NCT01068938

Brief Summary

The purpose of this study is to compare three perimetric techniques regarding progression of the visual field.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

5.1 years

First QC Date

February 16, 2010

Last Update Submit

December 19, 2016

Conditions

Keywords

visual fieldperimetryglaucoma progressiongridPOAG and glaucoma suspects with prostaglandin monotherapy

Outcome Measures

Primary Outcomes (1)

  • glaucoma progression

    6 month

Study Arms (1)

open angle glaucoma, glaucoma suspects

risk of progression, Latanoprost monotherapy

Device: three different perimeters: HFA, Octopus, MATRIX

Interventions

visual fields

open angle glaucoma, glaucoma suspects

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

University Eye Hospital

You may qualify if:

  • max. ± 8 dpt sph, max. ± 3 dpt cyl
  • distant visual acuity \> 10/20
  • isocoria, pupil diameter \> 3 mm
  • at least one risk of progression: optic disc (splinter) hemorrhage / cup to disc ratio (CDR) \> 0.7 / inter-eye asymmetry of CDR \>0.2 / notching of the optic disc /retinal nerve fibre layer (RNFL) defects / intraocular pressure( IOP) \>22 mmHg / central corneal thickness \< 520 µm / advanced visual field defect stage Aulhorn III / elder than 70 years

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
  • infections (e.g. keratitis, conjunctivitis, uveitis)
  • severe dry eyes
  • miotic drug
  • amblyopia
  • squint
  • nystagmus
  • albinism
  • any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields,disc imaging or accurate IOP readings
  • keratoconus
  • +6 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)

  • Schiefer U, Pascual JP, Edmunds B, Feudner E, Hoffmann EM, Johnson CA, Lagreze WA, Pfeiffer N, Sample PA, Staubach F, Weleber RG, Vonthein R, Krapp E, Paetzold J. Comparison of the new perimetric GATE strategy with conventional full-threshold and SITA standard strategies. Invest Ophthalmol Vis Sci. 2009 Jan;50(1):488-94. doi: 10.1167/iovs.08-2229. Epub 2008 Dec 5.

    PMID: 19060285BACKGROUND

Related Links

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Ulrich Schiefer, MD

    Centre for Ophthalmology, Institute for Ophthalmic Research

    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.

Study Record Dates

First Submitted

February 16, 2010

First Posted

February 17, 2010

Study Start

November 1, 2008

Primary Completion

December 1, 2013

Study Completion

December 1, 2016

Last Updated

December 20, 2016

Record last verified: 2016-12

Locations