Comparison of Visual Fields: Humphrey Field Analyzer (HFA... | NCT01068938

Studies
Comparison of Visual Fields: Humphrey Field Analyzer (HFA) SITA Strategy, SCOPE (GATE Strategy) and Humphrey MATRIX Perimeter

NCT01068938

Sponsor

University Hospital Tuebingen

Status

Unknown status

Last Update Posted

Dec 20, 2016Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Glaucoma

Interventions

three different perimeters: HFA, Octopus, MATRIX

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
116MIR08023	Other Grant/Funding Number	Pfizer
428/2008BO1	Other Identifier	Ethics Committee University Hospital Tübingen

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2016Estimated

First Submitted Date

Feb 16, 2010

First Submission Date that Met QC Criteria

Feb 16, 2010

First Posted Date

Feb 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2016

Last Update Posted Date

Dec 20, 2016Estimated

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
open angle glaucoma, glaucoma suspects		risk of progression, Latanoprost monotherapy	Device: three different perimeters: HFA, Octopus, MATRIX

Interventions

Name	Type	Description	Arm Group Labels	Other Names
three different perimeters: HFA, Octopus, MATRIX	Device	visual fields	open angle glaucoma, glaucoma suspects

Measure	Description	Time Frame
glaucoma progression		6 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
intraocular surgery (except for uncomplicated cataract surgery) performed < 3 month prior to screening
history or signs of any visual pathway affection other than glaucoma
allergies with regard to topic glaucoma medication
history or presence of macular disease and / or macular edema
ocular trauma
medications known to affect visual field sensitivity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

University Eye Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulrich Schiefer, MD	Centre for Ophthalmology, Institute for Ophthalmic Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Ophthalmology, Institute for Ophthalmic Research		Tübingen		72076	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19060285	Background	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.

ID	Term
D005901	Glaucoma
D005902	Glaucoma, Open-Angle

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases