Keracor 116 Excimer Laser: FDA Test Results
Device Trade Name: Keracor 116 Excimer Laser System
Applicant: Bausch & Lomb Surgical, Inc., Claremont, CA, USA.
Approved By The FDA: Sept 28, 1999
Applicant: Bausch & Lomb Surgical, Inc., Claremont, CA, USA.
Approved By The FDA: Sept 28, 1999
The Keracor 116 excimer laser system is intended for myopic photorefractive keratectomy (PRK) in patients who meet the following criteria:
*In PRK treatments for the reduction or elimination of myopia between -1.50 to -7.00D of sphere and less than or equal to -4.5D of astigmatism;
*Patients who are 18 years of age or older;
*Documented evidence of a change in manifest refraction of less than or equal to 0.50 diopters for at least one year prior to the date of the pre-operative examination.
*In PRK treatments for the reduction or elimination of myopia between -1.50 to -7.00D of sphere and less than or equal to -4.5D of astigmatism;
*Patients who are 18 years of age or older;
*Documented evidence of a change in manifest refraction of less than or equal to 0.50 diopters for at least one year prior to the date of the pre-operative examination.
Over 220 Keracor 116 lasers have been installed in the following countries since 1992: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, China, Columbia, Czech Republic, Denmark, Ecuador, France, Germany, India, Iran, Israel, Italy, Japan, Phillipines, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Syria, Turkey, Turks and Caicos, United States, and Venezuela. The Keracor 116 has not been withdrawn from any country or market for any reasons related to safety and effectiveness.
Summary Of Clinical Studies:
The sponsor performed a multi-clinic (16 sites) study of the Keracor 116 Excimer Laser System in the United States.
A. Study Objective
Clinical tests of the Keracor 116 Excimer Laser System were conducted to evaluate the safety and effectiveness of the laser in the correction of low to moderate myopia, with accompanying refractive astigmatism, when used in the procedure known as photorefractive keratectomy (PRK)..
B. Study Design
The study for this submission was a prospective, non-randomized, multi-center clinical evaluation of 714 eyes, with patients treated between September 1993 and October 1995.
The sponsor performed a multi-clinic (16 sites) study of the Keracor 116 Excimer Laser System in the United States.
A. Study Objective
Clinical tests of the Keracor 116 Excimer Laser System were conducted to evaluate the safety and effectiveness of the laser in the correction of low to moderate myopia, with accompanying refractive astigmatism, when used in the procedure known as photorefractive keratectomy (PRK)..
B. Study Design
The study for this submission was a prospective, non-randomized, multi-center clinical evaluation of 714 eyes, with patients treated between September 1993 and October 1995.
| Blepharitis | 0.3% | IOP Increase |
1.1% |
| Blurry Vision |
0.7% |
Irititis |
4.1% |
| Conjunctivitis |
1.0% |
Light Sensitivity |
2.4% |
| Corneal Epithelial Defect |
0.4% |
Night Driving |
4.5% |
| Corneal Scarring |
1.1% |
Pain/Burning |
2.3% |
| Dry Eye |
1.0% |
Patient Discomfort |
3.2% |
| Foreign Body Sensation |
4.1% |
Recurrent Erosion |
0.4% |
| Ghosting |
2.1% |
Redness |
0.8% |
| Glare |
11.3% |
Tearing |
0.7% |
| Halos |
4.8% |
Undercorrection |
0.7% |
| Haze |
0.3% |
Headaches |
0.6% |
Complications At Any Post Operative Visit:
Patient Satisfaction:
No patient satisfaction survey was included in the study report.
No patient satisfaction survey was included in the study report.
Conclusions Drawn From The Clinical Study:
The data in this application support reasonable assurance of the safety and effectiveness of this device for the treatment of PRK with or without astigmatism. The FDA approved the Keracor 116 Excimer Laser on September 28, 1999.
The data in this application support reasonable assurance of the safety and effectiveness of this device for the treatment of PRK with or without astigmatism. The FDA approved the Keracor 116 Excimer Laser on September 28, 1999.
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 50.6% of the cases being female and 49.4% being male. Overall, 96.9% of eyes treated were in Caucasian subjects, 0.7% in Blacks, 1.4% in Asians, and 0.7% were categorized as “other” races. The mean age of the patients treated was 38 +/- 9.5 years, with a range from 18 to 67. (These figures are for patients treated for spherical myopia. The astigmatic myopia patient demographics are virtually identical).
Results Of The Study:
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 50.6% of the cases being female and 49.4% being male. Overall, 96.9% of eyes treated were in Caucasian subjects, 0.7% in Blacks, 1.4% in Asians, and 0.7% were categorized as “other” races. The mean age of the patients treated was 38 +/- 9.5 years, with a range from 18 to 67. (These figures are for patients treated for spherical myopia. The astigmatic myopia patient demographics are virtually identical).
Results Of The Study:
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