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Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AcuFocus, Inc.
ClinicalTrials.gov Identifier:
NCT01352442
First received: May 10, 2011
Last updated: July 12, 2016
Last verified: July 2016
Results First Received: August 19, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Presbyopia
Intervention: Device: AcuFocus Corneal Inlay ACI 7000PDT

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
AcuFocus Corneal Inlay

The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.

AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay


Participant Flow:   Overall Study
    AcuFocus Corneal Inlay  
STARTED     151  
COMPLETED     130  
NOT COMPLETED     21  



  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.
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Reporting Groups
  Description
AcuFocus Corneal Inlay

The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.

AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay


Baseline Measures
    AcuFocus Corneal Inlay  
Number of Participants  
[units: participants]
  151  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     151  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  51  (4)  
Gender  
[units: participants]
 
Female     71  
Male     80  
Region of Enrollment  
[units: participants]
 
Austria     9  
Japan     9  
Singapore     8  
Philippines     26  
Turkey     36  
New Zealand     16  
Australia     26  
Spain     3  
Netherlands     6  
France     12  



  Outcome Measures
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1.  Primary:   Uncorrected Near Visual Acuity 20/32 or Better   [ Time Frame: 12 months ]

2.  Secondary:   Subjective Improvement in Near Visual Acuity as Measured by Subjective Questionnaire.   [ Time Frame: 12 months ]


  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
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  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: Eugenia Thomas, OD
Organization: AcuFocus, Inc.
phone: 949-585-9511
e-mail: ethomas@acufocus.com



Responsible Party: AcuFocus, Inc.
ClinicalTrials.gov Identifier: NCT01352442     History of Changes
Other Study ID Numbers: ACU-P10-020B
Study First Received: May 10, 2011
Results First Received: August 19, 2015
Last Updated: July 12, 2016
Health Authority: Austria: Ethikkommission