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Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle (CZV_PAL1)

This study has been completed.
Sponsor:
Collaborator:
Carl Zeiss Meditec, Inc.
Information provided by (Responsible Party):
Meng C. Lin, University of California, Berkeley
ClinicalTrials.gov Identifier:
NCT01234207
First received: November 3, 2010
Last updated: April 17, 2017
Last verified: April 2017
Results First Received: June 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Presbyopia
Interventions: Device: Standard, non-free-form, non-customized PAL spectacles
Device: Individually customized free-form surfaced PAL spectacles

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Presbyopic subjects were recruited from the population of patients who were purchasing non-free-form PAL spectacles with antireflective coating in new frames from the University of California, Berkeley School of Optometry Eyewear Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
95 subjects were recruited, all of whom met the eligibility criteria and completed the study.

Reporting Groups
  Description
Group 1 - Control Spectacles Worn First, Then Test Spectacles Crossover trial; 2 arms: subjects randomized to wear Control spectacles 1st, then Test spectacles 2nd
Group 2 - Test Spectacles Worn First, Then Control Spectacles Crossover trial; 2 arms: subjects randomized to wear Test spectacles 1st, then Control spectacles 2nd

Participant Flow for 3 periods

Period 1:   First Intervention
    Group 1 - Control Spectacles Worn First, Then Test Spectacles   Group 2 - Test Spectacles Worn First, Then Control Spectacles
STARTED   47   48 
COMPLETED   47   48 
NOT COMPLETED   0   0 

Period 2:   1-Week Washout Period
    Group 1 - Control Spectacles Worn First, Then Test Spectacles   Group 2 - Test Spectacles Worn First, Then Control Spectacles
STARTED   47   48 
COMPLETED   47   48 
NOT COMPLETED   0   0 

Period 3:   Second Intervention
    Group 1 - Control Spectacles Worn First, Then Test Spectacles   Group 2 - Test Spectacles Worn First, Then Control Spectacles
STARTED   47   48 
COMPLETED   47   48 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study Participants Crossover trial: all study participants received both Test and Control spectacles, in randomized order.

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 95 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      80  84.2% 
>=65 years      15  15.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.1  (6.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      57  60.0% 
Male      38  40.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   1.1% 
Asian      12  12.6% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      3   3.2% 
White      73  76.8% 
More than one race      0   0.0% 
Unknown or Not Reported      6   6.3% 
Region of Enrollment 
[Units: Participants]
 
United States   95 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Visual Acuity, High Contrast, Distance Chart   [ Time Frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles ]

2.  Primary:   Visual Acuity, Low Contrast, Distance Chart   [ Time Frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles ]

3.  Primary:   Visual Acuity, High Contrast, Near Chart   [ Time Frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles ]

4.  Primary:   Visual Acuity, Low Contrast, Near Chart   [ Time Frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles ]

5.  Primary:   30-degree Off-axis Distance Visual Acuity, High Contrast Chart   [ Time Frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles ]

6.  Primary:   30-degree Off-axis Distance Visual Acuity, Low Contrast Chart   [ Time Frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles ]

7.  Primary:   Horizontal Extent of Undistorted Vision at Reading Distance   [ Time Frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles ]

8.  Primary:   Questionnaire Battery   [ Time Frame: At study exit, after both Test and Control spectacles had been worn for 1 week each ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Possibility of insufficient head immobilization during off-axis VA measurement on left side only for some subjects. May explain difference of off-axis VA results between right and left sides.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Andrew D. Graham
Organization: UCaliforniaBerkeley
phone: 510-643-9252
e-mail: agraham@berkeley.edu


Publications of Results:

Responsible Party: Meng C. Lin, University of California, Berkeley
ClinicalTrials.gov Identifier: NCT01234207     History of Changes
Other Study ID Numbers: CZV_PAL1
Study First Received: November 3, 2010
Results First Received: June 27, 2013
Last Updated: April 17, 2017