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Results of the betaxolol versus placebo treatment trial in ocular hypertension.

AbstractPURPOSE:
To determine whether treatment with betaxolol can delay or prevent the conversion from ocular hypertension to early glaucoma on the basis of visual field criteria, by means of a prospective, randomised, placebo-controlled trial.
METHODS:
Three hundred and fifty-six ocular hypertensives were randomized to treatment with either betaxolol drops or placebo drops during the period 1992-1996. Each patient was followed prospectively with 4-monthly visits. Examination at each visit included visual field testing, intra-ocular pressure (IOP) measurement and optic disc imaging. Conversion to early glaucoma was defined on the basis of visual field change by AGIS criteria. An intent-to-treat analysis compared visual field conversion after 3 years in the treatment and placebo arms. Normal visual field survival analysis was also performed. The IOP characteristics of the two treatment groups were compared.
RESULTS:
Two hundred and fifty-five patients completed the study, which ended in 1998, with a range of follow-up of 2-6 years. Sixteen (13.2%) of 121 patients in the placebo group converted to glaucoma, compared with 12 (9.0%) of 134 patients in the betaxolol group. The intent-to-treat analysis demonstrated no evidence of any difference in conversion rates between the betaxolol and placebo groups after 3 years. Visual field survival analysis demonstrated no significant difference between the betaxolol and placebo groups. The betaxolol-treated group had significantly lower post-treatment IOP values. Converters had significantly higher pre- and post-treatment IOP values than non-converters.
CONCLUSIONS:
Betaxolol significantly lowered the IOP level compared with placebo. Conversion to glaucoma was found to be related to both the baseline and post-treatment IOP levels. However the intent-to-treat analysis did not demonstrate a statistically significant reduction in the conversion rate in the betaxolol-treated group.
AuthorsDeborah Kamal, David Garway-Heath, Simon Ruben, Fiona O'Sullivan, Catey Bunce, Anath Viswanathan, Wendy Franks, Roger Hitchings
JournalGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie (Graefes Arch Clin Exp Ophthalmol) Vol. 241 Issue 3 Pg. 196-203 (Mar 2003) ISSN: 0721-832X [Print] Germany
PMID12644943 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Adrenergic beta-Antagonists
  • Ophthalmic Solutions
  • Betaxolol
Topics
  • Adrenergic beta-Antagonists (administration & dosage, therapeutic use)
  • Aged
  • Betaxolol (administration & dosage, therapeutic use)
  • Double-Blind Method
  • Female
  • Glaucoma (diagnosis, prevention & control)
  • Humans
  • Intraocular Pressure (drug effects)
  • Male
  • Ocular Hypertension (diagnosis, drug therapy)
  • Ophthalmic Solutions
  • Prospective Studies
  • Visual Fields (drug effects)

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