NCT00692887

Brief Summary

Study come to investigate the correlation between visual fields (VF) defects map generated by preferential hyperacuity perimeter (PHP) and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT). To investigate the Foresee PHP ability to asses treatment progression post treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2008

Shorter than 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

First Submitted

Initial submission to the registry

May 26, 2008

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 28, 2009

Status Verified

January 1, 2009

Enrollment Period

6 months

First QC Date

May 26, 2008

Last Update Submit

January 27, 2009

Conditions

Keywords

AMD

Outcome Measures

Primary Outcomes (1)

  • To investigate the correlation between visual fields (VF) defects map generated by preferential hyperacuity perimeter (PHP) and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT).

    6 month

Secondary Outcomes (1)

  • To investigate the Foresee PHP ability to asses treatment progression post treatment.

    6 month

Study Arms (1)

1

Subjects diagnosed as new CNV or treated CNV

Device: PHP - Preferential Hyperacuity Perimeter (Foresee)

Interventions

computerized test

Also known as: PHP 2.0.5, OCT - optical coherence tomography
1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Subjects diagnosed as new CNV or treated CNV * Age \>50 years * VA with habitual correction \<20/160 in the study eye

You may qualify if:

  • Capable and willing to sign a consent form and participate in the study
  • Subjects diagnosed as new CNV or treated CNV
  • Age \>50 years
  • VA with habitual correction \<20/160 in the study eye
  • Ability to understand instructions

You may not qualify if:

  • Evidence of macular disease other than AMD or glaucoma in the study eye
  • Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy,
  • Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
  • Patients diagnosed with geographic atrophy (GA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sorasky Medical center

Tel Aviv, Israel

Location

Related Links

MeSH Terms

Conditions

Macular Degeneration

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Anat Loewenstein, Prof.

    Sorasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 26, 2008

First Posted

June 6, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

January 28, 2009

Record last verified: 2009-01

Locations