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

NCT01028378 | Completed Phase 3 Results

• 1 other identifier: T-CAT-001
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 10

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.

Conditions

Myopia; Hyperopia

Outcome Measures

Primary Outcomes (9)

• Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D

  12 month

• Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D

  12 month

• Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D

  12 month

• Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better

  12 month

• Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively

  12 month

• Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA)

  12 month

• Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/40

  12 month

• Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only)

  12 month

• Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively

  12 month

Study Arms (1)

Topography-guided LASIK

EXPERIMENTAL

Topography-guided LASIK for Myopia or Hyperopia

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

Interventions

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

Topography-guided LASIK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Clinical Research Consultants, Inc.: lead
• Alcon Research: collaborator
• WaveLight AG: collaborator

Study Sites (10)

Milauskas Eye Institute

La Quinta, California, 92253, United States

Location

Gordon & Weiss Vision Institute

San Diego, California, 92122, United States

Location

Woolfson Eye Institute

Atlanta, Georgia, 30328, United States

Location

Emory Vision

Atlanta, Georgia, 30342, United States

Location

Bond Eye Associates

Peoria, Illinois, 61614, United States

Location

Durrie Vision

Overland Park, Kansas, 66211, United States

Location

TLC Laser Eye Center

Greensboro, North Carolina, 27410, United States

Location

Memorial Eye Institute

Harrisburg, Pennsylvania, 17112, United States

Location

Laser Vision of Texas

Houston, Texas, 77027, United States

Location

International Eye Care Laser Center

Houston, Texas, 77079, United States

Location

MeSH Terms

Conditions

Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Barbara S. Fant, Pharm.D.
• Organization: Clinical Research Consultants, Inc.

bsfant@crc-regulatory.com

513-961-8200

Study Officials

• Doyle Stulting, M.D., Ph.D.

  Woolfson Eye Institute/Medical Monitor

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2012
• Last Updated: April 11, 2016
• Results First Posted: April 11, 2016

Record last verified: 2016-03

Locations

US (10)