Clinical trial NCT01028378: Safety and Efficacy Study of Topography-Guided LASIK to Treat Myopia and Hyperopia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myopia
Hyperopia
Lead sponsor: Clinical Research Consultants, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Alcon Research
name: WaveLight AG
First posted: 2009-12-09
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D
timeFrame: 12 month
measure: Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D
timeFrame: 12 month
measure: Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D
timeFrame: 12 month
measure: Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better
timeFrame: 12 month
measure: Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively
timeFrame: 12 month
measure: Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA)
timeFrame: 12 month
measure: Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/40
timeFrame: 12 month
measure: Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only)
timeFrame: 12 month
measure: Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: La Quinta
country: United States
facility: Milauskas Eye Institute
state: California
city: San Diego
country: United States
facility: Gordon & Weiss Vision Institute
state: California
city: Atlanta
country: United States
facility: Woolfson Eye Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Vision
state: Georgia
city: Peoria
country: United States
facility: Bond Eye Associates
state: Illinois
city: Overland Park
country: United States
facility: Durrie Vision
state: Kansas
city: Greensboro
country: United States
facility: TLC Laser Eye Center
state: North Carolina
city: Harrisburg
country: United States
facility: Memorial Eye Institute
state: Pennsylvania
city: Houston
country: United States
facility: Laser Vision of Texas
state: Texas
city: Houston
country: United States
facility: International Eye Care Laser Center
state: Texas
Study officials:
affiliation: Woolfson Eye Institute/Medical Monitor
name: Doyle Stulting, M.D., Ph.D.
role: STUDY_DIRECTOR
References: