Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Safety and Efficacy Study of Topography-Guided LASIK to Treat Myopia and Hyperopia

This study has been completed.
Sponsor:
Collaborators:
Alcon Research
WaveLight AG
Information provided by (Responsible Party):
Clinical Research Consultants, Inc.
ClinicalTrials.gov Identifier:
NCT01028378
First received: December 7, 2009
Last updated: March 18, 2016
Last verified: March 2016
Results First Received: January 28, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Myopia
Hyperopia
Intervention: Device: T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Topography-guided LASIK

Topography-guided LASIK for Myopia or Hyperopia

T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser


Participant Flow:   Overall Study
    Topography-guided LASIK  
STARTED     212 [1]
COMPLETED     195 [2]
NOT COMPLETED     17  
Lost to Follow-up                 12  
Withdrawal by Subject                 1  
Adminstrative Reasons                 4  
[1] 212 participants (249 eyes) with myopia
[2] 195 participants (230 eyes) with myopia



  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.
212 participants (249 eyes)

Reporting Groups
  Description
Topography-guided LASIK

Topography-guided LASIK for Myopia or Hyperopia

T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser


Baseline Measures
    Topography-guided LASIK  
Number of Participants  
[units: participants]
  212  
Age  
[units: years]
Mean (Standard Deviation)
  34  (9.3)  
Gender  
[units: participants]
 
Female     93  
Male     119  
Race/Ethnicity, Customized  
[units: participants]
 
Caucasian     157  
Black     4  
Asian     8  
Hispanic     37  
Other     6  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D   [ Time Frame: 12 month ]

2.  Primary:   Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D   [ Time Frame: 12 month ]

3.  Primary:   Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D   [ Time Frame: 12 month ]

4.  Primary:   Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better   [ Time Frame: 12 month ]

5.  Primary:   Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively   [ Time Frame: 12 month ]

6.  Primary:   Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA)   [ Time Frame: 12 month ]

7.  Primary:   Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/40   [ Time Frame: 12 month ]

8.  Primary:   Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only)   [ Time Frame: 12 month ]

9.  Primary:   Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively   [ Time Frame: 12 month ]


  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
No text entered.


  More Information
  Hide More Information

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: Barbara S. Fant, Pharm.D.
Organization: Clinical Research Consultants, Inc.
phone: 513-961-8200
e-mail: bsfant@crc-regulatory.com



Responsible Party: Clinical Research Consultants, Inc.
ClinicalTrials.gov Identifier: NCT01028378     History of Changes
Other Study ID Numbers: T-CAT-001
Study First Received: December 7, 2009
Results First Received: January 28, 2014
Last Updated: March 18, 2016
Health Authority: United States: Food and Drug Administration