The Early Manifest Glaucoma Trial is intended to study whether and to what extent current standard therapy, reduction of the intraocular pressure, influences the course of chronic open angle glaucoma. It is a prospective, randomized study in which two groups of patients, one treated with laser trabeculoplasty and betaxolol and the other untreated, are closely followed with computerized perimetry and fundus photography. The project has been reviewed and approved by the Swedish Medical Research Council (051192) and by the Ethics Committee of the Medical Faculty of the University of Lund (061592). Funding has been obtained for an open study on 200 participants to be carried out at the Department of Ophthalmology at the General Hospital of Malmo, Sweden. Preliminary studies of screening methods begun in 1991. Recruitment for the trial started October 5 1992. The present application is requesting support for a number of modifications intended to strengthen the original study plan. They include: - a major increase in the number of participants (from 200 to over 300). This would improve the power of the study to detect a limited but clinically meaningful effect (from approximately 70 to 90 per cent) at the cost of a greatly expanded community screening effort. - the incorporation of a masking protocol intended to minimize potential sources of bias - the employment of a clinic coordinator - the establishment of an independent disc reading center - the participation of an independent data center with responsibilities described in a separate application. - the participation of an independent data and safety monitoring committee. It is expected, that the large scale community screening effort to recruit study participants with as yet undetected glaucoma, will require screening of 20,000 to 30,000 Malmo citizens in appropriate age groups.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY010260-07
Application #
2888431
Study Section
Special Emphasis Panel (SRC (01))
Project Start
1993-06-02
Project End
2003-05-31
Budget Start
1999-06-01
Budget End
2000-05-31
Support Year
7
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Lund University
Department
Type
DUNS #
350582417
City
Lund
State
Country
Sweden
Zip Code
SE-22-100
Öhnell, HannaMaria; Heijl, Anders; Brenner, Lena et al. (2016) Structural and Functional Progression in the Early Manifest Glaucoma Trial. Ophthalmology 123:1173-80
Bengtsson, Boel; Heijl, Anders (2016) Lack of Visual Field Improvement After Initiation of Intraocular Pressure Reducing Treatment in the Early Manifest Glaucoma Trial. Invest Ophthalmol Vis Sci 57:5611-5615
Peters, Dorothea; Heijl, Anders; Brenner, Lena et al. (2015) Visual impairment and vision-related quality of life in the Early Manifest Glaucoma Trial after 20 years of follow-up. Acta Ophthalmol 93:745-52
Heijl, Anders; Bengtsson, Boel; Oskarsdottir, Sigridur Erla (2013) Prevalence and severity of undetected manifest glaucoma: results from the early manifest glaucoma trial screening. Ophthalmology 120:1541-5
Heijl, Anders; Leske, M Cristina; Hyman, Leslie et al. (2011) Intraocular pressure reduction with a fixed treatment protocol in the Early Manifest Glaucoma Trial. Acta Ophthalmol 89:749-54
Heijl, Anders; Peters, Dorothea; Leske, M Cristina et al. (2011) Effects of argon laser trabeculoplasty in the Early Manifest Glaucoma Trial. Am J Ophthalmol 152:842-8
Hyman, Leslie; Heijl, Anders; Leske, M Cristina et al. (2010) Natural history of intraocular pressure in the early manifest glaucoma trial: A 6-year follow-up. Arch Ophthalmol 128:601-7
Heijl, Anders; Bengtsson, Boel; Hyman, Leslie et al. (2009) Natural history of open-angle glaucoma. Ophthalmology 116:2271-6
Leske, M Cristina (2009) Ocular perfusion pressure and glaucoma: clinical trial and epidemiologic findings. Curr Opin Ophthalmol 20:73-8
Bengtsson, Boel; Leske, M Cristina; Yang, Zhongming et al. (2008) Disc hemorrhages and treatment in the early manifest glaucoma trial. Ophthalmology 115:2044-8

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