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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: Intervention Model: Single Group Assignment;   Masking: None (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
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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
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
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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.
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 
Overall Participants Analyzed 
[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
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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: 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