Clinical Evaluation of a Progressive Addition Lens (PAL)

Ziv Hospital100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Presbyopia

Interventions

Progressive Addition Lens (Shamir PrimeIITM) SpectaclesDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Subjective Evaluation of Visual Quality

Time frame: 2-3 weeks

Overall Subjective Feedback

Time frame: 2-3 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.