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

NCT01372319 | Completed

• 1 other identifier: 085/2011B02
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma

Keywords

glaucoma; binocular visual field loss; semi-automated kinetic perimetry (SKP); quality of life (QoL); visual exploration; on-road car driving; driving simulator

Outcome Measures

Primary Outcomes (2)

• Identification of the perimetric / psychophysical method, that is most closely correlated with an individually assessed quality of life (QoL) score.

  Quality of life (QoL), assessed with the NEI-VFQ 25 questionnaire, is better correlated with the modified ESTERMAN score, based on the binocular semi-automated kinetic perimetry of the 90° visual field (90° SKP) than with the number of affected test locations (local sensitivity \< 10 dB) according to the binocular integrated visual field (IVF).

  2 years

• Determination of the most appropriate parameters (gaze-related ; visual field-related; attention-related) for the characterization of the visual capacities for activities of daily living

  Performance regarding activities of daily living (ADL), as represented by the "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) OR the with the number of affected test locations (local sensitivity \< 10 dB) of the binocular integrated visual field (IVF) OR the UFOV risk score.

  2 years

Secondary Outcomes (3)

• Comparison of the comprehensive psychophysical examinations

  2 years

• Comparison and evaluation of two different assessments of visual exploration under real-life scenarios ("supermarket special offer search task", "on-road car driving" by means of a dual brake vehicle (optional: driving simulator)

  2 years

• Descriptive assessment of structure-function relationships by comparing the results of the different perimetric tests with the morphometric results of HRT III

  2 years

Study Arms (2)

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

Normal subjects

male+female \> 18 years

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

First year: 10 glaucoma patients, with advanced binocular visual loss and 10 age-related (+ 5 years of age) and gender-matched normal subjects. Second year: Extension to a total number 30 glaucoma patients, with advanced binocular visual loss and 30 age-related (+ 5 years of age) and gender-matched normal subjects (according to the sample size estimation), if additional budget available.

You may qualify if:

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

You may not qualify if:

• \- Normal subjects

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Pfizer: collaborator

Study Sites (1)

Centre for Ophthalmology 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

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

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: Professor Dr. med Ulrich Schiefer

Study Record Dates

• First Submitted: June 10, 2011
• First Posted: June 13, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: May 28, 2014

Record last verified: 2014-05

Locations

DE (1)