Sunrise Announces Clinical TrialExpansion for Presbyopia
October 19, 1998 07:06 AM
FREMONT, Calif.--(BW HealthWire)--Oct. 19, 1998--Sunrise Technologies International Inc. SNRS announced today it has received conditional approval to expand the number of patients to be treated for its monovision clinical trial for treatment of presbyopia.
Presbyopia reduces the ability to see up close and is a normal part of the aging process. This investigation is a substudy of the primary hyperopia study. Currently, the substudy for presbyopia allows for a maximum of 60 patients to be enrolled at five sites; 47 patients have been treated to date. This new expansion will allow an additional 20 patients to be enrolled, for a total of 80 cases treated at up to five sites.
C. Russell Trenary III, president & CEO, stated, "We are pleased that we will be able to expand our trials for this very common problem. Patients with presbyopia are very aggravated by their inability to easily focus on near objects. It appears the best candidates for our procedure are those who have good unaided distance vision, but need help with seeing near.
"This group of patients might best be categorized as 'emmetropic presbyopes' and, according to peer reviewed studies, approximately 20% of the over 40-year-old population is 'emmetropic.' This is in addition to our initial study group of hyperopes in the +.75 to +2.5 diopter group that comprises approximately 31% of those over the age of 40."
According to Daniel S. Durrie, M.D., from the Hunkeler Eye Institute in Kansas City, Mo., "Our goal with this procedure is to get the patient to read their watch, dial the telephone, read a menu and to be able to engage in the normal daily activities that require good near vision. This is in contrast to the hyperopia study we are involved in with Sunrise where we are treating distance vision."
Dr. Durrie added, "I really like this procedure because it is much easier to define what these patients want to achieve with their vision."
According to Jeannie Gifford Cecka, "Early data from the first phase of our presbyopia substudy is very encouraging. The goal is to increase patients ability to see well with their treated eye for tasks performed up close and still have satisfactory distance vision from their untreated eye. We will continue to follow these patients for six months and longer."
Founded in 1987, the company produces and markets high technology products revolutionizing treatment methods in eye care. The company develops Holmium laser-based systems which utilize a patented process for shrinking collagen developed by Dr. Bruce Sand (the "Sand Process") in correcting ophthalmic conditions. These systems(a) incorporate a non-contact simultaneous application of energy for correction of hyperopia (farsightedness), presbyopia (loss of focus due to natural aging) and overcorrection resulting from PRK and LASIK treatments for myopia. The system is currently in use in Europe and the Americas, and is in clinical trials in the United States.
Except for historical information, this news release contains certain forward-looking statements that involve risk and uncertainties which may cause actual results to differ materially from the statements made, including market potential, regulatory clearances, business growth and other risks listed from time to time in the company's Securities and Exchange Commission (SEC) filings. These forward-looking statements represent the company's judgment, as of the date of this release, and the company disclaims any intent or obligation to update these forward-looking statements.
Internet users can access Sunrise's World Wide Web site at sunrise-tech.com.
(a) Caution -- Investigational Device: Federal law restricts this device to investigational use in the U.S.and/or its suppliers. All rights reserved.
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