NCT01518686

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

1.8 years

First QC Date

January 12, 2012

Last Update Submit

December 10, 2013

Conditions

Healthy

Keywords

Norm valuessemi-automated kinetic perimetryisoptersmathematical modelluminancetest-retest reliabilitydeviationage dependancedifferent age groupsHealthy subjects

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

one arm

NO INTERVENTION

observational study, no cohort, single group of different ages

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

Interventions

Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland)DEVICE

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)

one arm

Eligibility Criteria

Age11 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Study Officials

  • Ulrich Schiefer, Prof. Dr. med.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med Ulrich Schiefer

Study Record Dates

First Submitted

January 12, 2012

First Posted

January 26, 2012

Study Start

June 1, 2006

Primary Completion

March 1, 2008

Study Completion

September 1, 2008

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

DE(1)