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

December 7, 2009
March 18, 2016
October 2009
April 2012   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT01028378 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy Study of Topography-Guided LASIK to Treat Myopia and Hyperopia
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
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.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Myopia
  • Hyperopia
Device: T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
212
Not Provided
April 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01028378
T-CAT-001
No
Not Provided
Not Provided
Clinical Research Consultants, Inc.
Clinical Research Consultants, Inc.
  • Alcon Research
  • WaveLight AG
Study Director: Doyle Stulting, M.D., Ph.D. Woolfson Eye Institute/Medical Monitor
Clinical Research Consultants, Inc.
March 2016

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