NCT01265628

Brief Summary

Comparison of the differential luminance sensitivity (DLS) values at each test point

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

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

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Last Updated

January 26, 2012

Status Verified

January 1, 2012

Enrollment Period

9 months

First QC Date

December 22, 2010

Last Update Submit

January 25, 2012

Conditions

Visual Field Defects

Outcome Measures

Primary Outcomes (1)

  • Validation of visual field data and comparison of the differential luminance sensitivity (DLS) values at each test point by applying two perimetric software versions.

    each participant were examined 2 times at two seperate sessions within 14 days.

    up to 14 days

Study Arms (3)

Glaucoma

Procedure: perimetry

Retinitis pigmentosa (RP)

Procedure: perimetry

Anterior Ischemic Optic Neuropathy (AION)

Procedure: perimetry

Interventions

perimetryPROCEDURE

automated static perimetry with adapted GATE strategy

Also known as: Octopus 900
Anterior Ischemic Optic Neuropathy (AION)GlaucomaRetinitis pigmentosa (RP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

selected from the eye hospital's database

You may qualify if:

  • physical, intellectual and linguistic abilities, in order to understand the test requirements
  • spherical ametropia max. ± 8 dpt, cylindrical ametropia max. ± 3 dpt
  • distant visual acuity \> 10/20
  • isocoria, pupil diameter \> 3 mm

You may not qualify if:

  • pregnancy, nursing
  • diabetic retinopathy
  • asthma
  • HIV+ or AIDS
  • history of epilepsy or significant psychiatric disease
  • medications known to effect visual field sensitivity
  • acute ocular infections (e.g. keratitis, conjunctivitis, uveitis)
  • severe dry eyes
  • miotic drugs
  • amblyopia
  • squint
  • nystagmus
  • albinism
  • keratoconus
  • intraocular surgery (except for uncomplicated cataract surgery) performed \< 3 month prior to screening
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Ophthalmology, Institute for Ophthalmic Research

Tübingen, 72076, Germany

Location

Related Publications (1)

  • Luithardt AF, Meisner C, Monhart M, Krapp E, Mast A, Schiefer U. Validation of a new static perimetric thresholding strategy (GATE). Br J Ophthalmol. 2015 Jan;99(1):11-5. doi: 10.1136/bjophthalmol-2013-304535. Epub 2014 Jul 22.

    PMID: 25053761DERIVED

Study Officials

  • Ulrich Schiefer, Prof.Dr.med.

    University of Tuebingen, Centre for Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Ulrich Schiefer

Study Record Dates

First Submitted

December 22, 2010

First Posted

December 23, 2010

Study Start

November 1, 2010

Primary Completion

August 1, 2011

Last Updated

January 26, 2012

Record last verified: 2012-01

Locations

DE(1)