Ladar Vision Excimer Laser System: FDA Test Results
Device Trade Name: LADARVision Excimer Laser System.
Applicant: Autonomous Technologies, Orlando, Florida, USA.
Approved By The FDA: November 3, 1998
Applicant: Autonomous Technologies, Orlando, Florida, USA.
Approved By The FDA: November 3, 1998
As of the date of this study, the LADARVision Excimer Laser has been placed in Italy and the UK for commercial use. The device has not been withdrawn from marketing for any reason relating to the safety and effectiveness of the device.
The LADARVision Excimer Laser System is indicated for use:
*In PRK treatments for the reduction or elimination of mild to moderate myopia (near sightedness);
*In subjects with documented stability of refraction for the prior 12 months;
*In subjects who are 21 years of age or older.
*In PRK treatments for the reduction or elimination of mild to moderate myopia (near sightedness);
*In subjects with documented stability of refraction for the prior 12 months;
*In subjects who are 21 years of age or older.
Summary Of Clinical Studies:
The applicant has conducted both foreign and domestic clinical trials using the LADARVision Excimer Laser System. The results in the foreign studies demonstrated conformance to all FDA performance guidelines for laser refractive correction. These trials provided the basis for initiation of the U.S. clinical trials as summarized below.
A. Study Objective
The objective of the multi-center (6 sites in the USA), clinical investigation of the LADARVision Excimer Laser was to assess the ability of the product to safely improve uncorrected visual acuity and to predictably reduce refractive error in healthy eyes. Treatments were performed for the reduction or elimination of mild to moderate myopia. There were 467 eyes treated for spherical myopia, and 211 eyes treated for myopia with astigmatism, for a total of 678 eyes treated. The test was conducted from March 12, 1996 to May 30, 1997.
B. Study Design
This was a prospective, non-randomized, unmasked multi-center clinical study where the primary control was the preoperative state of the treated eye.
The applicant has conducted both foreign and domestic clinical trials using the LADARVision Excimer Laser System. The results in the foreign studies demonstrated conformance to all FDA performance guidelines for laser refractive correction. These trials provided the basis for initiation of the U.S. clinical trials as summarized below.
A. Study Objective
The objective of the multi-center (6 sites in the USA), clinical investigation of the LADARVision Excimer Laser was to assess the ability of the product to safely improve uncorrected visual acuity and to predictably reduce refractive error in healthy eyes. Treatments were performed for the reduction or elimination of mild to moderate myopia. There were 467 eyes treated for spherical myopia, and 211 eyes treated for myopia with astigmatism, for a total of 678 eyes treated. The test was conducted from March 12, 1996 to May 30, 1997.
B. Study Design
This was a prospective, non-randomized, unmasked multi-center clinical study where the primary control was the preoperative state of the treated eye.
| Spherical Myopia (467 Eyes Treated) |
Myopia With Astigmatism (211 Eyes Treated) |
|
| Corneal Infiltrates |
1.5% |
1.9% |
| IOP Increase Above 25 mmHg | 0.2% | 1.4% |
| Feeling Of Something In The Eye | 3% | 2.4% |
| Double/Ghost Images | 2.6% | 6.2% |
| Peripheral Epithelial Defect | 1.3% | 0.5% |
| Pain | 1.3% | 1.9% |
| Halos/Starbursts | 0.6% | 0.5% |
Other Problems Encountered:
Other findings that occurred at a rate of less than 0.3% included corneal ulcer, erosion, abrasion, scratchiness, corneal swelling, light sensitivity, iritis, and ocular hypertension. Other events that did not occur in this study that could occur following PRK include significant corneal haze and loss of best-corrected visual acuity.
Other findings that occurred at a rate of less than 0.3% included corneal ulcer, erosion, abrasion, scratchiness, corneal swelling, light sensitivity, iritis, and ocular hypertension. Other events that did not occur in this study that could occur following PRK include significant corneal haze and loss of best-corrected visual acuity.
Patient Satisfaction:
Subjects were asked to rate their conditions at 6 months, compared to before surgery. The percentage of patients that rated each condition as "significantly worse" than preoperative are listed below:
Subjects were asked to rate their conditions at 6 months, compared to before surgery. The percentage of patients that rated each condition as "significantly worse" than preoperative are listed below:
| Spherical Myopia (358 Eyes Reporting) |
Myopia With Astigmatism (187 Eyes Reporting) |
|
| Difficulty With Night Driving |
4.3% | 9.4% |
| Glare |
1.7% | 4.4% |
| Halos |
2.3% | 6.1% |
| Feeling Of Something In The Eye |
1.4% |
0% |
| Fluctuation Of Vision |
1.1% | 3.8% |
| Blurring Of Vision |
0.9% | 2.2% |
| Light Sensitivity |
0.9% | 0.5% |
| Headache |
0.3% | 0.5% |
| Double Vision |
0.3% | 0.5% |
| Pain |
0.3% | 0% |
| Excessive Tearing |
0.3% | 0% |
| Burning |
0.3% | 0% |
Responses to the patient satisfaction questionnaire at 6 months indicated that in the spherical myopia group, the quality of vision was improved in 93.5% of eyes and 88.6% were satisfied or extremely satisfied with the results. There was no need for distance correction in 95.2% of eyes. In the myopia with astigmatism group, the quality of vision was improved in 93.4% of eyes and 87.4% were satisfied or extremely satisfied with the results. Distance correction was not required in 93.4% of eyes postoperatively.
Conclusions Drawn From The Clinical Study And Applicant Followup:
The applicant satisfactorily addressed the FDA's concerns with the initial laser head, and the LADARVision Excimer Laser System was approved on November 3, 1998.
The applicant satisfactorily addressed the FDA's concerns with the initial laser head, and the LADARVision Excimer Laser System was approved on November 3, 1998.
Demographics:
The demographics for this study are very typical of a contemporary refractive surgery trial performed in the US. Of the 678 eyes treated, 41% were from male subjects and 59% from female subjects. Ages ranged from 19-72 years. Caucasians made up approximately 92% of the study population, Blacks 2.5%, and Asians 4%. All other races were classified under "other".
Results Of The Study:
Adverse events and complications that occurred in the clinical study are shown below:
The demographics for this study are very typical of a contemporary refractive surgery trial performed in the US. Of the 678 eyes treated, 41% were from male subjects and 59% from female subjects. Ages ranged from 19-72 years. Caucasians made up approximately 92% of the study population, Blacks 2.5%, and Asians 4%. All other races were classified under "other".
Results Of The Study:
Adverse events and complications that occurred in the clinical study are shown below:
More On Laser Eye Surgery:
Contact Lenses | Glaucoma | Just For Fun | Eyeglasses | Eye Doctor | Eye Care And Symptoms | Eye Anatomy | Online Eye Tests | Laser Eye Surgery | Laser Eye Surgery Directory: Canada | Laser Eye Surgery Directory: USA | Laser Eye Surgery Reviews | Submit A Review | Contact Us | Privacy Policy | Sitemap
Copyright 2006-2009 Vision Health