Nidek EC-5000 Excimer Laser: FDA Test Results
Device Trade Name: Nidek EC-5000 Excimer Laser System
Applicant: Nidek Technologies, Inc., Pasadena CA, USA.
Approved By The FDA: December 17, 1998
Applicant: Nidek Technologies, Inc., Pasadena CA, USA.
Approved By The FDA: December 17, 1998
As of the date of this report, the EC-5000 Excimer Laser System has been distributed worldwide in more than 50 countries including Germany, France, UK, South Africa, Brazil, Chile, Mexico, Canada, Australia, Taiwan and Japan. The EC-5000 Excimer Laser has not been withdrawn from marketing for any reason relating to the safety and effectiveness of the device.
The EC-5000 is indicated for photorefractive keratectomy (PRK) for the reduction or elimination of mild to moderate myopia in patients with the following three characteristics:
*In PRK treatments for the reduction or elimination of myopia in the low, moderate, or high ranges, uncomplicated by refractive astigmatism.
*Patients who are 21 years of age or older;
*Patients who have a stable history of pretreatment myopia in the 12 months preceding treatment.
*In PRK treatments for the reduction or elimination of myopia in the low, moderate, or high ranges, uncomplicated by refractive astigmatism.
*Patients who are 21 years of age or older;
*Patients who have a stable history of pretreatment myopia in the 12 months preceding treatment.
Summary Of Clinical Studies:
The sponsor performed a multi-clinic (8 sites) study of the EC-5000 Excimer Laser System in the United States. The data from this study served as the basis for the approval decision.
A. Study Objective
The overall reason for the EC-5000 Excimer Laser System procedure was defined by this treatment goal: to assess the safety and efficacy of the EC-5000 system for the spherical correction of myopia.
B. Study Design
Subjects were treated between December 1994 and April 1997. The study included 611 subjects, who had a primary eye or both eyes treated (940 total eyes consisting of 611 primary eyes and 329 secondary eyes) at 8 clinical centers.
The sponsor performed a multi-clinic (8 sites) study of the EC-5000 Excimer Laser System in the United States. The data from this study served as the basis for the approval decision.
A. Study Objective
The overall reason for the EC-5000 Excimer Laser System procedure was defined by this treatment goal: to assess the safety and efficacy of the EC-5000 system for the spherical correction of myopia.
B. Study Design
Subjects were treated between December 1994 and April 1997. The study included 611 subjects, who had a primary eye or both eyes treated (940 total eyes consisting of 611 primary eyes and 329 secondary eyes) at 8 clinical centers.
Complications: |
Immediate Post Op: |
1 Month: |
3 Months: |
6 Months: |
| Corneal Edema Between 1 Week And 1 Month After The Procedure: | 0.2% |
0.0% |
0.0% |
0.0% |
| Recurrent Corneal Erosion At 1 Month Or Later: | 0.0% |
0.0% |
0.0% |
0.0% |
| Foreign Body Sensation (Including Itching And Scratchiness): | 77.5% |
0.0% |
0.0% |
0.0% |
| Pain (Including Discomfort, Pressure, Etc): | 100% |
0.0% |
0.2% |
0.0% |
| Ghost Or Double Images In The Operative Eye: | 1.3% |
0.0% |
0.0% |
0.0% |
| Blurred/Cloudy Vision: | 9% |
0.2% |
0.0% |
0.0% |
| Tearing/Watery Eyes: |
11% |
0.0% |
0.0% |
0.0% |
Photophobia: |
9% |
0.0% |
0.0% |
0.0% |
| Dry Eye (Including Irritation And Redness): |
9% |
0.0% |
0.0% |
0.0% |
Patient Satisfaction:
No patient satisfaction survey was included in the study report.
No patient satisfaction survey was included in the study report.
Retreatment:
Retreatment or "enhancement" procedures with the EC-5000 Excimer Laser System were performed on 28 eyes. This reflects a retreatment or enhancement rate of 3% for the overall study. No cases of more than one retreatment to an eye were recorded.
Retreatment or "enhancement" procedures with the EC-5000 Excimer Laser System were performed on 28 eyes. This reflects a retreatment or enhancement rate of 3% for the overall study. No cases of more than one retreatment to an eye were recorded.
Over-Correction and Under-Correction:
Over-correction of more than +1.00 D at 6 months occurred in 8% of eyes. Under-correction of more than -1.00 D at 6 months occurred in 7% of eyes.
Over-correction of more than +1.00 D at 6 months occurred in 8% of eyes. Under-correction of more than -1.00 D at 6 months occurred in 7% of eyes.
Conclusions Drawn From The Clinical Study:
The data in this application support reasonable assurance of the safety and effectiveness of this device when used in accordance with the indications of use. The FDA issued its approval for the EC-5000 Excimer Laser System on December 17, 1998.
The data in this application support reasonable assurance of the safety and effectiveness of this device when used in accordance with the indications of use. The FDA issued its approval for the EC-5000 Excimer Laser System on December 17, 1998.
Demographics:
The demographics for this study are very typical of a contemporary refractive surgery trial performed in the US. Of the 611 subjects, 49.9% (305/611) were from male subjects and 49.6% (303/611) from female subjects.
Results Of The Study:
The demographics for this study are very typical of a contemporary refractive surgery trial performed in the US. Of the 611 subjects, 49.9% (305/611) were from male subjects and 49.6% (303/611) from female subjects.
Results Of The Study:
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