Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses

This study has been terminated.
(Terminated due to low enrollment)
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01241279
First received: November 12, 2010
Last updated: November 25, 2014
Last verified: November 2014
Results First Received: May 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Cataract
Interventions: Device: Crystalens AO
Device: SoftPort LI61AO

  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
A total of 6 subjects (11 eyes) were enrolled at one investigational site in the US. First participant enrolled 10/26/2010; last participant visit 12/01/2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Due to the small sample size, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.

Reporting Groups
  Description
Crystalens AO A silicone multi-piece accommodating intraocular lens
SoftPort LI61AO A silicone multi-piece foldable aspheric intraocular lens

Participant Flow:   Overall Study
    Crystalens AO     SoftPort LI61AO  
STARTED     4     2  
COMPLETED     4     1  
NOT COMPLETED     0     1  
Lost to Follow-up                 0                 1  



  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
Crystalens AO A silicone multi-piece accommodating intraocular lens
SoftPort LI61AO A silicone multi-piece foldable aspheric intraocular lens
Total Total of all reporting groups

Baseline Measures
    Crystalens AO     SoftPort LI61AO     Total  
Number of Participants  
[units: participants]
  4     2     6  
Age, Customized  
[units: participants]
     
Age 54 to 70 years     4     2     6  
Gender  
[units: participants]
     
Female     2     1     3  
Male     2     1     3  



  Outcome Measures
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1.  Primary:   Amplitude of Accommodation   [ Time Frame: Visit 4 (postoperative day 120-180) ]

2.  Secondary:   Visual Acuity   [ Time Frame: All visits through visit 4 (day 160-180) ]


  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
Study terminated early due to lack of enrollment


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Johnson Varughese
Organization: Valeant Pharmaceuticals/Bausch & Lomb
phone: 908-927-1162
e-mail: Johnson.Varughese@valeant.com


No publications provided


Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01241279     History of Changes
Other Study ID Numbers: 657
Study First Received: November 12, 2010
Results First Received: May 17, 2013
Last Updated: November 25, 2014
Health Authority: United States: Food and Drug Administration