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

NCT ID: NCT01372319

Last Updated: 2014-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-04-30

Brief Summary

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The purpose of this explorative study, targeting subjects with advanced binocular glaucomatous visual field loss, is: (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) OR attention-related parameters are better for the characterization of the visual capacities that are necessary for activities of daily living (ADL), as represented (iia) by a standardized visual search task and (iib) by an on-road car driving feasibility study.

Further this study is intended to introduce and analyse a novel diagnostic method for recording and evaluating exploratory eye movements (gaze-related perimetry) in a clinical setting. A similar procedure has recently been introduced by Murray et al. However, their set-up is based on a video monitor and, therefore, restricted to the central visual field (eccentricity \< 25°) and limited with regard to the dynamic range of the stimulus luminance. Since our new gaze-related perimetry is designed to be implemented in a conventional cupola perimeter, it should be widely available as a potent diagnostic tool, for screening purposes, or for clinical surveys by general ophthalmologists or clinical research groups.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Glaucoma Patients (OAG, Aulhorn stages II - IV)

Manifest glaucoma (OAG, Aulhorn stages II - IV) with advanced binocular visual loss, as obtained by semi-automated kinetic perimetry (SKP), no study medication

No interventions assigned to this group

Normal subjects

male+female \> 18 years

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

(ii) Ophthalmological: spherical ametropia max. ± 8 dpt, cylindrical ametropia max. ± 3 dpt, distant visual acuity \> 10/20, isocoria, pupil diameter \> 3 mm.

Exclusion Criteria

\- Normal subjects
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Ulrich Schiefer

Professor Dr. med Ulrich Schiefer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulrich Schiefer, Prof. Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen

Locations

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Centre for Ophthalmology University of Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 24523869 (View on PubMed)

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

Reference Type 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.

Reference Type DERIVED
PMID: 25374771 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25162522 (View on PubMed)

Other Identifiers

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085/2011B02

Identifier Type: -

Identifier Source: org_study_id

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