- Email: [email protected]
Argon Laser Photocoagulation for Macular Edema in Branch Vein Occlusion
AMERICAN JOURNAL OF OPHTHALMOLOGY0 FRANK
W.
NEWELL,
Publisher and
Editor-in-Chief
Tribune Tower, Suite 1415, 435 North Michigan Ave., Chicago, Illinois 60611 EDITORIAL BOARD Thomas M. Aaberg, Milwaukee Mathea R. Allansmith, Boston Douglas R. Anderson, Miami Ronald M. Bürde, St. Louis Fred Ederer, Bethesda Frederick T. Fraunfelder, Fortland Eugene Helveston, Indianapolis Frederick A. Jakobiec, New York Herbert E. Kaufman, New Orleans
Kenneth R. Kenyon; Boston Steven G. Kramer, San Francisco Irving H. Leopold, Irvine Robert Machemer, Durham A. Edward Maumenee, Baltimore Irene H. Maumenee, Baltimore Nancy M. Newman, San Francisco Edward W. D. Norton, Miami G. Richard O'Connor, San Francisco
Amall Patz, Baltimore Deborah Pavan-Langston, Boston Stephen J. Ryan, Los Angeles David Shoch, Chicago Bruce E. Spivey, San Francisco Bradley R. Straatsma, Los Angeles H. Stanley Thompson, Iowa City Gunter K. von Noorden, Houston George O. Waring, Athnta
Published monthly by the Ophthalmic Publishing Company Tribune Tower, Suite 1415, 435 North Michigan Avenue, Chicago, Illinois 60611 Directors: A. EDWARD MAUMENEE, President; DAVID SHOCH, Vice President; FRANK W. NEWELL, Secretary and Treasurer; EDWARD W. D. NORTON, BRUCE E. SPIVEY, BRADLEY R. STRAATSMA
ARGON LASER PHOTOCOAGULATION F O R MACULAR E D E M A IN BRANCH V E I N OCCLUSION
center randomized clinical trials in gen eral. The randomized clinical trial, as a sci entific methodology, has provided nu An understanding of macular edema merous benefits since the first multiand its treatment has perplexed ophthal center trials in ophthalmology were mologists for decades. In this issue of T H E initiated and supported by the National Eye Institute. Not only has the random JOURNAL, the Branch Vein Occlusion Study Group adds to our knowledge of ized clinical trial provided answers to the the management of this condition with management of proliferative diabetic rettheir careful design and completion of a inopathy, age-related macular degenera randomized clinical trial of laser photoco tion, and currently branch vein occlusion agulation. Their demonstration of the macular edema, but now young investiga benefit of laser treatment represents an tors trained in t h e technique through other milestone in the investigation of exposure to the Diabetic Retinopathy retinal vascular disease; the clear demon Study in the 1970s are developing further stration by a randomized clinical trial that trials of other disease entities using the macular edema will respond to laser same methodology. It is heartening to photocoagulation is important informa observe the fine and productive research tion to further our understanding of mac studies spawned by t h e Diabetic Reti ular edema resulting from retinal vascu nopathy Study. lar disease. All clinical trials depend on prior pilot Several aspects of this study are in studies from innovative investigators sug structive to our thinking, not only about gesting treatment modalities, based on macular edema, but also about multi- clinical experience or laboratory investi374
VOL. 98, NO. 3 gation; branch vein occlusion macular edema is no exception. Numerous past reports have pioneered our understand ing of the natural development and laser management, as presented by Archer, Blankenship, Clemett, Coscas, Gass, Gutman, Hayreh, Henkind, Joffe, Kelley, Kohner, Krill, L'Espérance, Michels, Newell, Okun, Schatz, Shilling, Wetzig, Wise, Zegarra, and others, suggesting the efficacy of laster treatment, but also showing a surprising degree of spontaneous improvement without treat ment. Consequently, it became clear that a randomized clinical trial was required to compare treated to untreated patients. We are all indebted to the investigators whose studies have formed the rationale for the clinical trial reported in this issue of T H E JOURNAL.
Randomized clinical trials are not easy to perform. The years of design and prep aration, the years of patient recruitment, the years of data analysis, the years of follow-up, and the years of not knowing whether an answer will be forthcoming, all strain the tolerance of even the best of our young clinicians during the peak time of their productivity. It is a task only for the most dedicated and persevering. In 1975, the Branch Vein Occlusion Study Group began its preparations as the first investigator-initiated, grantsupported and sponsored by the National Eye Institute, multi-center randomized clinical trial. Commendably unique to the Branch Vein Occlusion Study is its small size (five principal investigators)
EDITORIAL
375
with limited goals and consequent saving in manpower and expense. With meticu lous adherence to a concise design, they were able to maintain a thrice yearly follow-up on virtually all of their patients, some for up to seven years. This remark ably long follow-up (mean, 3.1 years) emphasizes the dedication that can be achieved by patient and physician alike when an appropriate esprit is established and maintained. The long follow-up also emphasizes the significance of the treat ment effect. In addition to the 139 cases reported in this study of macular edema, the Branch Vein Occlusion Study Group still main tains the arduous task of continuing to follow up 450 cases with the threat of neovascularization, vitreous hemorrhage, or both, with a Data and Safety Monitor ing Board regularly monitoring laser treatment efficacy. We look forward to learning the results of these other as pects. All investigators who have been willing to undertake the difficult task of partici pation in randomized clinical trials are to be congratulated; they have answered important questions of management in the most common of retinal diseases: dia betes, macular degeneration, and now branch vein occlusion. ARNALL PATZ
Reprint requests to Arnall Patz, M.D., 505 Maumenee Building, Wilmer Institute, Johns Hopkins University and Hospital, Baltimore, MD 21205.
W.
NEWELL,
Publisher and
Editor-in-Chief
Tribune Tower, Suite 1415, 435 North Michigan Ave., Chicago, Illinois 60611 EDITORIAL BOARD Thomas M. Aaberg, Milwaukee Mathea R. Allansmith, Boston Douglas R. Anderson, Miami Ronald M. Bürde, St. Louis Fred Ederer, Bethesda Frederick T. Fraunfelder, Fortland Eugene Helveston, Indianapolis Frederick A. Jakobiec, New York Herbert E. Kaufman, New Orleans
Kenneth R. Kenyon; Boston Steven G. Kramer, San Francisco Irving H. Leopold, Irvine Robert Machemer, Durham A. Edward Maumenee, Baltimore Irene H. Maumenee, Baltimore Nancy M. Newman, San Francisco Edward W. D. Norton, Miami G. Richard O'Connor, San Francisco
Amall Patz, Baltimore Deborah Pavan-Langston, Boston Stephen J. Ryan, Los Angeles David Shoch, Chicago Bruce E. Spivey, San Francisco Bradley R. Straatsma, Los Angeles H. Stanley Thompson, Iowa City Gunter K. von Noorden, Houston George O. Waring, Athnta
Published monthly by the Ophthalmic Publishing Company Tribune Tower, Suite 1415, 435 North Michigan Avenue, Chicago, Illinois 60611 Directors: A. EDWARD MAUMENEE, President; DAVID SHOCH, Vice President; FRANK W. NEWELL, Secretary and Treasurer; EDWARD W. D. NORTON, BRUCE E. SPIVEY, BRADLEY R. STRAATSMA
ARGON LASER PHOTOCOAGULATION F O R MACULAR E D E M A IN BRANCH V E I N OCCLUSION
center randomized clinical trials in gen eral. The randomized clinical trial, as a sci entific methodology, has provided nu An understanding of macular edema merous benefits since the first multiand its treatment has perplexed ophthal center trials in ophthalmology were mologists for decades. In this issue of T H E initiated and supported by the National Eye Institute. Not only has the random JOURNAL, the Branch Vein Occlusion Study Group adds to our knowledge of ized clinical trial provided answers to the the management of this condition with management of proliferative diabetic rettheir careful design and completion of a inopathy, age-related macular degenera randomized clinical trial of laser photoco tion, and currently branch vein occlusion agulation. Their demonstration of the macular edema, but now young investiga benefit of laser treatment represents an tors trained in t h e technique through other milestone in the investigation of exposure to the Diabetic Retinopathy retinal vascular disease; the clear demon Study in the 1970s are developing further stration by a randomized clinical trial that trials of other disease entities using the macular edema will respond to laser same methodology. It is heartening to photocoagulation is important informa observe the fine and productive research tion to further our understanding of mac studies spawned by t h e Diabetic Reti ular edema resulting from retinal vascu nopathy Study. lar disease. All clinical trials depend on prior pilot Several aspects of this study are in studies from innovative investigators sug structive to our thinking, not only about gesting treatment modalities, based on macular edema, but also about multi- clinical experience or laboratory investi374
VOL. 98, NO. 3 gation; branch vein occlusion macular edema is no exception. Numerous past reports have pioneered our understand ing of the natural development and laser management, as presented by Archer, Blankenship, Clemett, Coscas, Gass, Gutman, Hayreh, Henkind, Joffe, Kelley, Kohner, Krill, L'Espérance, Michels, Newell, Okun, Schatz, Shilling, Wetzig, Wise, Zegarra, and others, suggesting the efficacy of laster treatment, but also showing a surprising degree of spontaneous improvement without treat ment. Consequently, it became clear that a randomized clinical trial was required to compare treated to untreated patients. We are all indebted to the investigators whose studies have formed the rationale for the clinical trial reported in this issue of T H E JOURNAL.
Randomized clinical trials are not easy to perform. The years of design and prep aration, the years of patient recruitment, the years of data analysis, the years of follow-up, and the years of not knowing whether an answer will be forthcoming, all strain the tolerance of even the best of our young clinicians during the peak time of their productivity. It is a task only for the most dedicated and persevering. In 1975, the Branch Vein Occlusion Study Group began its preparations as the first investigator-initiated, grantsupported and sponsored by the National Eye Institute, multi-center randomized clinical trial. Commendably unique to the Branch Vein Occlusion Study is its small size (five principal investigators)
EDITORIAL
375
with limited goals and consequent saving in manpower and expense. With meticu lous adherence to a concise design, they were able to maintain a thrice yearly follow-up on virtually all of their patients, some for up to seven years. This remark ably long follow-up (mean, 3.1 years) emphasizes the dedication that can be achieved by patient and physician alike when an appropriate esprit is established and maintained. The long follow-up also emphasizes the significance of the treat ment effect. In addition to the 139 cases reported in this study of macular edema, the Branch Vein Occlusion Study Group still main tains the arduous task of continuing to follow up 450 cases with the threat of neovascularization, vitreous hemorrhage, or both, with a Data and Safety Monitor ing Board regularly monitoring laser treatment efficacy. We look forward to learning the results of these other as pects. All investigators who have been willing to undertake the difficult task of partici pation in randomized clinical trials are to be congratulated; they have answered important questions of management in the most common of retinal diseases: dia betes, macular degeneration, and now branch vein occlusion. ARNALL PATZ
Reprint requests to Arnall Patz, M.D., 505 Maumenee Building, Wilmer Institute, Johns Hopkins University and Hospital, Baltimore, MD 21205.