, Aehling K, Heister M, Rosenstiel W, Schiefer U, Papageorgiou E. Driving with binocular visual field loss? A study on a supervised on-road parcours with simultaneous eye and head tracking. PLoS One. 2014 Feb 11;9(2):e87470. doi: 10.1371/journal.pone.0087470. eCollection 2014. — View Citation

Kübler T, Kasneci E, Rosenstiel W, Schiefer U, Nagel K, Papageorgiou E. Stress-indicators and exploratory gaze for the analysis of hazard perception in patients with visual field loss. Science Direct, Transportation Research Part F 24: 231-43, 2014

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of the perimetric / psychophysical method, that is most closely correlated with an individually assessed quality of life (QoL) score	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)	2 years	No
Secondary	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)	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); 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	2 years	No