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
  Purpose
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.

Condition Intervention Phase
Myopia
Hyperopia
Device: T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Clinical Research Consultants, Inc.:

Primary Outcome Measures:
  • Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA) [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/40 [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only) [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Enrollment: 212
Study Start Date: October 2009
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topography-guided LASIK
Topography-guided LASIK for Myopia or Hyperopia
Device: T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028378

Locations
United States, California
Milauskas Eye Institute
La Quinta, California, United States, 92253
Gordon & Weiss Vision Institute
San Diego, California, United States, 92122
United States, Georgia
Emory Vision
Atlanta, Georgia, United States, 30342
Woolfson Eye Institute
Atlanta, Georgia, United States, 30328
United States, Illinois
Bond Eye Associates
Peoria, Illinois, United States, 61614
United States, Kansas
Durrie Vision
Overland Park, Kansas, United States, 66211
United States, North Carolina
TLC Laser Eye Center
Greensboro, North Carolina, United States, 27410
United States, Pennsylvania
Memorial Eye Institute
Harrisburg, Pennsylvania, United States, 17112
United States, Texas
International Eye Care Laser Center
Houston, Texas, United States, 77079
Laser Vision of Texas
Houston, Texas, United States, 77027
Sponsors and Collaborators
Clinical Research Consultants, Inc.
Alcon Research
WaveLight AG
Investigators
Study Director: Doyle Stulting, M.D., Ph.D. Woolfson Eye Institute/Medical Monitor
  More Information

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

Additional relevant MeSH terms:
Myopia
Hyperopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 21, 2016