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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.

Tracking Information
First Submitted Date  ICMJE December 7, 2009
First Posted Date  ICMJE December 9, 2009
Results First Submitted Date  ICMJE January 28, 2014
Results First Posted Date  ICMJE April 11, 2016
Last Update Posted Date April 11, 2016
Study Start Date  ICMJE October 2009
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
  • Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D [ Time Frame: 12 month ]
  • Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D [ Time Frame: 12 month ]
  • Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D [ Time Frame: 12 month ]
  • Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better [ Time Frame: 12 month ]
  • Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively [ Time Frame: 12 month ]
  • Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA) [ Time Frame: 12 month ]
  • Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/40 [ Time Frame: 12 month ]
  • Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only) [ Time Frame: 12 month ]
  • Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively [ Time Frame: 12 month ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Topography-Guided LASIK to Treat Myopia and Hyperopia
Official Title  ICMJE Topography-Guided LASIK Using the ALLEGRETTO WAVE Eye-Q 400 Hz Excimer Laser System For the Treatment of Manifest and Cornea Based Myopic and Hyperopic Optical Errors
Brief Summary This purpose of this study is to evaluate the safety and effectiveness of a topography-based custom ablation treatment using the ALLEGRETTO WAVE® Eye-Q 400 Hz laser system for treating myopia and hyperopia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myopia
  • Hyperopia
Intervention  ICMJE Device: T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Study Arms  ICMJE Experimental: Topography-guided LASIK
Topography-guided LASIK for Myopia or Hyperopia
Intervention: Device: T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2016)
212
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or older;
  • Signed Informed Consent;
  • Willingness and ability to comply with schedule for follow-up visits;
  • be a candidate for topography guided LASIK treatment of myopia or hyperopia in both eyes based on your doctors examination of your eyes;
  • Intended treatment is targeted for emmetropia;
  • Stable refraction (0.5 D or less change in manifest refraction spherical equivalent (MRSE) per year) for 12 months or longer, based on previous clinical records or prescription history (e.g., old glasses/contact lens prescriptions).
  • Able to obtain a reliable corneal topography that can be used to determine the T-CAT treatment plan;
  • Best spectacle-corrected visual acuity (BSCVA) 20/25 or better in each eye;
  • Less than 0.75 D spherical equivalent (SE) difference between cycloplegic and manifest refractions.
  • Is not a contact lens wearer or, if wearing contact lenses, has discontinued wearing contact lenses for the required period of time and completed the contact lens stability check;
  • be able to maintain your eye position steady during the course of the treatment.

Exclusion Criteria:

  • History of prior refractive treatment;
  • Mixed astigmatism refractive error;
  • Lenticular astigmatism that, in the investigator's opinion, is clinically significant;
  • Corneal topography showing evidence of keratoconus, keratoconus suspect, forme fruste keratoconus, pellucid marginal degeneration, or other topographic abnormality that would place the eye at risk for developing post-refractive corneal ectasia;
  • Treatment plan for T-CAT would predict a residual stromal bed thickness less than 250 microns;
  • History or current evidence of corneal or other anterior segment disease that might reasonably be expected to affect the outcome of treatment (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.);
  • Evidence of retinal vascular disease;
  • Female patients who are pregnant or lactating or plan to become pregnant during the course of the study;
  • A known sensitivity to study medications;
  • Nystagmus or any other condition that would prevent a steady gaze during the LASIK treatment or other diagnostic tests;
  • Corneal dystrophy or corneal guttae;
  • Pathology involving the iris (e.g., coloboma, tears, cuts, significant pigment loss, etc.);
  • Residual, recurrent or active ocular pathology;
  • Previous intraocular or corneal surgery that might confound the outcome or increase the risk of the study;
  • Acute or chronic illness that might increase the risk or confound the outcome of the study (e.g., diagnosed autoimmune disease, systemic connective tissue disease, clinically significant atopic disease, diabetes mellitus, etc.)
  • The use of systemic medications that may confound the outcome or increase the risk of the study, including, but not limited to: corticosteroids and antimetabolites;
  • Intraocular pressure > 23 mm Hg, a history of glaucoma, or a glaucoma suspect;
  • An increased risk for developing strabismus after treatment (applicable only to treatment of hyperopic refractive errors);
  • Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for LASIK or study participation or may confound the outcome of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01028378
Other Study ID Numbers  ICMJE T-CAT-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinical Research Consultants, Inc.
Study Sponsor  ICMJE Clinical Research Consultants, Inc.
Collaborators  ICMJE
  • Alcon Research
  • WaveLight AG
Investigators  ICMJE
Study Director: Doyle Stulting, M.D., Ph.D. Woolfson Eye Institute/Medical Monitor
PRS Account Clinical Research Consultants, Inc.
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP