Clinical Evaluation of a Progressive Addition Lens (PAL)

March 14, 2013 updated by: Ziv Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Horizontal Intermediate Visual Field
Time Frame: Baseline
Baseline
Visual Acuity
Time Frame: Baseline
Baseline
Horizontal Near Visual Field
Time Frame: Baseline
Baseline
Field of comfortable reading on a computer screen
Time Frame: Baseline
Baseline
Horizontal Far Visual Field
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective Evaluation of Visual Quality
Time Frame: 2-3 weeks
2-3 weeks
Overall Subjective Feedback
Time Frame: 2-3 weeks
2-3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziv Hospital

Investigators

  • Principal Investigator: Yosef Pikel, M.D, Ziv Medical Center, Zefat, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

September 14, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 29, 2011

Study Record Updates

Last Update Posted (Estimate)

March 15, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PALsCTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Presbyopia

Clinical Trials on Progressive Addition Lens (Shamir PrimeIITM) Spectacles

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe