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

NCT01372332 | Completed

• 1 other identifier: 086/2011BO2
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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 years

Study Arms (2)

Normal subjects

Age-related (+ 5 years of age) and gender-matched normal subjects.

Patients with homonymous hemianopia

Patients with homonymous visual field defects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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).

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen

Tübingen, Baden-Wurttemberg, D-72076, Germany

Location

Related Publications (4)

• 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.

  PMID: 24523869 BACKGROUND

• 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

  BACKGROUND

• Kasneci E, Sippel K, Heister M, Aehling K, Rosenstiel W, Schiefer U, Papageorgiou E. Homonymous Visual Field Loss and Its Impact on Visual Exploration: A Supermarket Study. Transl Vis Sci Technol. 2014 Nov 3;3(6):2. doi: 10.1167/tvst.3.6.2. eCollection 2014 Oct.

  PMID: 25374771 DERIVED

• Sippel K, Kasneci E, Aehling K, Heister M, Rosenstiel W, Schiefer U, Papageorgiou E. Binocular glaucomatous visual field loss and its impact on visual exploration--a supermarket study. PLoS One. 2014 Aug 27;9(8):e106089. doi: 10.1371/journal.pone.0106089. eCollection 2014.

  PMID: 25162522 DERIVED

MeSH Terms

Conditions

Hemianopsia

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulrich Schiefer, Prof. Dr.med.

  Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: June 10, 2011
• First Posted: June 13, 2011
• Study Start: June 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 28, 2014

Record last verified: 2014-05

Locations

DE (1)