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Long-term effects of timolol therapy in ocular hypertension : a double-masked, randomised trial

Heijl, A LU and Bengtsson, B LU (2000) In Graefe's Archive for Clinical and Experimental Ophthalmology 238(11). p.83-877
Abstract

BACKGROUND: Increased intraocular pressure (IOP) has been shown to be one of the most important risk factors for developing glaucoma. Yet it has not been clearly demonstrated that IOP-lowering treatment can reduce the incidence of glaucoma damage in patients with ocular hypertension. The aim of the current paper was to report the results of a long-term study addressing this very problem.

METHODS: We conducted a randomised, double-masked study comparing timolol and placebo treatment in 90 patients with ocular hypertension plus some additional risk factor. Patients were followed at 3-month intervals prospectively for 10 years or until glaucomatous field loss could be demonstrated with computerised perimetry. A post-study analysis... (More)

BACKGROUND: Increased intraocular pressure (IOP) has been shown to be one of the most important risk factors for developing glaucoma. Yet it has not been clearly demonstrated that IOP-lowering treatment can reduce the incidence of glaucoma damage in patients with ocular hypertension. The aim of the current paper was to report the results of a long-term study addressing this very problem.

METHODS: We conducted a randomised, double-masked study comparing timolol and placebo treatment in 90 patients with ocular hypertension plus some additional risk factor. Patients were followed at 3-month intervals prospectively for 10 years or until glaucomatous field loss could be demonstrated with computerised perimetry. A post-study analysis was performed including all available data, thus extending maximum follow-up to 17 years.

RESULTS: After 5 years of follow-up eight patients in the placebo group and five patients in the timolol group had developed glaucomatous field loss (NS); the corresponding figures after 10 years were 15 patients in the placebo group and seven patients in the timolol group. Survival analysis showed a tendency but no statistically significant difference between treatment groups (P = 0.07). Study attrition was large. Eighteen patients in each group had developed glaucomatous field loss when also post-study data were included. IOP reduction was greater in eyes passing the 10-year visit without field loss (5.7 mmHg), than in those that reached an end-point (2.3 mmHg; P = 0.0002).

CONCLUSION: In this long-term study we found a tendency but failed to prove a beneficial effect of topical timolol treatment in patients with elevated IOP, normal visual fields and some additional risk factor. The intent-to-treat analysis showed no difference between treatment groups. The high attrition shows the difficulties associated with very long follow-up.

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author
and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Adrenergic beta-Antagonists, Double-Blind Method, Female, Follow-Up Studies, Humans, Intraocular Pressure, Male, Middle Aged, Ocular Hypertension, Optic Disk, Prospective Studies, Risk Factors, Timolol, Tonometry, Ocular, Treatment Outcome, Visual Fields
in
Graefe's Archive for Clinical and Experimental Ophthalmology
volume
238
issue
11
pages
7 pages
publisher
Springer
external identifiers
  • pmid:11148810
  • scopus:0033748355
ISSN
0721-832X
DOI
10.1007/s004170000189
language
English
LU publication?
yes
id
3dabe970-f961-438d-9982-2e9e5d23e54a
date added to LUP
2016-08-30 16:50:56
date last changed
2024-01-04 11:37:07
@article{3dabe970-f961-438d-9982-2e9e5d23e54a,
  abstract     = {{<p>BACKGROUND: Increased intraocular pressure (IOP) has been shown to be one of the most important risk factors for developing glaucoma. Yet it has not been clearly demonstrated that IOP-lowering treatment can reduce the incidence of glaucoma damage in patients with ocular hypertension. The aim of the current paper was to report the results of a long-term study addressing this very problem.</p><p>METHODS: We conducted a randomised, double-masked study comparing timolol and placebo treatment in 90 patients with ocular hypertension plus some additional risk factor. Patients were followed at 3-month intervals prospectively for 10 years or until glaucomatous field loss could be demonstrated with computerised perimetry. A post-study analysis was performed including all available data, thus extending maximum follow-up to 17 years.</p><p>RESULTS: After 5 years of follow-up eight patients in the placebo group and five patients in the timolol group had developed glaucomatous field loss (NS); the corresponding figures after 10 years were 15 patients in the placebo group and seven patients in the timolol group. Survival analysis showed a tendency but no statistically significant difference between treatment groups (P = 0.07). Study attrition was large. Eighteen patients in each group had developed glaucomatous field loss when also post-study data were included. IOP reduction was greater in eyes passing the 10-year visit without field loss (5.7 mmHg), than in those that reached an end-point (2.3 mmHg; P = 0.0002).</p><p>CONCLUSION: In this long-term study we found a tendency but failed to prove a beneficial effect of topical timolol treatment in patients with elevated IOP, normal visual fields and some additional risk factor. The intent-to-treat analysis showed no difference between treatment groups. The high attrition shows the difficulties associated with very long follow-up.</p>}},
  author       = {{Heijl, A and Bengtsson, B}},
  issn         = {{0721-832X}},
  keywords     = {{Adrenergic beta-Antagonists; Double-Blind Method; Female; Follow-Up Studies; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Optic Disk; Prospective Studies; Risk Factors; Timolol; Tonometry, Ocular; Treatment Outcome; Visual Fields}},
  language     = {{eng}},
  number       = {{11}},
  pages        = {{83--877}},
  publisher    = {{Springer}},
  series       = {{Graefe's Archive for Clinical and Experimental Ophthalmology}},
  title        = {{Long-term effects of timolol therapy in ocular hypertension : a double-masked, randomised trial}},
  url          = {{http://dx.doi.org/10.1007/s004170000189}},
  doi          = {{10.1007/s004170000189}},
  volume       = {{238}},
  year         = {{2000}},
}