Clinical Evaluation of a Progressive Addition Lens (PAL) | NCT01443585

Studies
Clinical Evaluation of a Progressive Addition Lens (PAL)

NCT01443585

Sponsor

Ziv Hospital

Status

Unknown status

Last Update Posted

Mar 15, 2013Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Presbyopia

Interventions

Progressive Addition Lens (Shamir PrimeIITM) Spectacles

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Nov 2013Estimated

Completion Date

Not provided

First Submitted Date

Sep 14, 2011

First Submission Date that Met QC Criteria

Sep 28, 2011

First Posted Date

Sep 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2013

Last Update Posted Date

Mar 15, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Progressive Addition Lens (Shamir PrimeIITM) Spectacles	Device	A pair of progressive addition lenses manufactured according to the subject's personal prescription.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yosef Pikel, M.D	Ziv Medical Center, Zefat, Israel	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011305	Presbyopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005139	Eyeglasses

Ancestor Terms

ID	Term
D007909	Lenses
D055096	Optical Devices
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided