Added: August 6, 1999
QUESTION #15: Can you provide more data to support the answer in FAQ # 5, that published peer reviewed studies support the contention that regression for excimer laser treatment of hyperopia is similar to the Sunrise LTK?
ANSWER #15: Our data show changes in refraction of the following magnitude:
SUNRISE LTK
Rate of Change Spherical Equivalent
At all time periods, change is less than 0.1 D per month
Interval Study Drift Rate Per Month
3 - 6 Months 0.09 D/Month
6 - 12 Months 0.06 D/Month
12 - 18 Months 0.04 D/Month
18 - 24 Months 0.02 D/Month
Excimer laser changes in refraction of the following magnitude are:
Refractive Drift Following Excimer Laser
Treatment of Hyperopia 1
Last Interval Drift Rate
Author Laser Treatment Studied Per Month
Ditzen Meditec LASIK 1 to 12 Months 0.06 D
Pietila Meditec PRK 1 to 12 Months 0.09 D
Daya Chiron PRK 3 to 6 Months 0.12 D
O'Brart Summit PRK 3 to 6 Months 0.14 D
Brancato Summit PRK 3 to 6 Months 0.36 D
Ibriham Nidek LASIK 6 to 9 Months 0.08 D
Vinciguerra Nidek PRK 6 to 12 Months 0.06 D
Dausch Meditec PRK 6 to 12 Months 0.03 D
Jackson Visx PRK 18 to 24 Months 0.03 D
SOME ADDITIONAL THOUGHTS:
We are disappointed by this setback caused by the Panel vote. However, we continue to believe that the safety and efficacy of the Sunrise LTK System meets or exceeds FDA guidances. We will be working with the FDA to resolve those concerns.
In the meantime, we will continue to be accessible to those who want to know about our Company. We urge you to continue to check this website for any additional questions and answers that may come up in the coming days and weeks.
I hope these questions and answers have shed some light on where we think the Company is today and what we plan to do in the near future.
Sincerely,
C. Russell Trenary III
President/Chief Executive Officer
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1
Hyperopic PRK Complications: Literature Review
R. Brancato, F. Carones, A. Morico, E. Venturi, L. Vigo, A. Spinelli, G. Gobbi, Hyperopia Correction Using an Erodible Mask Excimer Laser Delivery System Coupled to an Axicon: Preliminary Results. European Journal of Ophthalmology. Vol. 7, no.3, 1997: pp 203-210.
D. Dausch, Z. Smecka, R. Kleinm, E. Schroder, S. Kirchner. Excimer Laser Photorefractive Keratectomy for Hyperopia. Journal of Cataract & Refractive Surgery, Vol. 23, March 1997: pp 169-176.
S. Daya, F. Tappouni, N. Habib. Photorefractive Keratectomy for Hyperopia; Six Months Results in 45 Eyes. Ophthalmology, Vol. 104, no. 11, November 1997: pp 1952-1958.
W. B. Jackson, G. Mintsioulis, P. Agapitos, E. Casson. Excimer Laser Photorefractive Keratectomy for Low Hyperopia: Safety and Efficacy. Journal of Cataract & Refractive Surgery, Vol. 23, May 1997: pp 480-487.
D. O'Brart, C. Stephenson, K. Oliver, J. Marshall. Excimer Laser Photorefractive Keractectomy for the Correction of Hyperopia Using an Erodible Mask and Axicon System. Ophthalmology, Vol 104, no. 11, November 1997: pp 1959-1970.
J. Pietila, P. Makinen, S. Pajari, H. Uusitalo. Excimer Laser Photorefractive Keratectomy for Hyperopia. Journal of Refractive Surgery, Vol. 13, Sept/Oct 1997: pp 504-510.
B. Sener, A. Ozdamar, C. Aras, A. Yanyali. Photorefractive Keratectomy for Hyperopia and Aphakia with a Scanning Spot Excimer Laser. Journal of Refractive Surgery, Vol. 13, Nov/Dec 1997: pp 620-623.
Hyperopia LASIK Complications: Literature Review
K. Ditzen, H. Huschka, S. Pieger. Laser In Situ Keratomileusis for Hyperopia. Journal of Cataract & Refractive Surgery, Vol. 24, January 1998: pp 42-47.
W. B. Jackson, E. J. Casson, G. Mintsioulis, P.J. Agapitos, M.D., Lafontaine, W. G. Hodge; Correction of Hyperopia Using the Visx Star Excimer Laser. Invest Ophth Vis Sci, 391;S572, Abs 3465, 1998.
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