Assessment of Advanced Glaucomatous Visual Field 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

NCT01372319

Acronym

GlaucomaEXPLOR

Enrollment

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

Glaucoma

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Glaucoma subjects Primary inclusion criteria: Open angle glaucoma (OAG), according to the classification of the European Glaucoma Society (EGS)11 with advanced binocular visual loss (i.e stages II - IV according to the classification after Aulhorn et al.4, as obtained by semi-automated kinetic perimetry (SKP) or automated static threshold-related, slightly supraliminal perimetry (sAS) 3,10 22 \[Grid 30°-NO (192 test points), stimulus Goldmann size III = 26´, OCTOPUS 101/900 perimeter (Haag-Streit Inc., Köniz, Switzerland)\]. * Further inclusion criteria: (i) General: physical, intellectual and linguistic abilities, necessary to understand the test requirements: no mobility limitations, 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, distant visual acuity \> 10/20, isocoria, pupil diameter \> 3 mm. \- Normal subjects (i) General inclusion criteria: Physical, intellectual and linguistic abilities needed to understand the test requirements: no mobility limitations, 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 dpt. The best corrected distance visual acuities are ≥ 20/20 (1.0) for those aged up to 60 years; \> 20/25 (0.8) for those aged between 60 and 70 years; ≥ 20/33 (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

* Glaucoma subjects (i) General

Design outcomes

Primary

Measure	Time frame	Description
Identification of the perimetric / psychophysical method, that is most closely correlated with an individually assessed quality of life (QoL) score.	2 years	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).
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	2 years	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.

Secondary

Measure	Time frame	Description
Comparison of the comprehensive psychophysical examinations	2 years	The scotoma extent, assessed with MAFOV, is equal to the scotoma extent assessed with the fast thresholding conventional static automated perimetry (SAP) (GATE strategy, Grid 30-S). Additionally, test/re-test reliability will be assessed with regard to (i) MAFOV and (ii) SAP (as described above), assuming that test/retest reliability is identical between MAFOV and SAP.
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	Performance regarding acitivities of daily living (ADL), as assessed by the supermarket special offer search task and the on-road car driving pilot study, are better correlated with (the ESTERMAN score, based on) the intact binocular gaze field than with (the 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.
Descriptive assessment of structure-function relationships by comparing the results of the different perimetric tests with the morphometric results of HRT III	2 years	—

Countries

Germany

Outcome results