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Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01225952
First received: October 19, 2010
Last updated: December 11, 2012
Last verified: December 2012
Results First Received: August 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cataract
Interventions: Device: Crystalens AO
Device: ReSTOR 3.0
Device: AMO Tecnis Multifocal

  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
This study was an evaluation of three United States Food and Drug Administration (FDA) approved IOLs. A total of 93 participants(186 eyes) were enrolled at one investigative site in the Philippines. First participant was enrolled 7/15/2010 and last participant exited the study 4/28/2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
186 participant eyes were enrolled in this study 154 participant eyes completed the study. Participants underwent bilateral phacoemulsification and IOL implantation. Participants were randomized to treatment groups prior to surgery.

Reporting Groups
  Description
Crystalens AO Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
ReSTOR 3.0 An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
AMO Tecnis Multifocal A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL

Participant Flow:   Overall Study
    Crystalens AO     ReSTOR 3.0     AMO Tecnis Multifocal  
STARTED     31     31     31  
COMPLETED     25     27     25  
NOT COMPLETED     6     4     6  
Lost to Follow-up                 1                 0                 0  
Study Eye Explanted                 0                 0                 1  
Withdrawal by Subject                 4                 4                 5  
Surgical complications                 1                 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
Crystalens AO Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
ReSTOR 3.0 An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
AMO Tecnis Multifocal A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Total Total of all reporting groups

Baseline Measures
    Crystalens AO     ReSTOR 3.0     AMO Tecnis Multifocal     Total  
Number of Participants  
[units: participants]
  31     31     31     93  
Age, Customized  
[units: participants]
       
< 40 years     0     0     0     0  
40 - 49 years     2     1     0     3  
50 - 59 years     6     8     7     21  
60 - 69 years     13     14     16     43  
70 - 79 years     10     8     7     25  
>/= 80 years     0     0     1     1  
Gender  
[units: participants]
       
Female     23     25     22     70  
Male     8     6     9     23  
Region of Enrollment  
[units: participants]
       
Philippines     31     31     31     93  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)   [ Time Frame: Postoperative visit 3 (day 30-60) ]

2.  Primary:   Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)   [ Time Frame: Postoperative visit 3 (day 30-60) ]

3.  Primary:   Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)   [ Time Frame: Postoperative visit 3 (day 30-60) ]

4.  Primary:   Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)   [ Time Frame: Postoperative visit 3 (day 30-60) ]

5.  Primary:   Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)   [ Time Frame: Postoperative visit 4 (day 120-180) ]

6.  Primary:   Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)   [ Time Frame: Postoperative visit 4 (day 120-180) ]

7.  Primary:   Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)   [ Time Frame: Postoperative visit 4 (day 120-180) ]

8.  Primary:   Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)   [ Time Frame: Postoperative visit 4 (day 120-180) ]

9.  Secondary:   Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)   [ Time Frame: Postoperative visit 3 (day 30-60) ]

10.  Secondary:   Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)   [ Time Frame: Postoperative visit 3 (day 30-60) ]

11.  Secondary:   Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)   [ Time Frame: Postoperative visit 3 (day 30-60) ]

12.  Secondary:   Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)   [ Time Frame: Postoperative visit 3 (day 30-60) ]

13.  Secondary:   Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)   [ Time Frame: Postoperative visit 4 (day 120-180) ]

14.  Secondary:   Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)   [ Time Frame: Postoperative visit 4 (day 120-180) ]

15.  Secondary:   Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)   [ Time Frame: Postoperative visit 4 (day 120-180) ]

16.  Secondary:   Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)   [ Time Frame: Postoperative visit 4 (day 120-180) ]

17.  Secondary:   Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)   [ Time Frame: Postoperative visit 3 (day 30-60) ]

18.  Secondary:   Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree)   [ Time Frame: Postoperative visit 3 (day 30-60) ]

19.  Secondary:   Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)   [ Time Frame: Postoperative visit 3 (day 30-60) ]

20.  Secondary:   Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)   [ Time Frame: Postoperative visit 3 (day 30-60) ]

21.  Secondary:   Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)   [ Time Frame: Postoperative visit 3 (day 30-60) ]

22.  Secondary:   Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)   [ Time Frame: Postoperative visit 4 (day 120-180) ]

23.  Secondary:   Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree)   [ Time Frame: Postoperative visit 4 (day 120-180) ]

24.  Secondary:   Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)   [ Time Frame: Postoperative visit 4 (day 120-180) ]

25.  Secondary:   Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)   [ Time Frame: Postoperative visit 4 (day 120-180) ]

26.  Secondary:   Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)   [ Time Frame: Postoperative visit 4 (day 120-180) ]


  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
No text entered.


  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: Omid Khodai, OD,RAC
Organization: Bausch & Lomb Incorporated
phone: (949) 521-7894
e-mail: omid.khodai@bausch.com


No publications provided


Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01225952     History of Changes
Other Study ID Numbers: 656
Study First Received: October 19, 2010
Results First Received: August 31, 2012
Last Updated: December 11, 2012
Health Authority: United States: Food and Drug Administration
Philippines: Bureau of Food and Drugs