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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01372332
Acronym
Hemi-Drive
Enrollment
60
Registered
2011-06-13
Start date
2011-06-30
Completion date
2013-04-30
Last updated
2014-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Homonymous Hemianopia

Keywords

homonymous hemianopia, quality of life (QoL), visual exploration, on-road car driving, driving simulator, useful field of view (UFOV), modified field of view (MAFOV)

Brief 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.

Interventions

None listed

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
University Hospital Tuebingen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Identification of the perimetric / psychophysical method, that is most closely correlated with an individually assessed quality of life (QoL) score2 yearsQuality 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

MeasureTime frameDescription
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)2 years1. 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026