Original ArticlesComparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures☆
Section snippets
Patients and methods
Two hundred and thirty patients from 24 centers were enrolled in the study. The study was approved by the ethics committees of all the participating centers, and all patients signed written consent forms after the study was explained. A monitoring and safety committee regularly inspected the data for statistically significant outcomes and possible adverse events.
To be included, patients had to have unilateral or bilateral normal-tension glaucoma with optic disk abnormalities and visual field
Results
Two hundred and thirty eyes were enrolled in the study. All 145 eyes of 145 patients meeting the randomization criteria by virtue of showing progression as defined or having a threat to fixation at the time of recruitment were randomized. Five eyes in the treatment group were randomized but withdrew from the study before their intraocular pressure stabilized and therefore provided no information for this part of the study. They are, however, included in the subsequent intent-to-treat analysis.
Discussion
Shortly after the introduction of the ophthalmoscope, when the cupping of the optic nerve head was recognized as a feature of glaucomatous optic neuropathy, von Graefe20 recognized the existence of optic nerve head abnormality, with disturbances of vision, with digitally estimated normal intraocular pressure. His colleagues so severely criticized this concept that he later recanted but continued to stress that different optic nerves might have different susceptibilities to intraocular pressure.
Collaborative normal-tension glaucoma study group
Statistical design, consultation and analysis was carried out by Michael Schulzer, MD, PhD. Departments of Medicine & Biostatistics, University of British Columbia.
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The study was generously funded by the Glaucoma Research Foundation, with special grants from the Oxnard Foundation and the Edward J. Daly Foundation, San Francisco, California.
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The members of the Collaborative Normal-Tension Glaucoma Study Group are listed at the end of the article.