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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01518686
First Posted: January 26, 2012
Last Update Posted: December 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Haag-Streit AG
Information provided by (Responsible Party):
Ulrich Schiefer, University Hospital Tuebingen
  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: None (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 Ulrich Schiefer, University Hospital Tuebingen:

Primary Outcome Measures:
  • Measurement of the full Visual Field using semi-automated kinetic perimetry. [ Time Frame: one day ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 79 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 12, 2012
First Posted: January 26, 2012
Last Update Posted: December 11, 2013
Last Verified: December 2013

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