NCT01443585

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Last Updated

March 15, 2013

Status Verified

September 1, 2011

Enrollment Period

1.2 years

First QC Date

September 14, 2011

Last Update Submit

March 14, 2013

Conditions

Presbyopia

Keywords

Progressive Addition LensMultifocalPresbyopia

Outcome Measures

Primary Outcomes (5)

  • Horizontal Intermediate Visual Field

    Baseline

  • Visual Acuity

    Baseline

  • Horizontal Near Visual Field

    Baseline

  • Field of comfortable reading on a computer screen

    Baseline

  • Horizontal Far Visual Field

    Baseline

Secondary Outcomes (2)

  • Subjective Evaluation of Visual Quality

    2-3 weeks

  • Overall Subjective Feedback

    2-3 weeks

Interventions

Progressive Addition Lens (Shamir PrimeIITM) SpectaclesDEVICE

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Presbyopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Officials

  • Yosef Pikel, M.D

    Ziv Medical Center, Zefat, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 29, 2011

Study Start

September 1, 2012

Primary Completion

November 1, 2013

Last Updated

March 15, 2013

Record last verified: 2011-09