Clinical Evaluation of a Progressive Addition Lens (PAL)

• Sponsor: Ziv Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01443585
• Collaborator: (none)
• Enrollment: 100

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Device: Progressive Addition Lens (Shamir PrimeIITM) Spectacles	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Performance Evaluation of a Progressive Addition Lens Among Presbyopic Patients
• Study Start Date: Sep 1, 2012
• Anticipated Primary Completion Date: Nov 1, 2013

Outcome Measures

Primary Outcome Measures

1. Horizontal Intermediate Visual Field [Baseline]

2. Visual Acuity [Baseline]

3. Horizontal Near Visual Field [Baseline]

4. Field of comfortable reading on a computer screen [Baseline]

5. Horizontal Far Visual Field [Baseline]

Secondary Outcome Measures

1. Subjective Evaluation of Visual Quality [2-3 weeks]

2. Overall Subjective Feedback [2-3 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ziv Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ziv Hospital
• ClinicalTrials.gov Identifier: NCT01443585
• Other Study ID Numbers: PALsCTIL
• First Posted: Sep 29, 2011
• Last Update Posted: Mar 15, 2013
• Last Verified: Sep 1, 2011

• Keywords provided by Ziv Hospital: Progressive Addition Lens; Multifocal; Presbyopia
• Additional relevant MeSH terms: Presbyopia

Study Results

No Results Posted as of Mar 15, 2013