We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01069172
First Posted: February 17, 2010
Last Update Posted: September 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abbott Medical Optics
Results First Submitted: June 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cataract
Interventions: Device: FS Laser Surgery
Procedure: CCC Surgery

  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
Subjects served as their own control. Subjects were to have FS laser surgery in one eye (FS surgery eyes) and CCC with U/S surgery in their fellow eye (CCC surgery eyes). Assignment to one of the two surgery groups (FS or CCC) was randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
30 subjects were included in the study, but one subject withdrew prior to surgery on their second eye. Baseline and outcome measure analysis was performed on the 29 subjects with both eyes enrolled. Of these 29 subjects, all had FS laser surgery in one eye (29 FS surgery eyes) and CCC with U/S surgery in their fellow eye (29 CCC surgery eyes).

Reporting Groups
  Description
FS Laser Surgery

For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.

FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery.

CCC Surgery

Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC)

CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens.


Participant Flow:   Overall Study
    FS Laser Surgery   CCC Surgery
STARTED   30 [1]   30 [1] 
COMPLETED   29 [2]   30 [1] 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 
[1] 30 eyes
[2] 29 eyes



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Baseline analysis population consists of the 29 subjects that had both eyes enrolled. Of these 29 subjects, all had FS laser surgery in one eye (29 FS surgery eyes) and CCC with U/S surgery in their fellow eye (29 CCC surgery eyes).

Reporting Groups
  Description
FS Laser Surgery and CCC Surgery

Each eye underwent either:

  1. Femtosecond assissisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device (the Catalys System is used for FS Laser Surgery and is an ophthalmic surgical laser system intended for use in cataract surgery).

    OR

  2. Ultrasound (U/S) cataract surgery and CCC (continuous curvilinear capsulorhexis), subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens.

Baseline Measures
   FS Laser Surgery and CCC Surgery 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.1  (5.90) 
Gender 
[Units: Participants]
 
Female   17 
Male   12 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Deviation From Intended Capsulotomy Diameter   [ Time Frame: Day of Surgery ]

2.  Secondary:   Cumulative Dissipated Energy (CDE)   [ Time Frame: Day of Surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
This evaluation was performed on a relatively small number of patients; assessment of CDE should be repeated in a larger number of subjects.


  More Information
  Hide More Information

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: Luis Atiles, Manager, Clinical Research
Organization: AMO Development, LLC
phone: 214 537-6784
e-mail: luis.atiles@amo.abbott.com



Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01069172     History of Changes
Other Study ID Numbers: OMC-C-2.0
First Submitted: February 13, 2010
First Posted: February 17, 2010
Results First Submitted: June 17, 2014
Results First Posted: September 4, 2014
Last Update Posted: September 4, 2014