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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00358345
Other study ID # PHP C9
Secondary ID
Status Completed
Phase Phase 4
First received July 27, 2006
Last updated January 10, 2008
Start date October 2003
Est. completion date September 2007

Study information

Verified date January 2008
Source Notal Vision Ltd
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

The primary objective of this study is to assess the ability of the PreView PHP(study device)to detect newly diagnosed non-treated Choroidal Neovascularization (CNV)lesion associate with advanced Age-related Macular Degeneration (AMD) or Myopia and differentiate them from Intermediate AMD or Geographic Atrophy (GA)or patients with high Myopia with no CNV.

This study secondary is to enhance NotalVision normative database.


Description:

- The study is prospective, multi-center, comparative study.

- A clinical trail with FDA approval device (510K).


Recruitment information / eligibility

Status Completed
Enrollment 347
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Newly diagnosed (up yo 2 months) CNV OR Intermediate AMD

- Age >50 for AMD subjects

- Age >18 for Myopic subjects

- VA 20/160 or better in the study eye

- Mental and physical ability to performed a PHP test

Exclusion Criteria:

- Evidence of macular disease other than AMD or high myopia in the study eye.

- Previous surgical or laser treatment within the macular erea.

- Concurrent intraocular drug therapy (within 30 days).

- Present of any significant media opacity that preclude a clear veiw of the macula.

- Any non macular related ocular surgery performed within 3 months prior to the study.

- CNV subjects inability to tolerate intravenous fluorscien angiography.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Israel Tel Aviv Sourasky medical center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Notal Vision Ltd

Country where clinical trial is conducted

Israel, 

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