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

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.
 
ClinicalTrials.gov Identifier: NCT01028378
Recruitment Status : Completed
First Posted : December 9, 2009
Results First Posted : April 11, 2016
Last Update Posted : April 11, 2016
Sponsor:
Collaborators:
Alcon Research
WaveLight AG
Information provided by (Responsible Party):
Clinical Research Consultants, Inc.

Study Type Interventional
Study Design Allocation: N/A;   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
Enrollment 212
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topography-guided LASIK
Hide Arm/Group Description

Topography-guided LASIK for Myopia or Hyperopia

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

Period Title: Overall Study
Started 212 [1]
Completed 195 [2]
Not Completed 17
Reason Not Completed
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
Arm/Group Title Topography-guided LASIK
Hide Arm/Group Description

Topography-guided LASIK for Myopia or Hyperopia

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

Overall Number of Baseline Participants 212
Hide Baseline Analysis Population Description
212 participants (249 eyes)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 212 participants
34  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants
Female
93
  43.9%
Male
119
  56.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 212 participants
Caucasian 157
Black 4
Asian 8
Hispanic 37
Other 6
1.Primary Outcome
Title Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D
Hide Description [Not Specified]
Time Frame 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topography-guided LASIK
Hide Arm/Group Description:

Topography-guided LASIK for Myopia or Hyperopia

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

Overall Number of Participants Analyzed 195
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Eyes
230
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Eyes
94.78
(91.8 to 97.7)
2.Primary Outcome
Title Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D
Hide Description [Not Specified]
Time Frame 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topography-guided LASIK
Hide Arm/Group Description:

Topography-guided LASIK for Myopia or Hyperopia

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

Overall Number of Participants Analyzed 195
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Eyes
230
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Eyes
99.57
(98.7 to 100)
3.Primary Outcome
Title Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D
Hide Description [Not Specified]
Time Frame 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topography-guided LASIK
Hide Arm/Group Description:

Topography-guided LASIK for Myopia or Hyperopia

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

Overall Number of Participants Analyzed 195
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Eyes
230
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Eyes
100
(100 to 100)
4.Primary Outcome
Title Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better
Hide Description [Not Specified]
Time Frame 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topography-guided LASIK
Hide Arm/Group Description:

Topography-guided LASIK for Myopia or Hyperopia

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

Overall Number of Participants Analyzed 195
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Eyes
230
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Eyes
92.61
(89.2 to 96.1)
5.Primary Outcome
Title Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively
Hide Description [Not Specified]
Time Frame 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topography-guided LASIK
Hide Arm/Group Description:

Topography-guided LASIK for Myopia or Hyperopia

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

Overall Number of Participants Analyzed 195
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Eyes
230
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Eyes
99.56
(98.7 to 100)
6.Primary Outcome
Title Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA)
Hide Description [Not Specified]
Time Frame 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topography-guided LASIK
Hide Arm/Group Description:

Topography-guided LASIK for Myopia or Hyperopia

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

Overall Number of Participants Analyzed 195
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Eyes
230
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Eyes
0.43
(0 to 1.3)
7.Primary Outcome
Title Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/40
Hide Description [Not Specified]
Time Frame 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topography-guided LASIK
Hide Arm/Group Description:

Topography-guided LASIK for Myopia or Hyperopia

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

Overall Number of Participants Analyzed 195
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Eyes
230
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Eyes
0
(0 to 0)
8.Primary Outcome
Title Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only)
Hide Description [Not Specified]
Time Frame 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topography-guided LASIK
Hide Arm/Group Description:

Topography-guided LASIK for Myopia or Hyperopia

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

Overall Number of Participants Analyzed 195
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Eyes
230
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Eyes
0
(0 to 0)
9.Primary Outcome
Title Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively
Hide Description [Not Specified]
Time Frame 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topography-guided LASIK
Hide Arm/Group Description:

Topography-guided LASIK for Myopia or Hyperopia

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

Overall Number of Participants Analyzed 195
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Eyes
230
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Eyes
0
(0 to 0)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topography-guided LASIK
Hide Arm/Group Description

Topography-guided LASIK for Myopia or Hyperopia

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

All-Cause Mortality
Topography-guided LASIK
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Topography-guided LASIK
Affected / at Risk (%)
Total   0/195 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Topography-guided LASIK
Affected / at Risk (%)
Total   2/195 (1.03%) 
Eye disorders   
BSCVA loss of 2 or more lines   1/195 (0.51%) 
Retinal Detachments   1/195 (0.51%) 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Barbara S. Fant, Pharm.D.
Organization: Clinical Research Consultants, Inc.
Phone: 513-961-8200
EMail: bsfant@crc-regulatory.com
Layout table for additonal information
Responsible Party: Clinical Research Consultants, Inc.
ClinicalTrials.gov Identifier: NCT01028378    
Other Study ID Numbers: T-CAT-001
First Submitted: December 7, 2009
First Posted: December 9, 2009
Results First Submitted: January 28, 2014
Results First Posted: April 11, 2016
Last Update Posted: April 11, 2016