Original articles
Submacular 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

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Abstract

PURPOSE: To summarize findings from health-related quality-of-life interviews with patients who had recurrent subfoveal choroidal neovascularization secondary to age-related macular degeneration and participated in a randomized pilot trial (focal confluent laser photocoagulation versus submacular surgery) that may assist in planning future assessments of health-related quality of life in patients with age-related macular degeneration.

PATIENTS AND METHODS: Of 70 patients enrolled in the pilot trial, 54 were interviewed before random assignment to treatment and provided the data analyzed for this report. Patients were scheduled for follow-up interviews at 6, 12, and 24 months after enrollment. The 36-Item Short-Form Health Survey was used in all cases and was administered by an interviewer. The summary scales, Physical Component Summary and Mental Component Summary, were the focus of this analysis.

RESULTS: Median Physical Component Summary and Mental Component Summary score at baseline were 47 and 53, respectively. Distributions of scores at baseline and throughout the 2-year follow-up period were similar in the two treatment arms and consistent with those of a sample of the general US population of similar age. Distributions of both Physical Component Summary scores and Mental Component Summary scores for individual patient subgroups at baseline suggested sensitivity to some measures of baseline vision. During 2 years of follow-up interviews, median changes in Physical Component Summary scores were decreases of six points in the laser arm and three points in the surgery arm; in both treatment arms, median change in Mental Component Summary scores was an increase of 2 points. Two-year changes in visual acuity had no discernible effect on Physical Component Summary scores or Mental Component Summary scores; baseline scores were the strongest predictors of 2-year changes in Physical Component Summary and Mental Component Summary scores.

CONCLUSIONS: Overall, summary scores from the 36-Item Short-Form Health Survey and changes in scores over 2 years in this pilot trial were consistent with the ophthalmic outcome measures (reported elsewhere) that showed no important differences between the treatment arms. These health-related quality-of-life findings provided assurance that the similarity of ophthalmic outcomes in the two treatment arms did not mask changes potentially important to patients that were not captured as part of the clinical outcome data.

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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    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.

    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).

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