the GLT found after two years of study that argon laser therapy appears to be a safe and effective alternative to eye drops for newly diagnosed open-angle glaucoma patients. Although these early findings are promising, GLT clinicians will follow patients for an additional three years to better determine the treatment's long-term safety and efficacy. This extended follow-up period is necessary because glaucoma is a chronic disease with a variable rate of progression. As NEI support of the GLT suggests, glaucoma continues to be an important area of NEI research interest. Two NEI-funded epidemiology studies, the Barbados Eye Study and the Baltimore Eye Survey are providing reliable new data on the prevalence of this potentially blinding disease. For example, Baltimore Eye Survey findings show that primary open-angle glaucoma is sixtimes more prevalent in Blacks over age 40 than in Whites. Because glaucoma is an age-related eye disease, these findings emphasize how important it is that middle-aged Black people need to have a comprehensive, dilated eye examination for glaucoma to reduce their risk of visual loss from this disease. One means that the NEI will utilize to encourage this practice is the National Eye Health Education Program (NEHEP), a public education effort mandated by the Congress. After close consultation and interaction with numerous voluntary and professional organizations, the NEHEP will this year launch a multi-media campaign targeted to Blacks over age 40 and all people over age 60 emphasizing the necessity of periodic glaucoma testing. NEHEP program will be targeted to the nation's more than 14 million people with diabetes who are at risk of developing diabetic eye disease, a leading cause of adult blindness. Another The NEI will also continue its efforts to help treat the devastating eye complications of AIDS. Specifically, cytomegalovirus (CMV) retinitis is the most common cause of severe vision loss among AIDS patients, affecting an estimated 25 percent of all victims of this disease. Unfortunately, this problem can be difficult to treat because both current drugs of choice, ganciclovir and foscarnet, can have toxic side effects, and at best can only control, not cure, the disease. To learn more about the comparative safety and efficacy of these drugs in AIDS patients, the NEI has begun the CMV Retinitis Trial. This clinical trial will evaluate the toxicity of ganciclovir and foscarnet, as well as monitor these drugs' effects on patient health and survival. The CMV Retinitis Trial is the first study conducted under a collaborative clinical research project called Studies of the Ocular Complications of AIDS (SOCA). SOCA has been designed so that as promising new therapies for AIDS-related eye diseases become available, they can be rapidly tested in a scientifically rigorous manner. Before concluding, I would like to reiterate the great social benefit of vision research. aspects of their daily lives, Institute-supported studies will continue to have a great impact in helping all Americans, young and old, maintain a high quality of life. As always, I look forward to keeping this Committee informed of the great progress that future vision research will certainly bring to the American public. Mr. Chairman, the FY 1992 budget request for the National Eye Institute is $272,260,000. I will be glad to answer any questions that the Committee might have. BIOGRAPHICAL SKETCH OF DR. CARL KUPFER Director, National Eye Institute February 9, 1928. New York, New York. Education: A.B., Yale Univ., 1945-48. M.D., The Johns Hopkins Medical Professional History: Internship and Assistant Residency, Wilmer Eye Inst., Professional Organizations: Amer. Physiological Society; Assoc. for Research in Vision and Ophthalmology; American Academy of Ophthalmology; American Ophthalmological Society; Pan American Ophthalmological Society; Johns Hopkins Univ. Soc. of Scholars; Member, Inst. of Medicine, Nat'l Academy of Sciences. Honors and Awards: The Secretary's Special Citation, Dept. of Health, Education and Welfare (DHEW), 1972; The Superior Service Award, DHEW, 1974; Presidential Rank Award of Meritorious Exec., 1983; Migel Medal, Amer. Foundation for the Blind, 1976; Public Service Award in Ophthalmology, Amer. Acad. of Ophthalmology and Otolaryngology, 1977; Special Award of Honor, The Assoc. for Research in Vision and Ophthalmology, 1983; David Rumbough Memorial Scientific Award, The Juvenile Diabetes Found., 1983; The Lighthouse Pisart Vision Award, 1984; Cavera Medal of Univ. of Rome, 1985; The Mildred Weisenfeld Award for Excellence in Ophthalmology, 1987. President's award for distinguished excellence in the Senior Executive Service, 1990. Invited Lecturer: Dunphy Lecture, 1977; Lorand V. Johnson Lecture, 1980; C. Other Scientific Activities: Editorial Bd, Investigative Ophthalmology, International Appointments: Mbr, Brd. of Trustees, Helen Keller Internat'l Inc., 1975-pres't; Coord. U.S.-Japan Collaborat. Agree'nt in Vision Research, 1976-pres't; Mbr, Internat'l Vitamin A Consultative Group, WHO, 1973-pres't; Mbr of U.S. Delegation to World Health Assembly, 1978; Mbr, WHO Advisory Group for Prevent. of Blindness Prog., 1978-84; Consultant, Pan Amer. Hlth Org., 1978-pres't; Coord. for USA, Priority Area "Eye Diseases," U.S. -U.S.S.R. Prog. for Health Cooperation, 1978-pres't; Mbr, WHO Expert Advis. Panel on Trachoma and Prevent. of Blindness, 1979-pres't; Dir., WHO Collabor. Ctr. for the Prevent. of Blindness, Nat'l Eye Inst., Bethesda, MD, 1979 -pres't; Pres., Internat'l Agency for the Prevent. of Blindness, Oct. 1982 -Nov. 1990. DETERIORATING VISION Senator HARKIN. I just learned something new that I will have to remember. The back part of the eye is part of the brain. Dr. KUPFER. Yes, sir; it is. Senator HARKIN. I'll have to think more about that. Tell me this. Why is this? When I was 30 years old and a fighter pilot in the Navy, I had 20/15 vision. I had great eyesight. And about age 43, 44, somewhere in there, all of a sudden there were things I couldn't read too well any longer. So, I had to get a pair of glasses, and they gave me these reading glasses. Then it got worse and worse. I am now 51. It seems like I went along and it took one drop and it sort of leveled off. Then it took another drop. Now it has leveled off, and I have to wear these now. Why is that? I can understand if you are born with an unhealthy eye or something, but when you have really healthy eyes and you have good eyesight, what happens? Why does it always happen around ageas I am told, around 45 to 50 years of age? Dr. KUPFER. That is correct. Your information is quite correct. The ability for us to look from a distance to near depends on changing the shape of the lens inside our eye. This ability to change the shape begins to decrease about the age of 40. So, that is why we need help from reading glasses or bifocal contact lenses, such as I and others wear to enable us to see what is close. Now research is being done on this condition, as you might imagine. It is very distressing, especially for those of us who have never worn glasses. Perhaps in the next 5 or 10 years we will have ways to correct this problem. Senator HARKIN. I can't wait. [Laughter.] How much more money do you need in your budget? [Laughter.] Dr. KUPFER. I think this will happen within our budget at the moment. GLAUCOMA TREATMENT Senator HARKIN. I wanted to ask one other question about glaucoma. Two typical treatments for glaucoma are medications, which reduce the pressure, and surgery to accomplish the same purpose. What can you tell us about the relative effect of these two approaches and quality of life considerations? Which is the better approach? Or is there one that is better than the other, or does it depend upon the situation? Dr. KUPFER. That is an excellent question. The situation with glaucoma is that it is completely asymptomatic. This is the openangle glaucoma which is the most common. Therefore, the individual can lose visual function without really being aware of any signs or symptoms until very late. When the diagnosis is made, we ask the patient to take drops. These drops themselves sometimes have adverse effects, plus the fact that it is very difficult to remember to take drops once, twice, or three times a day. On the other hand, to lower pressure, another possibility would be to perform a surgical intervention which creates a new path for the fluid to leave the eye. We do not know which is the better intervention. As a matter of fact, we are considering supporting a clinical trial which will randomly assign individuals who are newly diagnosed as having glaucoma to either medical treatment or surgical treatment with one of the major outcomes being which offers a better quality of life. So, in a number of years-hopefully not more than 3 or 4-we will begin to have information on this very question. I might say that in the United Kingdom, surgery is now used as the primary intervention, whereas in the United States, we still prefer medical treatment as the primary intervention. This clinical trial will give us a very definitive answer. QUESTIONS SUBMITTED BY THE SUBCOMMITTEE Senator HARKIN. Good. I look forward to that. Dr. Kupfer, thank you. I have some additional questions which we will submit to you in writing. [The following questions were not asked at the hearing, but were submitted to the Department for response subsequent to the hearing:] QUESTIONS SUBMITTED BY THE SUBCOMMITTEE Question. GLAUCOMA TREATMENT Dr. Kupfer, two typical treatments for glaucoma are medications which reduce the pressure within the eye and surgery to accomplish the same purpose. What can you tell us about the relative effect of these two approaches and the quality of life considerations associated with these two strategies? Answer. In the United States, the standard approach to the treatment of glaucoma has been to prescribe medications that reduce the intraocular pressure. When medications fail, attempts are made to reduce the intraocular pressure using argon laser trabeculoplasty, followed, if necessary, by filtration surgery. Results from the NEI-supported Glaucoma Laser Trial suggest that argon laser therapy may be a safe and effective alternative to eye drops, as a first treatment for patients with newly diagnosed openangle glaucoma. Another NEI-supported clinical trial of patients with uncontrolled glaucoma has shown that the use of 5-fluorouracil with surgery is more effective in controlling intraocular pressure than filtration surgery alone. Patients using glaucoma medicines often report serious side effects, including eye irritations, poor vision, fatigue, confusion, loss of appetite, and weight loss. The ophthalmologist attempts to maintain the patient's visual function without causing side effects that might offset the benefits of treatment. No major glaucoma studies have been conducted that specifically measure quality of life as an outcome of treatment decisions. Investigators are currently planning a randomized, clinical trial to evaluate the relative effects of medications versus surgery in managing newly diagnosed glaucoma patients. be assessed in this planned clinical trial. GLAUCOMA DISPARITY Quality of life will Question. Dr. Kupfer, it has been known for a long time that the prevalence of glaucoma in the black population is 4 to 5 time more than in the white population in the U.S. What factors lead to this great disparity? Answer. Although we now have some new data on the magnitude of black/white population differences in the prevalence of glaucoma, we need better information on why these differences exist. Differences in glaucoma prevalence rates reported for whites and for different groups of blacks may be due to genetic influences, variable access to health care, or unknown factors. We know that the prevalence of glaucoma reported from studies of blacks living in the United States is less than that of blacks residing in St. Lucia and Barbados. Well-designed epidemiologic studies examining risk factors for the development of glaucoma are needed since few risk factors, other than family history and diabetes, have been identified. AGE RELATED CATARACT AND MACULAR DEGENERATION Question. Age related cataract and age related macular degeneration are the major causes of visual impairment and |