EARLY MANIFEST GLAUCOMA TRIAL

Summary

Principal Investigator: A Heijl
Abstract: 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.
Funding Period: 1993-06-02 - 2005-05-31
more information: NIH RePORT

Top Publications

  1. ncbi Fluctuation of intraocular pressure and glaucoma progression in the early manifest glaucoma trial
    Boel Bengtsson
    Department of Clinical Sciences, Ophthalmology, Lund University, Malmo University Hospital, Malmo, Sweden
    Ophthalmology 114:205-9. 2007
  2. ncbi Intraocular pressure reduction with a fixed treatment protocol in the Early Manifest Glaucoma Trial
    Anders Heijl
    Department of Ophthalmology, Lund University, Malmo University Hospital, Malmo, Sweden
    Acta Ophthalmol 89:749-54. 2011
  3. pmc Prevalence and severity of undetected manifest glaucoma: results from the early manifest glaucoma trial screening
    Anders Heijl
    Lund University, Department of Clinical Sciences Malmo, Ophthalmology, Skane University Hospital, Malmo, Sweden
    Ophthalmology 120:1541-5. 2013
  4. ncbi Natural history of intraocular pressure in the early manifest glaucoma trial: A 6-year follow-up
    Leslie Hyman
    Division of Epidemiology, Department of Preventive Medicine, Stony Brook University, Stony Brook, NY 11790 8036, USA
    Arch Ophthalmol 128:601-7. 2010
  5. ncbi Effects of argon laser trabeculoplasty in the Early Manifest Glaucoma Trial
    Anders Heijl
    Department of Ophthalmology, Lund University, Skane University Hospital, Malmo, Sweden
    Am J Ophthalmol 152:842-8. 2011
  6. ncbi Treatment and vision-related quality of life in the early manifest glaucoma trial
    Leslie G Hyman
    Department of Preventive Medicine, School of Medicine, Stony Brook University, Health Sciences Center, Stony Brook, New York 11794 8036, USA
    Ophthalmology 112:1505-13. 2005
  7. ncbi Disc hemorrhages and treatment in the early manifest glaucoma trial
    Boel Bengtsson
    Department of Clinical Sciences, Ophthalmology, Lund University, Malmo University Hospital, Sweden
    Ophthalmology 115:2044-8. 2008
  8. pmc Ocular perfusion pressure and glaucoma: clinical trial and epidemiologic findings
    M Cristina Leske
    Department of Preventive Medicine, Stony Brook University, Stony Brook, New York 11794 8036, USA
    Curr Opin Ophthalmol 20:73-8. 2009
  9. ncbi Natural history of open-angle glaucoma
    Anders Heijl
    Department of Ophthalmology, Lund University, Malmo University Hospital, Malmo, Sweden
    Ophthalmology 116:2271-6. 2009

Detail Information

Publications9

  1. ncbi Fluctuation of intraocular pressure and glaucoma progression in the early manifest glaucoma trial
    Boel Bengtsson
    Department of Clinical Sciences, Ophthalmology, Lund University, Malmo University Hospital, Malmo, Sweden
    Ophthalmology 114:205-9. 2007
    ..To investigate whether increased fluctuation of intraocular pressure (IOP) is an independent factor for glaucoma progression...
  2. ncbi Intraocular pressure reduction with a fixed treatment protocol in the Early Manifest Glaucoma Trial
    Anders Heijl
    Department of Ophthalmology, Lund University, Malmo University Hospital, Malmo, Sweden
    Acta Ophthalmol 89:749-54. 2011
    ..Results are based on 128 patients with glaucoma with field defects, who were randomized to the treatment arm of the Early Manifest Glaucoma Trial (EMGT).
  3. pmc Prevalence and severity of undetected manifest glaucoma: results from the early manifest glaucoma trial screening
    Anders Heijl
    Lund University, Department of Clinical Sciences Malmo, Ophthalmology, Skane University Hospital, Malmo, Sweden
    Ophthalmology 120:1541-5. 2013
    ..To estimate the prevalence and severity of undetected glaucoma in the population...
  4. ncbi Natural history of intraocular pressure in the early manifest glaucoma trial: A 6-year follow-up
    Leslie Hyman
    Division of Epidemiology, Department of Preventive Medicine, Stony Brook University, Stony Brook, NY 11790 8036, USA
    Arch Ophthalmol 128:601-7. 2010
    ..during 6 years of follow-up among patients with early, newly diagnosed glaucoma randomized to no initial treatment in the Early Manifest Glaucoma Trial (control group) and to evaluate factors associated with IOP changes in this group.
  5. ncbi Effects of argon laser trabeculoplasty in the Early Manifest Glaucoma Trial
    Anders Heijl
    Department of Ophthalmology, Lund University, Skane University Hospital, Malmo, Sweden
    Am J Ophthalmol 152:842-8. 2011
    To analyze reduction of intraocular pressure (IOP) by argon laser trabeculoplasty (ALT) in the Early Manifest Glaucoma Trial and factors influencing the effect of such treatment.
  6. ncbi Treatment and vision-related quality of life in the early manifest glaucoma trial
    Leslie G Hyman
    Department of Preventive Medicine, School of Medicine, Stony Brook University, Health Sciences Center, Stony Brook, New York 11794 8036, USA
    Ophthalmology 112:1505-13. 2005
    ..To evaluate the effect of treatment, visual function, and other factors on vision-targeted health-related quality of life (HRQOL) of patients with early glaucoma...
  7. ncbi Disc hemorrhages and treatment in the early manifest glaucoma trial
    Boel Bengtsson
    Department of Clinical Sciences, Ophthalmology, Lund University, Malmo University Hospital, Sweden
    Ophthalmology 115:2044-8. 2008
    ..To evaluate the effect of intraocular pressure (IOP)-reducing treatment on the development of disc hemorrhages in patients with glaucoma...
  8. pmc Ocular perfusion pressure and glaucoma: clinical trial and epidemiologic findings
    M Cristina Leske
    Department of Preventive Medicine, Stony Brook University, Stony Brook, New York 11794 8036, USA
    Curr Opin Ophthalmol 20:73-8. 2009
    ..This review summarizes the scientific rationale for the proposed relationship, presents recent data, and outlines potential implications...
  9. ncbi Natural history of open-angle glaucoma
    Anders Heijl
    Department of Ophthalmology, Lund University, Malmo University Hospital, Malmo, Sweden
    Ophthalmology 116:2271-6. 2009
    This article, based on the Early Manifest Glaucoma Trial (EMGT), provides prospective natural history data on progression of glaucomatous field defects in 3 of the most common glaucoma types.