Allegretto Wave FDA Test Results-Summarized

Allegretto Wave Excimer Laser System: FDA Test Results

Device Trade Name: Wavelight Allegretto Wave Excimer Laser System
Applicant: Surgi Vision Refractive Consultants, North Reading, MA, USA.
Approved By The FDA: Oct 10, 2003

The Wavelight Allegretto Wave excimer laser system is intended for Lasik Assisted in situ Keratomileusis (LASIK) treatments for:

*The reduction or elimination of hyperopic refractive errors up to +6.0 diopters of sphere with and without astigmatic refractive errors up to 5.0 diopters at the spectacle plane;

*Patients who are 18 years of age or older;

*Patients with documentation of a stable refraction over one year prior to surgery.

The Allegretto Wave laser system has been commercially distributed in approximately 31 countries (Austria, Australia, Bahrain, Belgium, Brazil, Canada, China, France, Germany, Great Britain, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Mexico,

Summary Of Clinical Studies:
The sponsor performed a clinical study of the WaveLight Allegretto Wave Excimer Laser System at ten U.S. clinical sites.
A. Study Objective
The objective of the study was to determine the safety and effectiveness of the WaveLight Allegretto Wave Excimer Laser System for LASIK treatment of hyperopic refractive errors.
B. Study Design
The study was prospective, non-randomized, and involved 10 lasers centers, and 11 surgeons. Subjects were evaluated preoperatively and postoperatively at 1 day, 1 month, 3 months, 6 months, 9 months, 1 year, 18 months and 2 years.

	Worse %	No Change %	Better %
Glare From Bright Lights	10.9	62.9	26.1
Halos	13.3	68.6	18.2
Light Sensitivity	12.9	67.4	19.7
Visual Fluctuations	29.5	62.5	8.0
Night Driving Glare	16.0	61.2	22.8

Complications:	1 Month (%):	3 Months (%):	6 Months (%):	1 Year (%):
Corneal Edema Between 1 Week And 1 Month After Procedure	0.0	0.0	0.0	0.0
Corneal Epithelial Defect At 1 Month Or Later	0.0	0.4	0.8	0.0
Any Epithelium In The Interface	1.1	0.7	0.8	0.0
Foreign Body Sensations At 1 Month Or Later	0.0	0.0	0.0	0.0
Pain At 1 Month Or Later	1.8	0.0	0.0	0.0
Ghosting Or Double Images	0.0	0.0	0.0	0.0
Need For Lifting And/Or Reseating Of The Flap/Cap	0.0	0.0	0.0	0.0

Change In Patient Symptoms At 6 Months
(Compared With Pre-Operative Symptoms)

Patient Satisfaction:

Subjects were asked to complete a patient questionnaire preoperatively and at 3 months, 6 months, and 1 year postoperatively. These are the results for month 6:

Conclusions Drawn From The Clinical Study:

The data in the application support reasonable assurance of the safety and effectiveness of this device when used in accordance with the approved indications for use. The FDA approved the Allegretto Wave on Oct 10, 2003.

Netherlands, Norway, Russia, Saudi Arabia, Singapore, Slovenia, Spain, Sri Lanka, Sweden and Switzerland). The WaveLight Allegretto Wave has not been withdrawn from any country or market for reasons of safety or effectiveness of the device.

Of the total 290 eyes treated in the study, 16 eyes were retreated with the study laser due primarily to undercorrection. One eye was retreated for overcorrection.

Patient Complications Encountered:

Demographics:
The demographics for this study are very typical of a contemporary refractive surgery trial performed in the US. Gender of subjects treated was almost equally split with 51.0% (148/290) of the cases being female and 49.0% (142/290) being male. Overall, 91.4% (265/290) of eyes treated were in Caucasian subjects, 7.2% (21/290) in Hispanics, and 1.4% (4/290) were categorized as “other” races. The mean age of the patients treated was 51.6 +/- 8.8 years, with a range from 25 to 69.

Results Of The Study:

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