PresbyopiaNCT01443585
Clinical Evaluation of a Progressive Addition Lens (PAL)
A study of Presbyopia, run by Ziv Hospital.
Trial summary
The purpose of the trial is to clinically evaluate the performance of a progressive addition lens among presbyopic patients. This evaluation will be done by performing visual tests and collecting subjective information from subjects wearing the lens which will be manufactured according to personal prescription. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Presbyopia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Nov 2013
- Phase
- Interventional
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An ability to comprehend and give an informed consent for participation in the trial
- Presbyopia
Who cannot join
- Concurrent participation in another clinical trial
- Age<18
- For female subjects: pregnancy \ planning a pregnancy \ lactating at the time of enrollment
- Imbalanced diabetes \ high blood pressure \ thyroid disease
- Infectious disease
- Inability (cognitively) to comprehend the instructions given during the trial and to comply with them
About this study
Official title: Clinical Performance Evaluation of a Progressive Addition Lens Among Presbyopic Patients
The purpose of the trial is to clinically evaluate the performance of a progressive addition lens among presbyopic patients.
This evaluation will be done by performing visual tests and collecting subjective information from subjects wearing the lens which will be manufactured according to personal prescription.
- Conditions
- Presbyopia
- Being tested
- Progressive Addition Lens (Shamir PrimeIITM) Spectacles
- Keywords
- Progressive Addition Lens, Multifocal, Presbyopia
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Addition Lens (Shamir PrimeIITM) SpectaclesDevice
A pair of progressive addition lenses manufactured according to the subject's personal prescription.
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal Intermediate Visual Field
Measured: Baseline
Visual Acuity
Measured: Baseline
Horizontal Near Visual Field
Measured: Baseline
Field of comfortable reading on a computer screen
Measured: Baseline
Horizontal Far Visual Field
Measured: Baseline
Secondary outcomes (2)
Subjective Evaluation of Visual Quality
Measured: 2-3 weeks
Overall Subjective Feedback
Measured: 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startSep 2012
- Primary completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yosef Pikel, M.D, Principal investigator, Ziv Medical Center, Zefat, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443585
- Sponsor's protocol ID
- PALsCTIL
- Status last verified
- Sep 2011
- First submitted
- 14 Sep 2011
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of a Progressive Addition Lens Among Presbyopic Patients
- ClinicalTrials.gov ID
- NCT01443585
- Acronym / sponsor ID
- PALsCTIL
- Conditions
- Presbyopia
- Keywords
- Progressive Addition Lens, Multifocal, Presbyopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Sep 2012
- Primary completion
- Nov 2013 (estimated)
- First posted
- 29 Sep 2011 (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.
The purpose of the trial is to clinically evaluate the performance of a progressive addition lens among presbyopic patients.
This evaluation will be done by performing visual tests and collecting subjective information from subjects wearing the lens which will be manufactured according to personal prescription.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- An ability to comprehend and give an informed consent for participation in the trial
- Presbyopia
Key exclusion criteria (6 listed)
- Concurrent participation in another clinical trial
- Age<18
- For female subjects: pregnancy \ planning a pregnancy \ lactating at the time of enrollment
- Imbalanced diabetes \ high blood pressure \ thyroid disease
- Infectious disease
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 |
|---|---|---|
| Progressive Addition Lens (Shamir PrimeIITM) SpectaclesA pair of progressive addition lenses manufactured according to the subject's personal prescription. | Device | – |
Primary outcome
Horizontal Intermediate Visual Field
Time frame: Baseline
Visual Acuity
Time frame: Baseline
Horizontal Near Visual Field
Time frame: Baseline
Field of comfortable reading on a computer screen
Time frame: Baseline
Horizontal Far Visual Field
Time frame: Baseline
2 secondary outcomes
Subjective Evaluation of Visual Quality
Time frame: 2-3 weeks
Overall Subjective Feedback
Time frame: 2-3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
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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.
Yosef Pikel, M.D principal investigator
Ziv Medical Center, Zefat, Israel
Questions about this trial
What is this clinical trial studying?
A study of Presbyopia, run by Ziv Hospital.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Horizontal Intermediate Visual Field (time frame: Baseline). The study lists 5 primary outcomes in all. 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 15 Mar 2013.