Age Related Macular DegenerationPHPNCT00692887
Correlation Between Visual Field Defects on Foresee Preferential Hyperacuity Perimeter(PHP) and on Optical Coherence Tomography (OCT) in Patients With Choroidal Neovascularization (CNV)
An observational study of Age Related Macular Degeneration, run by Notal Vision Ltd. at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- PHP - Preferential Hyperacuity Perimeter (Foresee)
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2008to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Subjects diagnosed as new CNV or treated CNV * Age >50 years * VA with habitual correction <20/160 in the study eye
Who may be able to join
- 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
Who cannot join
- 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)
- Participation in another study with the exclusion of AREDS study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Visual Field Defects on Foresee PHP and OCT in Patients With CNV Before and After Treatment
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.
Read the detailed description
The Foresee PHP is used in the recent years to detect Age-related Macular Degeneration (AMD) lesions. The device is capable of differentiation as to stages of AMD and early detection of changes including choroidal neovascularization (CNV) The Foresee PHP™ demonstrates a high level of sensitivity and specificity as to the different stages of AMD including newly diagnosed or early detection of CNV.
The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.
The Foresee PHP can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.
- Conditions
- Age Related Macular Degeneration
- Being tested
- PHP - Preferential Hyperacuity Perimeter (Foresee)
- Keywords
- AMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHP - Preferential Hyperacuity Perimeter (Foresee)Device
Also called PHP 2.0.5, OCT - optical coherence tomography
computerized test
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects diagnosed as new CNV or treated CNV Receives: Device: PHP - Preferential Hyperacuity Perimeter (Foresee) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 month
Secondary outcomes (1)
To investigate the Foresee PHP ability to asses treatment progression post treatment.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anat Loewenstein, Prof., Principal investigator, Sorasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692887
- Sponsor's protocol ID
- PHP-POST-01
- Acronym
- PHP
- Status last verified
- Jan 2009
- First submitted
- 26 May 2008
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Visual Field Defects on Foresee PHP and OCT in Patients With CNV Before and After Treatment
- ClinicalTrials.gov ID
- NCT00692887
- Acronym / sponsor ID
- PHP / PHP-POST-01
- Conditions
- Age Related Macular Degeneration
- Keywords
- AMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Foresee PHP is used in the recent years to detect Age-related Macular Degeneration (AMD) lesions. The device is capable of differentiation as to stages of AMD and early detection of changes including choroidal neovascularization (CNV) The Foresee PHP™ demonstrates a high level of sensitivity and specificity as to the different stages of AMD including newly diagnosed or early detection of CNV.
The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.
The Foresee PHP can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: PHP - Preferential Hyperacuity Perimeter (Foresee)Subjects diagnosed as new CNV or treated CNV |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Subjects diagnosed as new CNV or treated CNV * Age >50 years * VA with habitual correction <20/160 in the study eye
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
- Participation in another study with the exclusion of AREDS study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHP - Preferential Hyperacuity Perimeter (Foresee)Also: PHP 2.0.5, OCT - optical coherence tomographycomputerized test | Device | 1 |
Primary outcome
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).
Time frame: 6 month
1 secondary outcome
To investigate the Foresee PHP ability to asses treatment progression post treatment.
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
- sponsor web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anat Loewenstein, Prof. principal investigator
Sorasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration, run by Notal Vision Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2009.