Kremer Laser FDA Test Results: Summary

Kremer Excimer Laser: FDA Test Results

Device Trade Name: Kremer Excimer Laser
Applicant: Photomed Inc., (Frederic B. Kremer, MD) King Of Prussia, PA., USA.
Approved By The FDA: February 13, 1998

The Kremer Excimer Laser, using a 6.0mm ablation zone, is indicated for myopic and astigmatic laser assisted in-situr keratomileusis (LASIK) in patients:

*With myopia ranging between -1.0 and -15.0 D with or without astigmatism ranging from 0.0 D to 5.00 D;

*Who are 18 years of age or older;

*With stable refraction over the 1 year period prior to surgery.

Summary Of Clinical Studies:
The sponsor performed a two cohort (group), single clinic study of the Kremer Excimer Laser System at the Kremer Laser Eye Center in the United States. A total of 2,482 eyes were treated under both groups, beginning May 1, 1993. The group 2 study was conducted under a slightly different FDA approved protocol. The database was closed for purposes of this analysis on November 20, 1997.
A. Study Objective
The objectives of this clinical investigation of the LASER-K Lasik procedure using the Kremer Excimer Laser were to reduce myopia and myopic astigmatism predictably and safely in eyes with myopia ranging between -1.0 D and -15.0 D, with or without astigmatism up to 5.0 D; Improve uncorrected visual acuity to reduce patients' dependence on spectacles and/or contact lenses.
B. Study Design
This was a prospective, non-randomized, unmasked, single-center clinical study performed by two surgeons, with the participant acting as their own controls.

The Kremer Excimer Laser was originally developed for the use of Dr. Kremer for his patients. It was developed to perform what has come to be referred to as the Laser K Lasik procedure. This device was first used for the LASIK treatment of patients in 1993 and until 1996 under studies approved by an Investigative Review Board (IRB).

Adverse Events/ Complications	Operative:	1 Month:	3 Months:	6 Months:	12 Months:
Corneal Infiltrate	N/A	0%	0%	0%	0%
Corneal Edema > 1 Mo	N/A	0.2%	0.1%	0%	0%
Flap Misalignment	N/A	0.1%	0%	0%	0%
Retinal Detachment	N/A	0%	0%	0%	0.3%
Corneal Edema < 1 Mo	3.4%	N/A	N/A	N/A	N/A
Incomplete Cap-Abort Procedure	0.3%	N/A	N/A	N/A	N/A
No Hinge On Flap	0.7%	N/A	N/A	N/A	N/A
Epithelial Defect-Central	N/A	0.1%	0.1%	0%	0%
Epithelial Defect-Peripheral	N/A	0.1%	0%	0.2%	0%
Epithelium In Interface-Central	N/A	0.1%	0%	0.2%	0%
Epithelium In Interface-Peripheral	N/A	0.9%	1.2%	1.2%	0.3%
Interface Foreign Bodies	N/A	14%	14%	15%	9%
Cap Striae	N/A	1.0%	0.7%	0.8%	0.3%
Pain	N/A	0.5%	0.5%	0.5%	0.7%
Glare	N/A	N/A	N/A	0.8%	1.8%
Halos	N/A	N/A	N/A	1%	0%
Night Driving Problems	N/A	N/A	N/A	1%	0.7%
Double Vision/Ghosts	N/A	N/A	N/A	1.5%	0.7%
Foreign Body Sensation	N/A	N/A	N/A	0.8%	0%
Anxiety	N/A	N/A	N/A	0%	0%

Retreatment:
Under Group 2, 47 eyes were retreated for undercorrection, for an overall enhancement rate of 3.5% (47/1342).

Patient Satisfaction:
No patient satisfaction survey was included in the study report.

Conclusions Drawn From The Clinical Study And Applicant Followup:
The laboratory and clinical results based on 665 eyes treated and followed for six months provide reasonable assurance that the Kremer Excimer Laser is safe and effective for LASIK procedures when used as indicated and in accordance with the directions for use. The Kremer Excimer Laser was approved by the FDA on February 13, 1998.

Demographics:
The demographics for both groups were quite similar. Slightly fewer females than males were treated, and the mean age was in the upper 30's for both groups. Slightly more eyes for myopic astigmatism were treated than for myopia only.

Results Of The Study:
In the table below are the reported adverse events and complications experienced by the patients in group 2:

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