End-points and Examination Parameters in Glaucoma Studies

¹Yun S. H., ¹Schwenn O., ²Troost R., ¹Pfeiffer N.,
¹Johannes-Gutenberg-Universität Mainz, Universitäts-Augenklinik (Mainz)
²Johannes-Gutenberg-Universität Mainz, Koordinierungszentrum für Klinische Studien (KKS) (Mainz)

Background: Glaucoma is defined as progressive optic neuropathy involving characteristic changes to optic nerve and visual field. It should be evaluated which parameters of examination and success are applied in glaucoma studies.
Method: Total 101 studies on clinical glaucoma therapy from the years 1996 to 1999 in frequently read journals are evaluated.
Results: Intraocular pressure was examined in all studies. The visual field respectively the morphology of optic nerve disc was only examined in 60% respectively 30% of the studies. The assessment of these parameters was often not defined, nonuniform and not easily comparable. In those cases success was explicitly defined, it was mostly defined with the intraocular pressure. The visual field and the morphology of optic nerve disc were endpoints in few studies. New diagnostic methods like laser scanning tomography, laser scanning polarimetry or short-wavelength automated perimetry were not yet in use.
Conclusions: So far, the intraocular pressure plays important role in the concepts of glaucoma studies, although it is not a part of the actual disease defintion. The slow progression makes it difficult to assess the success of a study by changes to visual field and optic nerve disc. New concepts like neuroprotection, improvement of blood supply or gene therapy require other parameters for success assessment.

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