Original articles
Submacular surgery trials randomized pilot trial of laser photocoagulation versus surgery for recurrent choroidal neovascularization secondary to age-related macular degeneration: i. ophthalmic outcomes submacular surgery trials pilot study report number 12

Preliminary findings from this pilot trial were presented at the Vitreoretinal Specialty Meeting, American Academy of Ophthalmology, New Orleans, Nov 6, 1998, and at the Annual Meeting of the Macula Society, San Diego, Feb 26, 1999.
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Abstract

PURPOSE: To report complications and changes in vision during 2 years of follow-up of patients with age-related macular degeneration assigned randomly to surgical removal or to laser photocoagulation of subfoveal recurrent neovascular lesions in a pilot trial designed to test methods, to refine estimates of outcome rates, and to project patient accrual rates for a larger multicenter randomized trial to evaluate submacular surgery.

PATIENTS AND METHODS: Eligible patients with previous laser photocoagulation of extrafoveal or juxtafoveal choroidal neovascularization secondary to age-related macular degeneration were enrolled at 15 collaborating clinical centers. Assignments to treatment arm were made by personnel at a central coordinating center. Adherence to eligibility criteria and treatment assignment was assessed centrally at a photograph reading center. Patients were examined at 3, 6, 12, and 24 months after treatment for data collection purposes. Outcome measures reported include treatment complications, adverse events, requirements for additional treatment, and 2-year changes in visual acuity from baseline.

RESULTS: Of 70 patients enrolled, 36 were assigned to laser photocoagulation and 34 to submacular surgery; all were treated as assigned. One patient in each group died before the 2-year examination. Visual acuity was measured at the 2-year examination for 31 of the surviving patients (89%) in the laser arm and for 28 of the surviving patients (85%) in the surgery arm. The 2-year measurements for 36 of the 59 patients (61%) were made by an examiner masked to treatment assignment and to the identity of the study eye. Improvements and losses of visual acuity were observed in both treatment arms; 20 of 31 study eyes (65%) in the laser arm and 14 of 28 study eyes (50%) in the surgery arm had visual acuity 2 years after enrollment that was better than or no more than 1 line worse than the baseline level. Changes in visual acuity and the size of the central macular lesions from baseline to the 2-year examination were similar in the treatment arms. Few serious complications were observed in either arm at the time of initial treatment; serious adverse events were rare. During follow-up, 11 laser-treated eyes and 18 surgically treated eyes had additional intraocular procedures.

CONCLUSIONS: The data from this pilot trial suggest no reason to prefer submacular surgery over laser photocoagulation for treatment of patients with age-related macular degeneration who have lesions similar to those studied in this pilot trial. Any clinical trial designed to compare submacular surgery with laser photocoagulation in eyes with age-related macular degeneration and subfoveal recurrent neovascular lesions must enroll several hundred patients in order to reach a statistically valid conclusion regarding differences between these two methods of treatment with respect to either changes in visual acuity or complication rates.

Section snippets

Methods

The rationale, design, and methods of each Submacular Surgery Trials pilot trial 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 by the local institutional review board, before enrollment and random assignment to the surgery or laser photocoagulation arm. The methods of the Submacular Surgery Trials Pilot Study were similar to

Results

As of March 14, 1997, when accrual halted, a total of 70 patients had enrolled in the pilot trial of laser photocoagulation versus submacular surgery for subfoveal recurrent choroidal neovascularization with age-related macular degeneration. Investigators at 15 of the 18 clinical centers participating in the Submacular Surgery Trials Pilot Study enrolled patients in this trial; the number enrolled per center ranged from nine patients at two centers to a single patient at three centers. Based on

Discussion

The Submacular Surgery Trials pilot trial of treatment for subfoveal recurrent choroidal neovascularization secondary to age-related macular degeneration in which patients were assigned randomly to laser photocoagulation or to submacular surgery was designed to test methods and refine sample size estimates for a larger clinical trial and to assess the willingness of patients and their ophthalmologists to participate in such a randomized trial. The pilot trial was not designed to compare

Clinical personnel who contributed data to this pilot trial

The Wilmer Ophthalmological Institute, Baltimore, MD: Eugene de Juan, Jr, MD, Principal Investigator; Neil M. Bressler, MD; Susan B. Bressler, MD; Peter A. Campochiaro, MD; Julia A. Haller, MD; Andrew P. Schachat, MD; Judith Belt; Terri Cain; Mike Hartnett, COT; Patricia Hawse, COT; Mark Herring; Jennifer Imach; Jacquelyn McDonald; Tracey Porter, COT.

Barnes Retina Institute, St. Louis, MO: Matthew A. Thomas, MD, Principal Investigator; Nancy M. Holekamp, MD; Travis A. Meredith, MD; Bryan Barts;

References (25)

  • Krypton laser photocoagulation for neovascular lesions of age-related macular degeneration. Results of a randomized clinical trial

    Arch Ophthalmol

    (1990)

  • Laser photocoagulation for juxtafoveal choroidal neovascularization. Five-year results from randomized clinical trials

    Arch Ophthalmol

    (1994)

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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 this article. The members of the Writing Committee for this report are Neil M. Bressler, MD, Submacular Surgery Trials Chair; Susan B. Bressler, MD; Barbara S. Hawkins, PhD, Writing Committee Chair; Marta J. Marsh, MS, Writing Committee Statistician; Paul Sternberg, Jr, MD, Writing Committee Co-chair; Matthew A. Thomas, MD.

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