LaserScan LSX: FDA Test Results
Device Trade Name: LaserScan LSX
Applicant: LaserSight Technologies Inc, Winter Park, Florida, USA.
Approved By The FDA: November 12, 1999
Applicant: LaserSight Technologies Inc, Winter Park, Florida, USA.
Approved By The FDA: November 12, 1999
The LaserSight Excimer Laser System Model Compak 200 was introduced into international markets in April 1993. The LaserScan 2000 model was introduced in 1995, and an upgraded version of the Compak 200, Model LS-300, was sold internationally beginning in 1996. The LaserScan LSX model was introduced in February 1998. Currently there are over 240 LaserSight excimer laser systems located in 31 countries around the world. The LaserSight excimer laser system has not been withdrawn from any country or market for reasons of safety or effectiveness.
The LaserScan LSX Excimer Laser System is indicated for myopic photorefractive keratectomy (PRK):
*For the reduction or elimination of myopia ranging from -1.0 to less than -6.0 diopters with less than or equal to 1.00 diopters of astigmatism;
*In subjects with documented stability of refraction for the prior 1 year;
*In subjects who are 18 years of age or older.
*For the reduction or elimination of myopia ranging from -1.0 to less than -6.0 diopters with less than or equal to 1.00 diopters of astigmatism;
*In subjects with documented stability of refraction for the prior 1 year;
*In subjects who are 18 years of age or older.
Summary Of Clinical Studies:
Three phases of study were conducted by the applicant. The first involved 10 blinded eyes and were conducted to determine the safety of the Compak 200 Mini-Excimer Laser; these results are not included in this summary.
A. Study Objective
The objectives of the Phase 2 and 3 studies were to determine the safety and effectiveness of the Compak 200/LaserScan 2000 Excimer Laser when used to perform PRK treatment of myopia in healthy eyes, and to assess stability of the achieved visual outcome.
Three phases of study were conducted by the applicant. The first involved 10 blinded eyes and were conducted to determine the safety of the Compak 200 Mini-Excimer Laser; these results are not included in this summary.
A. Study Objective
The objectives of the Phase 2 and 3 studies were to determine the safety and effectiveness of the Compak 200/LaserScan 2000 Excimer Laser when used to perform PRK treatment of myopia in healthy eyes, and to assess stability of the achieved visual outcome.
| <1 Month | 1 Month | 3 Months | 6 Months | 12 Months | |
| Corneal Infiltrates/ Ulcer < 1 Mo | N/A |
0.6% |
0% |
0% |
0% |
| Corneal Edema > 1 Mo | N/A |
0% |
0% |
0.4% |
0% |
| Persistent Central Epithelial Defect | N/A |
0.3% |
0% |
0% |
0% |
| Corneal Edema < 1 Mo | 0% |
N/A |
N/A |
N/A |
N/A |
| Corneal Infiltrate/ Ulcer < 1 Mo | 1.3% |
N/A |
N/A |
N/A |
N/A |
| Late Onset Of Haze >6 Mo With Loss Of > 2 Lines | N/A |
N/A |
N/A |
0% |
0.6% |
| Loss >2 Lines Beyond 6 Months | N/A |
N/A |
N/A |
0% |
0.6% |
| Recurrent Corneal Erosion |
N/A |
0% |
0.3% |
0% |
0.6% |
| Foreign Body Sensation | N/A |
0% |
0% |
1.5% |
0% |
| Pain/ Discomfort | N/A |
0% |
0.3% |
0.7% |
1.2% |
| Corneal Haze (Moderate to Marked) | N/A |
1.2% |
0.6% |
0% |
1.2% |
| Overcorrection >1 D | N/A |
N/A |
N/A |
7.3% |
4.9% |
| Overcorrection > 2 D | N/A |
N/A |
N/A |
1.1% |
0.6% |
Patient Satisfaction:
Patient events were recorded on a self-administered questionnaire preoperatively and at 3 or 6 months post treatment. Patients were asked to subjectively rate the presence or absence of the events noted at right. The most frequent findings were halos, double vision, clarity changes over time, and night vision problems.
Patient events were recorded on a self-administered questionnaire preoperatively and at 3 or 6 months post treatment. Patients were asked to subjectively rate the presence or absence of the events noted at right. The most frequent findings were halos, double vision, clarity changes over time, and night vision problems.
| Subjective Patient Adverse Events | Preop |
6 Months |
| Burning, Gritty Feeling | 3.6% |
8.2% |
| Halos, Starbursts | 13.7% |
23.4% |
| Watery Eyes | 3.0% |
3.3% |
| Double Vision/ Ghosts | 0.6% |
3.2% |
| Clarity Changes Day To Day | 3.0% |
12.1% |
| Night Vision Problems | 23.8% |
24.9% |
| Problems With Colors | 2.7% |
1.7% |
Conclusions Drawn From The Clinical Study:
The non-clinical and clinical results provide reasonable assurance that the LaserSight LaserScan LSX Excimer Laser System is safe and effective for the reduction or elimination of myopia ranging from -1.0 to < -6.0 D. The FDA issued its approval for the device on November 12, 1999.
The non-clinical and clinical results provide reasonable assurance that the LaserSight LaserScan LSX Excimer Laser System is safe and effective for the reduction or elimination of myopia ranging from -1.0 to < -6.0 D. The FDA issued its approval for the device on November 12, 1999.
B. Study Design
This was a prospective, non-randomized, multi-center study with the subjects acting as their own controls. A total of 564 eyes were treated in 360 patients.
Demographics:
The demographics for this study are very typical of a contemporary refractive surgery trial performed in the US. Of the 360 patients treated, 164 were male and 196 female. The mean age was 37.1 years and the ages ranged from 18 to 67. The majority of eyes treated had moderate myopia from -2.0 D to -8.0 D spherical equivalent with astigmatism under 1.0 D.
This was a prospective, non-randomized, multi-center study with the subjects acting as their own controls. A total of 564 eyes were treated in 360 patients.
Demographics:
The demographics for this study are very typical of a contemporary refractive surgery trial performed in the US. Of the 360 patients treated, 164 were male and 196 female. The mean age was 37.1 years and the ages ranged from 18 to 67. The majority of eyes treated had moderate myopia from -2.0 D to -8.0 D spherical equivalent with astigmatism under 1.0 D.
Results Of The Study:
Adverse events and complications that occurred in the clinical study are shown below:
Adverse events and complications that occurred in the clinical study are shown below:
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