Clinical trial NCT01518686: Age-related Normative Values for the Octopus 900 Perimeter
Official title: Normal Values for the Full Visual Field, Corrected for Age- and Reaction Time, Using Semi-automated Kinetic Testing on the Octopus 900 Perimeter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Norm values
semi-automated kinetic perimetry
isopters
mathematical model
luminance
test-retest reliability
deviation
age dependance
different age groups
Healthy subjects
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Haag-Streit AG
First posted: 2012-01-26
Enrollment: 86
Sex: ALL
Minimum age (years): 11
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Measurement of the full Visual Field using semi-automated kinetic perimetry.
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Centre for Ophthalmology / Institute for Ophthalmic Research, University of Tübingen
state: Baden-Württemberg
Study officials:
affiliation: Centre for Ophthalmology / Institute for Ophthalmic Research, University of Tübingen, Germany
name: Ulrich Schiefer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: