Age-related Normative Values for the Octopus 900 Perimeter (Norm-Oct900)

Normal Values for the Full Visual Field, Corrected for Age- and Reaction Time, Using Semi-automated Kinetic Testing on the Octopus 900 Perimeter

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland)

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Centre for Ophthalmology / Institute for Ophthalmic Research, University of Tübingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 79 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

No Intervention: one arm; observational study, no cohort, single group of different ages

Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the full Visual Field using semi-automated kinetic perimetry.	additional a subgroup of 14 participants were tested at 3 separate sessions within 4 weeks.	one day

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Haag-Streit AG
• Investigators: Principal Investigator: Ulrich Schiefer, Prof. Dr. med., Centre for Ophthalmology / Institute for Ophthalmic Research, University of Tübingen, Germany

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: January 12, 2012
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 26, 2012

Study Record Updates

• Last Update Posted (Estimate): December 11, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Healthy subjects; test-retest reliability; semi-automated kinetic perimetry; Norm values; isopters; mathematical model; luminance; deviation; age dependance; different age groups
• Other Study ID Numbers: 217/2006 local review board