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

This study has been completed.
Sponsor:
Collaborator:
Haag-Streit AG
Information provided by (Responsible Party):
Ulrich Schiefer, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01518686
First received: January 12, 2012
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention
Healthy
Device: Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Measurement of the full Visual Field using semi-automated kinetic perimetry. [ Time Frame: one day ] [ Designated as safety issue: No ]
    additional a subgroup of 14 participants were tested at 3 separate sessions within 4 weeks.


Enrollment: 86
Study Start Date: June 2006
Study Completion Date: September 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


  Eligibility

Ages Eligible for Study:   11 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518686

Locations
Germany
Centre for Ophthalmology / Institute for Ophthalmic Research, University of Tübingen
Tübingen, Baden-Württemberg, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Haag-Streit AG
Investigators
Principal Investigator: Ulrich Schiefer, Prof. Dr. med. Centre for Ophthalmology / Institute for Ophthalmic Research, University of Tübingen, Germany
  More Information

No publications provided

Responsible Party: Ulrich Schiefer, Prof. Dr. med Ulrich Schiefer, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01518686     History of Changes
Other Study ID Numbers: 217/2006 local review board
Study First Received: January 12, 2012
Last Updated: December 10, 2013
Health Authority: Germany: Local review board of the University of Tübingen

Keywords provided by University Hospital Tuebingen:
Norm values
semi-automated kinetic perimetry
isopters
mathematical model
luminance
test-retest reliability
deviation
age dependance
different age groups
Healthy subjects

ClinicalTrials.gov processed this record on April 14, 2014