Clinical Evaluation of a Progressive Addition Lens (PAL)

Presbyopia Clinical Trial

Official title:

Clinical Performance Evaluation of a Progressive Addition Lens Among Presbyopic Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01443585
• Other study ID #: PALsCTIL
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 14, 2011
• Last updated: March 14, 2013
• Start date: September 2012

Study information

• Verified date: September 2011
• Source: Ziv Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Progressive Addition Lens (Shamir PrimeIITM) Spectacles
A pair of progressive addition lenses manufactured according to the subject's personal prescription.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Horizontal Intermediate Visual Field		Baseline	No
Primary	Visual Acuity		Baseline	No
Primary	Horizontal Near Visual Field		Baseline	No
Primary	Field of comfortable reading on a computer screen		Baseline	No
Primary	Horizontal Far Visual Field		Baseline	No
Secondary	Subjective Evaluation of Visual Quality		2-3 weeks	No
Secondary	Overall Subjective Feedback		2-3 weeks	No