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

This study has been completed.

Sponsor:

Collaborator:

Haag-Streit AG, Schweiz

Information provided by (Responsible Party):

Ulrich Schiefer, University Hospital Tuebingen

ClinicalTrials.gov Identifier:

NCT01518686

First received: January 12, 2012

Last updated: January 25, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 12, 2012

Last Updated Date

January 25, 2012

Start Date ^ICMJE

June 2006

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01518686 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Age-related Normative Values for the Octopus 900 Perimeter

Official Title ^ICMJE

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

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).

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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)

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

11 Years to 79 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01518686

Other Study ID Numbers ^ICMJE

217/2006 local review board

Has Data Monitoring Committee

Responsible Party

Ulrich Schiefer, University Hospital Tuebingen

Study Sponsor ^ICMJE

University Hospital Tuebingen

Collaborators ^ICMJE

Haag-Streit AG, Schweiz

Investigators ^ICMJE

Principal Investigator:

Ulrich Schiefer, Prof. Dr. med.

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

Information Provided By

University Hospital Tuebingen

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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