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Clinical Evaluation of a Progressive Addition Lens (PAL)

Clinical Performance Evaluation of a Progressive Addition Lens Among Presbyopic Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01443585
Enrollment
100
Registered
2011-09-29
Start date
2012-09-30
Completion date
Unknown
Last updated
2013-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia

Keywords

Progressive Addition Lens, Multifocal, Presbyopia

Brief 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.

Interventions

DEVICEProgressive Addition Lens (Shamir PrimeIITM) Spectacles

A pair of progressive addition lenses manufactured according to the subject's personal prescription.

Sponsors

Ziv Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* An ability to comprehend and give an informed consent for participation in the trial * Presbyopia

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Field of comfortable reading on a computer screenBaseline
Horizontal Intermediate Visual FieldBaseline
Visual AcuityBaseline
Horizontal Near Visual FieldBaseline
Horizontal Far Visual FieldBaseline

Secondary

MeasureTime frame
Overall Subjective Feedback2-3 weeks
Subjective Evaluation of Visual Quality2-3 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026