Original articlesSubmacular surgery trials randomized pilot trial of laser photocoagulation versus surgery for recurrent choroidal neovascularization secondary to age-related macular degeneration: ii. quality of life outcomes submacular surgery trials pilot study report number 2☆
Section snippets
Methods
The methods of the Submacular Surgery Trials Pilot Study were similar to those described in detail in the Submacular Surgery Trials Manual of Procedures.27 The design and methods of each Submacular Surgery Trials pilot trial, including the health-related quality-of-life interviews, were reviewed and approved by the local institutional review board of each participating center before patient enrollment was initiated at that center. Each patient gave written consent, using a consent form approved
Results
Of the 70 patients who enrolled in this pilot trial, 55 (79%) enrolled at one of the 11 clinical centers that participated in quality-of-life data collection and thus were eligible for an interview at baseline. Of those eligible, 54 (98%) were interviewed before enrollment; the remaining patient was interviewed before having the assigned treatment (surgery) but after enrollment and randomization. Except for two patients, one in each treatment arm, who died during the second year of follow-up,
Discussion
The treatment arm comparisons based on the structured SF-36 interviews are consistent with the ophthalmic findings reported elsewhere for this pilot trial.26 No appreciable differences in either health-related quality of life or ophthalmic outcomes were found between treatment arms. Physical Component Summary scores and Mental Component Summary scores for the pilot trial patients were similar to those of a sample of the general US population of women and men of similar age.28
Given the ages of
Acknowledgements
Submacular Surgery Trials Executive Committee responsible for editorial review of this report: Neil M. Bressler, MD, Chair; Eric B. Bass, MD, MPH; Susan B. Bressler, MD; Mary Frances Cotch, PhD; Hans E. Grossniklaus, MD; Julia A. Haller, MD; Barbara S. Hawkins, PhD; Jennifer L. Holton; Carol M. Mangione, MD, MSPH; Peggy R. Orr, MPH, COMT; Steven D. Schwartz, MD; Jack O. Sipperley, MD; Paul Sternberg, Jr, MD; Matthew A. Thomas, MD; George A. Williams, MD.
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Cited by (41)
Removal of choroidal neovascular membrane in a case of macular hole after anti-VEGF therapy for age-related macular degeneration
2018, American Journal of Ophthalmology Case ReportsCitation Excerpt :Furthermore, the base of the MH was partially covered by the edge of the CNV. Previous multicenter trials that compared submacular surgery and observation for AMD have reported finding no benefits for the surgery with regard to the visual prognosis.11,12 Therefore, surgical removal of CNV is no longer performed for AMD at the present time.
Assessment of patient-reported outcomes in retinal diseases: a systematic review
2017, Survey of OphthalmologyProgressive Visual Loss in Subfoveal Exudation in Age-related Macular Degeneration: A Meta-analysis Using Lineweaver-Burke Plots
2007, American Journal of OphthalmologyCitation Excerpt :Data for modeling of the natural progression of disease were obtained from the control, untreated eyes in the following studies: the Macular Photocoagulation Study,4 Treatment of Age-related Macular Degeneration With TAP Study,29 Pegaptanib for Neovascular Age-related Macular Degeneration Study,33 Submacular Surgery Trials,40 anecortave acetate trial30–32 and the 360 degree Macular Translocation Study (MT360; macular translocation with 360-degree retinectomy).41,42
Quality of life in patients with age-related macular degeneration: Impact of the condition and benefits of treatment
2005, Survey of OphthalmologyCitation Excerpt :Although it is apparent that visual acuity influences QOL, different measures (e.g., NEI-VFQ or Short Form-36) indicate different relationships between visual acuity and QOL (Reichel MB, Nestler A, Gäbler P et al: Quality of life in patients with occult choroidal neovascularisation [abstract]. Invest Ophthalmol Vis Sci 42:S448, 2001).1,4 Given the large number of scales for QOL, the challenge for researchers is to define a measure that will enable them to compare outcomes between different medical specialties.8
Quality of life after macular translocation with 360° peripheral retinectomy for age-related macular degeneration
2005, OphthalmologyCitation Excerpt :The Treatment of Age-Related Macular Degeneration with Photodynamic Therapy study included an assessment of patients' QOL in its protocol, but the QOL results from that study have yet to be published.24 Quality of life was assessed as part of the SST, initially using the SF-36 because the NEI VFQ-25 had not been developed.18 The SF-36 PCS and MCS of patients who received either focal confluent laser or submacular surgery for subfoveal choroidal neovascularization were compared at baseline and 2 years after treatment.
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Funding for the Submacular Surgery Trials Pilot Study was provided through awards R21 EY10823 and U10 EY 11547 from the National Eye Institute of the National Institutes of Health, Bethesda, Maryland, and by donations to the Submacular Surgery Trials Research Fund from Alcon, Ft. Worth, Texas; Altsheller-Durrell Foundation, Louisville, Kentucky; Baylor College, Department of Ophthalmology, Houston, Texas; Cleveland Clinic Foundation, Cleveland, Ohio; Duke Eye Center, Durham, North Carolina; Grieshaber and Company, Schaffhausen, Switzerland; Humana of Lexington, Lexington, Kentucky; Ohio State University, Department of Ophthalmology, Columbus, Ohio; Presbyterian-St. Luke’s Hospital, Chicago, Illinois; Research to Prevent Blindness, Inc., New York, New York; Retina Associates of Cleveland, Cleveland, Ohio; Retina Associates of Florida, Tampa, Florida; Retina-Vitreous Consultants, Pittsburgh, Pennsylvania; Richardson Family Trust, Pittsburgh, Pennsylvania; Scheie Age-Related Macular Degeneration Research Fund, Philadelphia, Pennsylvania; Synergetics, Inc., St. Charles, Missouri; University of Miami, Department of Ophthalmology, Miami, Florida; William Beaumont Hospital, Royal Oak, Michigan; and the Wilmer Ophthalmological Institute’s Clinical Trials and Biometry Research Fund, Macular Research Fund, and Vitreoretinal Gift Fund, Baltimore, Maryland.
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A listing of all Submacular Surgery Trials Pilot Study investigators and personnel who contributed to this pilot trial and preparation of this report appears at the end of Submacular Surgery Trials Pilot Study Report Number 1. The members of the Submacular Surgery Trials Patient Centered Outcomes Subcommittee and Writing Committee for this report are Eric B. Bass, MD, MPH (Patient Centered Outcomes Subcommittee Co-chair); Neil M. Bressler, MD (Submacular Surgery Trials Chair); Susan B. Bressler, MD (Submacular Surgery Trials Executive Committee Representative); Li Ming Dong, PhD (Statistician); Barbara S. Hawkins, PhD (Writing Team Chair); Carol M. Mangione, MD, MSPH (Patient Centered Outcomes Subcommittee Chair); Marta J. Marsh, MS (Statistician); Paivi H. Miskala, MSPH (Writing Team Co-chair); Steven D. Schwartz, MD (Submacular Surgery Trials Executive Committee Representative).