Age-related Normative Values for the Octopus 900 Perimeter

NCT ID: NCT01518686

Last Updated: 2013-12-11

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

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to determine normal values of the visual field (VF), corrected for age- and reaction time (RT) using the Octopus 900 perimeter and semi-automated kinetic perimetry (SKP).

Detailed Description

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Conditions

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Healthy

Keywords

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Norm values semi-automated kinetic perimetry isopters mathematical model luminance test-retest reliability deviation age dependance different age groups Healthy subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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one arm

observational study, no cohort, single group of different ages

Group Type NO_INTERVENTION

Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland)

Intervention Type DEVICE

We used the following six combinations of Goldmann8,1 stimulus size, stimulus luminance and angular velocity: V4e (64mm², 103', 320cd/m²) at 5°/s, III4e (4mm², 25.7', 320cd/m²) at 5°/s, I4e (0.25mm², 6.45', 320cd/m²) at 2°/s (for the assessment of the blind spot), I3e (0.25mm², 6.45', 100cd/m²) at 5°/s, I2e (0.25mm², 6.45', 32cd/m²) at 3°/s, I1e (0.25mm², 6.45', 10cd/m²) at 3°/s, I1a (0.25mm², 6.45', 4cd/m²) at 2°/s .

The peripheral five isopters, consisting of 24 vectors (every 15° meridian), were presented in random order, while the innermost isopter (I1a) consisted of 12 vectors (every 30° meridian)

Interventions

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Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland)

We used the following six combinations of Goldmann8,1 stimulus size, stimulus luminance and angular velocity: V4e (64mm², 103', 320cd/m²) at 5°/s, III4e (4mm², 25.7', 320cd/m²) at 5°/s, I4e (0.25mm², 6.45', 320cd/m²) at 2°/s (for the assessment of the blind spot), I3e (0.25mm², 6.45', 100cd/m²) at 5°/s, I2e (0.25mm², 6.45', 32cd/m²) at 3°/s, I1e (0.25mm², 6.45', 10cd/m²) at 3°/s, I1a (0.25mm², 6.45', 4cd/m²) at 2°/s .

The peripheral five isopters, consisting of 24 vectors (every 15° meridian), were presented in random order, while the innermost isopter (I1a) consisted of 12 vectors (every 30° meridian)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* maximum spherical ametropia ± 6 Diopters (D)
* maximum cylindrical ametropia ± 2 D
* distant visual acuity ≥ 1.0 logMAR \[20/20\] for subjects up to 60 years, ≥ 0.8 logMAR \[20/25\] for subjects from 61-70 years, ≥ 0.63 logMAR \[20/30\] for subjects older than 70 years
* isocoria, pupil diameter \> 3mm
* intraocular pressure (air pulse tonometer) ≤ 21mmHg
* normal anterior segments
* ocular fundus: normal appearance of the cup to disc ratio (CDR) ≤ 0.5, interocular difference of CDR \< 0.3
* normal macular region, vessels, and peripheral retinal examination (with undilated pupils).

Exclusion Criteria

* amblyopia
* strabismus
* ocular motility disorder
* diseases of the retina
* glaucoma, glaucoma suspect
* macular degeneration
* IOP \> 21 mmHg
* abnormal color vision test (ISPP - Ishihara and Standard Pseudoisochromatic Plates = SPP)
* history or findings of other neuro-ophthalmological disease
* relevant opacities of the central refractive media (cornea, lens, vitreous body)
* use of miotic drugs
* intraocular surgery (except uncomplicated cataract surgery, more than three months previous to testing)
* kerato-refractive surgery (LASIK)
* drugs influencing reaction time
* drugs indicating severe general diseases (anti-diabetic pharmaceuticals and anti-hypertensive medication were allowed for subjects older than 70 years)
* mental diseases (for example psychosis)
* pregnancy, nursing
* acute infections
* heavy smoking (\>10 cigarettes /day)
* alcohol abuse
* diabetic retinopathy
* coronary heart disease
* stroke
* migraine
* Raynaud's syndrome
* suspected lack of compliance
Minimum Eligible Age

11 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Haag-Streit AG

INDUSTRY

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Ulrich Schiefer

Prof. 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, Germany

Locations

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Centre for Ophthalmology / Institute for Ophthalmic Research, University of Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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217/2006 local review board

Identifier Type: -

Identifier Source: org_study_id