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December 1995, Vol 113, No. 12 >
ARTICLE | December 1995

Submacular Surgery: Title and subTitle BreakAre Randomized Trials Necessary? FREE

Neil M. Bressler, MD
Arch Ophthalmol. 1995;113(12):1557-1560. doi:10.1001/archopht.1995.01100120087016
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Prospective randomized clinical trials offer an outstanding means of evaluating the benefits and risks of a medical or surgical intervention. Results generated from various well-designed clinical trials in ophthalmology, such as the Diabetic Retinopathy Study1 and the Macular Photocoagulation Study,2 have provided ophthalmologists with evidence on which to base management decisions. A variety of other factors also influence a physician's decision to recommend a particular course of action, including personal experience, the experience of colleagues, epidemiologic study findings, case series reports, and data from retrospective studies. However, many of these additional resources may have inherent biases. The enforcement of strict eligibility criteria and the randomization process performed within the context of a prospective controlled clinical trial reduce such biases, or at least balance them equally between the treatment arms of the study, and thus provide us with a more accurate assessment of a particular therapy.

Despite the relative

REFERENCES

1 +
The Diabetic Retinopathy Study Research Group.  Photocoagulation treatment of proliferative diabetic retinopathy: clinical applications of Diabetic Retinopathy Study (DRS) findings: DRS Report Number 8 . Ophthalmology . 1981;;88:583-600.
2 +
Macular Photocoagulation Study Group.  Laser photocoagulation of subfoveal neovascular lesions of age-related macular degeneration: updated findings from two clinical trials . Arch Ophthalmol . 1993;;111:1200-1209.
3 +
Kini MM, Leibowitz HM, Colton T, et al.  Prevalence of senile cataract, diabetic retinopathy, senile macular degeneration, and open angle glaucoma in the Framingham Eye Study . Am J Ophthalmol . 1978;;85:28-34.
4 +
Sommer A, Tielsch JM, Katz J, et al.  Racial differences in the cause-specific prevalence of blindness in East Baltimore . N Engl J Med . 1991;;14:1412-1417.
5 +
Klein R, Wang Q, Klein BEK, Moss S, Meuer SM.  The relationship of age-related maculopathy, cataract, and glaucoma to visual acuity . Invest Ophthalmol Vis Sci . 1995;;36:182-191.
6 +
Bressler SB, Maguire MG, Bressler NM, et al.  Relationship of drusen and abnormalities of the retinal pigment epithelium to the prognosis of neovascular macular degeneration . Arch Ophthalmol . 1990;;108:1442-1447.
7 +
Macular Photocoagulation Study Group.  Argon laser photocoagulation for neovascular maculopathy: five-year results from randomized clinical trials . Arch Ophthalmol . 1991;;109:1109-1114.
8 +
Macular Photocoagulation Study Group.  Krypton laser photocoagulation for neovascular lesions of age-related macular degeneration: results of a randomized clinical trial . Arch Ophthalmol . 1990;;108:816-824.
9 +
Macular Photocoagulation Study Group.  Laser photocoagulation of subfoveal neovascular lesions in age-related macular degeneration: results of a randomized clinical trial . Arch Ophthalmol . 1991;;109:1220-1231.
10 +
Bressler NM, Bressler SB, Gragoudas EG.  Clinical characteristics of choroidal neovascular membranes . Arch Ophthalmol . 1987;;105:209-213.
11 +
Freund KB, Yannuzzi LA, Sorenson JA.  Age-related macular degeneration and choroidal neovascularization . Am J Ophthalmol . 1993;;115:786-791.
12 +
Macular Photocoagulation Study Group.  Visual outcome after laser photocoagulation for subfoveal choroidal neovascularization secondary to age-related macular degeneration: the influence of initial lesion size and initial visual acuity . Arch Ophthalmol . 1994;;112:480-488.
13 +
Gunby P.  Ocular histoplasmosis . JAMA . 1980;;243:626-627.
14 +
Macular Photocoagulation Study Group.  Argon laser photocoagulation for ocular histoplasmosis: results from a randomized clinical trial . Arch Ophthalmol . 1983;;101:1347-1357.
15 +
Macular Photocoagulation Study Group.  Krypton laser photocoagulation for neovascular lesions of ocular histoplasmosis: results of a clinical trial . Arch Ophthalmol . 1987;;105:1499-1507.
16 +
Macular Photocoagulation Study Group.  Recurrent choroidal neovascularization after argon laser treatment for neovascular maculopathy . Arch Ophthalmol . 1986;;104:503-512.
17 +
Macular Photocoagulation Study Group.  Persistent and recurrent neovascularization after krypton laser photocoagulation for neovascular lesions of ocular histoplasmosis . Arch Ophthalmol . 1989;;107:344-352.
18 +
Fine SL, Wood WJ, Isernhagen RD, et al.  Laser treatment for subfoveal neovascular membranes in ocular histoplasmosis syndrome: results of a pilot randomized clinical trial . Arch Ophthalmol . 1993;;111:19-20.
19 +
Thomas MS, Grand MG, Williams DF, et al.  Surgical management of subfoveal choroidal neovascularization . Ophthalmology . 1992;;99:952-966.
20 +
Berger AS, Kaplan HJ.  Clinical experience with the surgical removal of subfoveal neovascular membranes . Ophthalmology . 1992;;99:969-976.
21 +
Lambert HM, Capone A, Aaberg TM, et al.  Surgical excision of subfoveal neovascular membranes in age-related macular degeneration . Am J Ophthalmol . 1992;;114:241-242.
22 +
Macular Photocoagulation Study Group.  The influence of treatment extent on the visual acuity of eyes treated with krypton laser for juxtafoveal choroidal neovascularization . Arch Ophthalmol . 1995;;113:190-194.
23 +
Macular Photocoagulation Study Group.  Persistent and recurrent choroidal neovascularization after laser photocoagulation for subfoveal choroidal neovascularization of age-related macular degeneration . Arch Ophthalmol . 1994;;112:489-499.
24 +
Vander JF, Federman JL, Greven C, Slusher MM, Gabel VP.  Surgical removal of massive subretinal hemorrhage associated with age-related macular degeneration . Ophthalmology . 1991;;98:23-27.
25 +
Wade EC, Flynn HW, Olsen KR, Blumenkranz MS, Nicholson DH.  Subretinal hemorrhage management by pars plana vitrectomy and internal drainage . Arch Ophthalmol . 1990;;108:973-978.
26 +
Lewis H.  Management of submacular hemorrhage . In: Lewis H, Ryan SJ, eds. Medical and Surgical Retina . St Louis, Mo: Mosby-Year Book; 1994;:54-62.
27 +
 American Academy of Ophthalmology 1994 Annual Meeting Final Program Abstract Book . Ophthalmology . 1994;;101( (suppl) ):68, 69, 139.
28 +
 The Association for Research in Vision and Ophthalmology Annual Meeting Abstract Book . Invest Ophthalmol Vis Sci . 1994;;35( (ARVO suppl) ):1260, 1504, 1712-1714.
29 +
 The Association for Research in Vision and Ophthalmology Annual Meeting Abstract Book . Invest Ophthalmol Vis Sci . 1995;;36( (ARVO suppl) ):89, 211, 212, 252, 553, 656, 1070.
30 +
Ebert EM, Fine AM, Markowitz J, Maguire MG, Starr JS, Fine SL.  Functional vision in patients with neovascular maculopathy and poor visual acuity . Arch Ophthalmol . 1986;;104:1009-1012.
31 +
Bynoe LA, Chang TS, Funata M, Del Priore LV, Kaplan HJ, Green WR.  Histopathologic examination of vascular patterns in subfoveal neovascular membranes . Ophthalmology . 1994;;104:1112-1117.

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1 +
The Diabetic Retinopathy Study Research Group.  Photocoagulation treatment of proliferative diabetic retinopathy: clinical applications of Diabetic Retinopathy Study (DRS) findings: DRS Report Number 8 . Ophthalmology . 1981;;88:583-600.
2 +
Macular Photocoagulation Study Group.  Laser photocoagulation of subfoveal neovascular lesions of age-related macular degeneration: updated findings from two clinical trials . Arch Ophthalmol . 1993;;111:1200-1209.
3 +
Kini MM, Leibowitz HM, Colton T, et al.  Prevalence of senile cataract, diabetic retinopathy, senile macular degeneration, and open angle glaucoma in the Framingham Eye Study . Am J Ophthalmol . 1978;;85:28-34.
4 +
Sommer A, Tielsch JM, Katz J, et al.  Racial differences in the cause-specific prevalence of blindness in East Baltimore . N Engl J Med . 1991;;14:1412-1417.
5 +
Klein R, Wang Q, Klein BEK, Moss S, Meuer SM.  The relationship of age-related maculopathy, cataract, and glaucoma to visual acuity . Invest Ophthalmol Vis Sci . 1995;;36:182-191.
6 +
Bressler SB, Maguire MG, Bressler NM, et al.  Relationship of drusen and abnormalities of the retinal pigment epithelium to the prognosis of neovascular macular degeneration . Arch Ophthalmol . 1990;;108:1442-1447.
7 +
Macular Photocoagulation Study Group.  Argon laser photocoagulation for neovascular maculopathy: five-year results from randomized clinical trials . Arch Ophthalmol . 1991;;109:1109-1114.
8 +
Macular Photocoagulation Study Group.  Krypton laser photocoagulation for neovascular lesions of age-related macular degeneration: results of a randomized clinical trial . Arch Ophthalmol . 1990;;108:816-824.
9 +
Macular Photocoagulation Study Group.  Laser photocoagulation of subfoveal neovascular lesions in age-related macular degeneration: results of a randomized clinical trial . Arch Ophthalmol . 1991;;109:1220-1231.
10 +
Bressler NM, Bressler SB, Gragoudas EG.  Clinical characteristics of choroidal neovascular membranes . Arch Ophthalmol . 1987;;105:209-213.
11 +
Freund KB, Yannuzzi LA, Sorenson JA.  Age-related macular degeneration and choroidal neovascularization . Am J Ophthalmol . 1993;;115:786-791.
12 +
Macular Photocoagulation Study Group.  Visual outcome after laser photocoagulation for subfoveal choroidal neovascularization secondary to age-related macular degeneration: the influence of initial lesion size and initial visual acuity . Arch Ophthalmol . 1994;;112:480-488.
13 +
Gunby P.  Ocular histoplasmosis . JAMA . 1980;;243:626-627.
14 +
Macular Photocoagulation Study Group.  Argon laser photocoagulation for ocular histoplasmosis: results from a randomized clinical trial . Arch Ophthalmol . 1983;;101:1347-1357.
15 +
Macular Photocoagulation Study Group.  Krypton laser photocoagulation for neovascular lesions of ocular histoplasmosis: results of a clinical trial . Arch Ophthalmol . 1987;;105:1499-1507.
16 +
Macular Photocoagulation Study Group.  Recurrent choroidal neovascularization after argon laser treatment for neovascular maculopathy . Arch Ophthalmol . 1986;;104:503-512.
17 +
Macular Photocoagulation Study Group.  Persistent and recurrent neovascularization after krypton laser photocoagulation for neovascular lesions of ocular histoplasmosis . Arch Ophthalmol . 1989;;107:344-352.
18 +
Fine SL, Wood WJ, Isernhagen RD, et al.  Laser treatment for subfoveal neovascular membranes in ocular histoplasmosis syndrome: results of a pilot randomized clinical trial . Arch Ophthalmol . 1993;;111:19-20.
19 +
Thomas MS, Grand MG, Williams DF, et al.  Surgical management of subfoveal choroidal neovascularization . Ophthalmology . 1992;;99:952-966.
20 +
Berger AS, Kaplan HJ.  Clinical experience with the surgical removal of subfoveal neovascular membranes . Ophthalmology . 1992;;99:969-976.
21 +
Lambert HM, Capone A, Aaberg TM, et al.  Surgical excision of subfoveal neovascular membranes in age-related macular degeneration . Am J Ophthalmol . 1992;;114:241-242.
22 +
Macular Photocoagulation Study Group.  The influence of treatment extent on the visual acuity of eyes treated with krypton laser for juxtafoveal choroidal neovascularization . Arch Ophthalmol . 1995;;113:190-194.
23 +
Macular Photocoagulation Study Group.  Persistent and recurrent choroidal neovascularization after laser photocoagulation for subfoveal choroidal neovascularization of age-related macular degeneration . Arch Ophthalmol . 1994;;112:489-499.
24 +
Vander JF, Federman JL, Greven C, Slusher MM, Gabel VP.  Surgical removal of massive subretinal hemorrhage associated with age-related macular degeneration . Ophthalmology . 1991;;98:23-27.
25 +
Wade EC, Flynn HW, Olsen KR, Blumenkranz MS, Nicholson DH.  Subretinal hemorrhage management by pars plana vitrectomy and internal drainage . Arch Ophthalmol . 1990;;108:973-978.
26 +
Lewis H.  Management of submacular hemorrhage . In: Lewis H, Ryan SJ, eds. Medical and Surgical Retina . St Louis, Mo: Mosby-Year Book; 1994;:54-62.
27 +
 American Academy of Ophthalmology 1994 Annual Meeting Final Program Abstract Book . Ophthalmology . 1994;;101( (suppl) ):68, 69, 139.
28 +
 The Association for Research in Vision and Ophthalmology Annual Meeting Abstract Book . Invest Ophthalmol Vis Sci . 1994;;35( (ARVO suppl) ):1260, 1504, 1712-1714.
29 +
 The Association for Research in Vision and Ophthalmology Annual Meeting Abstract Book . Invest Ophthalmol Vis Sci . 1995;;36( (ARVO suppl) ):89, 211, 212, 252, 553, 656, 1070.
30 +
Ebert EM, Fine AM, Markowitz J, Maguire MG, Starr JS, Fine SL.  Functional vision in patients with neovascular maculopathy and poor visual acuity . Arch Ophthalmol . 1986;;104:1009-1012.
31 +
Bynoe LA, Chang TS, Funata M, Del Priore LV, Kaplan HJ, Green WR.  Histopathologic examination of vascular patterns in subfoveal neovascular membranes . Ophthalmology . 1994;;104:1112-1117.

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