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 1

Jr De Juan E., Neil M Bressler, Susan B Bressler, Peter A Campochiaro, J. A. Haller, A. P. Schachat, J. Belt, T. Cain, M. Hartnett, P. Hawse, M. Herring, J. Imach, J. McDonald, T. Porter, M. A. Thomas, N. M. Holekamp, T. A. Meredith, B. Barts, L. Breeding, J. DahlJ. L. Gualdoni, G. Hoffmeyer, V. Nobel, E. Ort, Jr Sternberg P., Jr Capone A., J. I. Lim, J. M. Brown, D. K. Gibbs, J. Gilman, J. Johnson, R. Swords, R. G. Waldron, G. A. Williams, B. R. Garretson, K. L. Cumming, T. Medina, B. Mitchell, V. Regan, P. Streasick, L. D. Szydlowski, M. Zajechowski, C. A. Toth, G. J. Jaffe, M. M. Anderson, T. J. Hawks, R. Heinis, R. Schirmer, L. J. Singerman, T. A. Rice, S. D. Pendergast, J. DuBois, M. A. Ilc, D. Knight, S. E. Lichterman, K. A. Tilocco, R. L. Bergren, A. Campbell, K. Sedory, D. Steinberg, G. Vagstad, L. Wellman, L. Wilcox, H. Lewis, J. Conway, L. J. Holody, P. J. Vargo, R. McDonald, R. N. Johnson, M. DiAngelo, I. Rozenfeld, J. Uy, S. Wild, P. Wood, M. Lambert, P. Miller, J. Shigley, A. J. Brucker, J. Dupont, J. Lurcott, L. Weeney, W. J. Wood, L. C. McDowell, M. Oldroyd, E. Slade, J. L. Wolfe, P. F. Lopez, T. Nichols, F. A. Walonker, W. R. Freeman, T. Clark, R. Ochabski, B. Ramirez, M. Wilson, M. E. Hammer, W. J. Malenfant, J. Rollins, J. Traynom, Barbara S Hawkins

Research output: Contribution to journalArticle

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. (C) 2000 by Elsevier Science Inc.

Original languageEnglish (US)
Pages (from-to)387-407
Number of pages21
JournalAmerican Journal of Ophthalmology
Volume130
Issue number4
DOIs
StatePublished - Oct 2000

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Choroidal Neovascularization
Light Coagulation
Macular Degeneration
Lasers
Arm
Visual Acuity
Therapeutics
Laser Therapy
Multicenter Studies
Reading
Outcome Assessment (Health Care)
Clinical Trials

ASJC Scopus subject areas

  • Ophthalmology

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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 1. / De Juan E., Jr; Bressler, Neil M; Bressler, Susan B; Campochiaro, Peter A; Haller, J. A.; Schachat, A. P.; Belt, J.; Cain, T.; Hartnett, M.; Hawse, P.; Herring, M.; Imach, J.; McDonald, J.; Porter, T.; Thomas, M. A.; Holekamp, N. M.; Meredith, T. A.; Barts, B.; Breeding, L.; Dahl, J.; Gualdoni, J. L.; Hoffmeyer, G.; Nobel, V.; Ort, E.; Sternberg P., Jr; Capone A., Jr; Lim, J. I.; Brown, J. M.; Gibbs, D. K.; Gilman, J.; Johnson, J.; Swords, R.; Waldron, R. G.; Williams, G. A.; Garretson, B. R.; Cumming, K. L.; Medina, T.; Mitchell, B.; Regan, V.; Streasick, P.; Szydlowski, L. D.; Zajechowski, M.; Toth, C. A.; Jaffe, G. J.; Anderson, M. M.; Hawks, T. J.; Heinis, R.; Schirmer, R.; Singerman, L. J.; Rice, T. A.; Pendergast, S. D.; DuBois, J.; Ilc, M. A.; Knight, D.; Lichterman, S. E.; Tilocco, K. A.; Bergren, R. L.; Campbell, A.; Sedory, K.; Steinberg, D.; Vagstad, G.; Wellman, L.; Wilcox, L.; Lewis, H.; Conway, J.; Holody, L. J.; Vargo, P. J.; McDonald, R.; Johnson, R. N.; DiAngelo, M.; Rozenfeld, I.; Uy, J.; Wild, S.; Wood, P.; Lambert, M.; Miller, P.; Shigley, J.; Brucker, A. J.; Dupont, J.; Lurcott, J.; Weeney, L.; Wood, W. J.; McDowell, L. C.; Oldroyd, M.; Slade, E.; Wolfe, J. L.; Lopez, P. F.; Nichols, T.; Walonker, F. A.; Freeman, W. R.; Clark, T.; Ochabski, R.; Ramirez, B.; Wilson, M.; Hammer, M. E.; Malenfant, W. J.; Rollins, J.; Traynom, J.; Hawkins, Barbara S.

In: American Journal of Ophthalmology, Vol. 130, No. 4, 10.2000, p. 387-407.

Research output: Contribution to journalArticle

De Juan E., J, Bressler, NM, Bressler, SB, Campochiaro, PA, Haller, JA, Schachat, AP, Belt, J, Cain, T, Hartnett, M, Hawse, P, Herring, M, Imach, J, McDonald, J, Porter, T, Thomas, MA, Holekamp, NM, Meredith, TA, Barts, B, Breeding, L, Dahl, J, Gualdoni, JL, Hoffmeyer, G, Nobel, V, Ort, E, Sternberg P., J, Capone A., J, Lim, JI, Brown, JM, Gibbs, DK, Gilman, J, Johnson, J, Swords, R, Waldron, RG, Williams, GA, Garretson, BR, Cumming, KL, Medina, T, Mitchell, B, Regan, V, Streasick, P, Szydlowski, LD, Zajechowski, M, Toth, CA, Jaffe, GJ, Anderson, MM, Hawks, TJ, Heinis, R, Schirmer, R, Singerman, LJ, Rice, TA, Pendergast, SD, DuBois, J, Ilc, MA, Knight, D, Lichterman, SE, Tilocco, KA, Bergren, RL, Campbell, A, Sedory, K, Steinberg, D, Vagstad, G, Wellman, L, Wilcox, L, Lewis, H, Conway, J, Holody, LJ, Vargo, PJ, McDonald, R, Johnson, RN, DiAngelo, M, Rozenfeld, I, Uy, J, Wild, S, Wood, P, Lambert, M, Miller, P, Shigley, J, Brucker, AJ, Dupont, J, Lurcott, J, Weeney, L, Wood, WJ, McDowell, LC, Oldroyd, M, Slade, E, Wolfe, JL, Lopez, PF, Nichols, T, Walonker, FA, Freeman, WR, Clark, T, Ochabski, R, Ramirez, B, Wilson, M, Hammer, ME, Malenfant, WJ, Rollins, J, Traynom, J & Hawkins, BS 2000, '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 1', American Journal of Ophthalmology, vol. 130, no. 4, pp. 387-407. https://doi.org/10.1016/S0002-9394(00)00729-7
De Juan E., Jr ; Bressler, Neil M ; Bressler, Susan B ; Campochiaro, Peter A ; Haller, J. A. ; Schachat, A. P. ; Belt, J. ; Cain, T. ; Hartnett, M. ; Hawse, P. ; Herring, M. ; Imach, J. ; McDonald, J. ; Porter, T. ; Thomas, M. A. ; Holekamp, N. M. ; Meredith, T. A. ; Barts, B. ; Breeding, L. ; Dahl, J. ; Gualdoni, J. L. ; Hoffmeyer, G. ; Nobel, V. ; Ort, E. ; Sternberg P., Jr ; Capone A., Jr ; Lim, J. I. ; Brown, J. M. ; Gibbs, D. K. ; Gilman, J. ; Johnson, J. ; Swords, R. ; Waldron, R. G. ; Williams, G. A. ; Garretson, B. R. ; Cumming, K. L. ; Medina, T. ; Mitchell, B. ; Regan, V. ; Streasick, P. ; Szydlowski, L. D. ; Zajechowski, M. ; Toth, C. A. ; Jaffe, G. J. ; Anderson, M. M. ; Hawks, T. J. ; Heinis, R. ; Schirmer, R. ; Singerman, L. J. ; Rice, T. A. ; Pendergast, S. D. ; DuBois, J. ; Ilc, M. A. ; Knight, D. ; Lichterman, S. E. ; Tilocco, K. A. ; Bergren, R. L. ; Campbell, A. ; Sedory, K. ; Steinberg, D. ; Vagstad, G. ; Wellman, L. ; Wilcox, L. ; Lewis, H. ; Conway, J. ; Holody, L. J. ; Vargo, P. J. ; McDonald, R. ; Johnson, R. N. ; DiAngelo, M. ; Rozenfeld, I. ; Uy, J. ; Wild, S. ; Wood, P. ; Lambert, M. ; Miller, P. ; Shigley, J. ; Brucker, A. J. ; Dupont, J. ; Lurcott, J. ; Weeney, L. ; Wood, W. J. ; McDowell, L. C. ; Oldroyd, M. ; Slade, E. ; Wolfe, J. L. ; Lopez, P. F. ; Nichols, T. ; Walonker, F. A. ; Freeman, W. R. ; Clark, T. ; Ochabski, R. ; Ramirez, B. ; Wilson, M. ; Hammer, M. E. ; Malenfant, W. J. ; Rollins, J. ; Traynom, J. ; Hawkins, Barbara S. / 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 1. In: American Journal of Ophthalmology. 2000 ; Vol. 130, No. 4. pp. 387-407.
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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. (C) 2000 by Elsevier Science Inc.",
author = "{De Juan E.}, Jr and Bressler, {Neil M} and Bressler, {Susan B} and Campochiaro, {Peter A} and Haller, {J. A.} and Schachat, {A. P.} and J. Belt and T. Cain and M. Hartnett and P. Hawse and M. Herring and J. Imach and J. McDonald and T. Porter and Thomas, {M. A.} and Holekamp, {N. M.} and Meredith, {T. A.} and B. Barts and L. Breeding and J. Dahl and Gualdoni, {J. L.} and G. Hoffmeyer and V. Nobel and E. Ort and {Sternberg P.}, Jr and {Capone A.}, Jr and Lim, {J. I.} and Brown, {J. M.} and Gibbs, {D. K.} and J. Gilman and J. Johnson and R. Swords and Waldron, {R. G.} and Williams, {G. A.} and Garretson, {B. R.} and Cumming, {K. L.} and T. Medina and B. Mitchell and V. Regan and P. Streasick and Szydlowski, {L. D.} and M. Zajechowski and Toth, {C. A.} and Jaffe, {G. J.} and Anderson, {M. M.} and Hawks, {T. J.} and R. Heinis and R. Schirmer and Singerman, {L. J.} and Rice, {T. A.} and Pendergast, {S. D.} and J. DuBois and Ilc, {M. A.} and D. Knight and Lichterman, {S. E.} and Tilocco, {K. A.} and Bergren, {R. L.} and A. Campbell and K. Sedory and D. Steinberg and G. Vagstad and L. Wellman and L. Wilcox and H. Lewis and J. Conway and Holody, {L. J.} and Vargo, {P. J.} and R. McDonald and Johnson, {R. N.} and M. DiAngelo and I. Rozenfeld and J. Uy and S. Wild and P. Wood and M. Lambert and P. Miller and J. Shigley and Brucker, {A. J.} and J. Dupont and J. Lurcott and L. Weeney and Wood, {W. J.} and McDowell, {L. C.} and M. Oldroyd and E. Slade and Wolfe, {J. L.} and Lopez, {P. F.} and T. Nichols and Walonker, {F. A.} and Freeman, {W. R.} and T. Clark and R. Ochabski and B. Ramirez and M. Wilson and Hammer, {M. E.} and Malenfant, {W. J.} and J. Rollins and J. Traynom and Hawkins, {Barbara S}",
year = "2000",
month = "10",
doi = "10.1016/S0002-9394(00)00729-7",
language = "English (US)",
volume = "130",
pages = "387--407",
journal = "American Journal of Ophthalmology",
issn = "0002-9394",
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TY - JOUR

T1 - Submacular surgery trials randomized pilot trial of laser photocoagulation versus surgery for recurrent choroidal neovascularization secondary to age-related macular degeneration

T2 - I. Ophthalmic outcomes. Submacular Surgery Trials Pilot Study report number 1

AU - De Juan E., Jr

AU - Bressler, Neil M

AU - Bressler, Susan B

AU - Campochiaro, Peter A

AU - Haller, J. A.

AU - Schachat, A. P.

AU - Belt, J.

AU - Cain, T.

AU - Hartnett, M.

AU - Hawse, P.

AU - Herring, M.

AU - Imach, J.

AU - McDonald, J.

AU - Porter, T.

AU - Thomas, M. A.

AU - Holekamp, N. M.

AU - Meredith, T. A.

AU - Barts, B.

AU - Breeding, L.

AU - Dahl, J.

AU - Gualdoni, J. L.

AU - Hoffmeyer, G.

AU - Nobel, V.

AU - Ort, E.

AU - Sternberg P., Jr

AU - Capone A., Jr

AU - Lim, J. I.

AU - Brown, J. M.

AU - Gibbs, D. K.

AU - Gilman, J.

AU - Johnson, J.

AU - Swords, R.

AU - Waldron, R. G.

AU - Williams, G. A.

AU - Garretson, B. R.

AU - Cumming, K. L.

AU - Medina, T.

AU - Mitchell, B.

AU - Regan, V.

AU - Streasick, P.

AU - Szydlowski, L. D.

AU - Zajechowski, M.

AU - Toth, C. A.

AU - Jaffe, G. J.

AU - Anderson, M. M.

AU - Hawks, T. J.

AU - Heinis, R.

AU - Schirmer, R.

AU - Singerman, L. J.

AU - Rice, T. A.

AU - Pendergast, S. D.

AU - DuBois, J.

AU - Ilc, M. A.

AU - Knight, D.

AU - Lichterman, S. E.

AU - Tilocco, K. A.

AU - Bergren, R. L.

AU - Campbell, A.

AU - Sedory, K.

AU - Steinberg, D.

AU - Vagstad, G.

AU - Wellman, L.

AU - Wilcox, L.

AU - Lewis, H.

AU - Conway, J.

AU - Holody, L. J.

AU - Vargo, P. J.

AU - McDonald, R.

AU - Johnson, R. N.

AU - DiAngelo, M.

AU - Rozenfeld, I.

AU - Uy, J.

AU - Wild, S.

AU - Wood, P.

AU - Lambert, M.

AU - Miller, P.

AU - Shigley, J.

AU - Brucker, A. J.

AU - Dupont, J.

AU - Lurcott, J.

AU - Weeney, L.

AU - Wood, W. J.

AU - McDowell, L. C.

AU - Oldroyd, M.

AU - Slade, E.

AU - Wolfe, J. L.

AU - Lopez, P. F.

AU - Nichols, T.

AU - Walonker, F. A.

AU - Freeman, W. R.

AU - Clark, T.

AU - Ochabski, R.

AU - Ramirez, B.

AU - Wilson, M.

AU - Hammer, M. E.

AU - Malenfant, W. J.

AU - Rollins, J.

AU - Traynom, J.

AU - Hawkins, Barbara S

PY - 2000/10

Y1 - 2000/10

N2 - 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. (C) 2000 by Elsevier Science Inc.

AB - 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. (C) 2000 by Elsevier Science Inc.

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