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Results of the betaxolol versus placebo treatment trial in ocular hypertension

  • Clinical Investigation
  • Published:
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Abstract

Purpose

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.

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Acknowledgements

Funded by The Guide Dogs for the Blind Association, The Blue Light Fund at Moorfields Eye Hospital and unrestricted funds from Alcon.

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Authors and Affiliations

  1. Glaucoma Research Unit, Moorfields Eye Hospital, City Road, London , EC1V 2PD, UK

    Deborah Kamal, Simon Ruben, Fiona O'Sullivan, Anath Viswanathan, Wendy Franks & Roger Hitchings

  2. Glaxo Department of Epidemiology, Moorfields Eye Hospital, City Road, London , EC1V 2PD, UK

    Catey Bunce

Authors
  1. Deborah Kamal
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  2. David Garway-Heath
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  3. Simon Ruben
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  4. Fiona O'Sullivan
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  5. Catey Bunce
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  6. Anath Viswanathan
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  7. Wendy Franks
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  8. Roger Hitchings
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Correspondence to Roger Hitchings.

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Each author states that she/he has no proprietary interest in betaxolol

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Kamal, D., Garway-Heath, D., Ruben, S. et al. Results of the betaxolol versus placebo treatment trial in ocular hypertension. Graefe's Arch Clin Exp Ophthalmol 241, 196–203 (2003). https://doi.org/10.1007/s00417-002-0614-4

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  • DOI: https://doi.org/10.1007/s00417-002-0614-4

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