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Evidence Table 4Beta-blockers vs. no treatment

Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Vass et al., 2007155

Study design:
Systematic Review

Evidence level: 1++

Duration of follow-up: Minimum treatment 12 months (range 12 months to 10 years).
Patient group: All people with Ocular Hypertension (POAG patients included but all the studies in this category were in OHT patients).

Inclusion criteria: Minimum treatment duration 1 year. People with a mean IOP above 21 mm Hg.

Exclusion criteria: Patients with Normal Tension Glaucoma. Trials excluded on methodology if graded inadequate on allocation concealment.

All patients
N: 4979 from 26 trials
Age (mean): NR
M/F: NR
Drop outs: NR
Caucasian: 2907
African: 562
Hispanic: 59
Asian: 15
Race NR: 16 trials
Sample range: 18–1636
Group 1
Beta-blocker

Group 2
Placebo or no treatment.
Incidence of visual field defect progression: (OHT patients)Group1 (beta-blocker): 45/469 (9.6%)
Group 2 (placebo/untreated):
64/466 (13.7%)
Peto OR: 0.67 (95% CI: 0.45, 1.00);
8 studies
Heterogeneity: Chi2=4.00, df=6 (P=0.68), I2=0%
Funding: Department of Ophthalmology and Clinical Pharmacology, University of Vienna

Limitations:
IOP change from baseline not reported as an outcome
Quality assessment not reported in detail for each trial

Additional outcomes:
Interclass comparisons.
Sensitivity analysis also conducted to determine the effect of excluding trials falling below a quality threshold with either exclusion of trials scoring C (inadequate) on any aspect of methodological trial quality or exclusion of trials which had assumed that eyes within an individual were independent (fellow eye used as a control group).

Notes:
Studies included in Vass 2007 that do not meet guideline inclusion criteria because eyes were randomised
Wishart & Batterbury, 1992 and Kass et al., 1989
Sensitivity analysisGroup 1: 18/253
Group 2: 26/246
OR: 0.64 (95% CI: 0.34, 1.19);
4 studies
Heterogeneity: Chi2=0.17, df=2 (P=0.92), I2=0%
Drop outs due to drug related adverse events:Group1: 17/255
Group 2: 14/248
Peto OR: 1.24 (95% CI: 0.59, 2.58);
4 studies
Heterogeneity: Chi2=2.05, df=2 (P=0.36), I2=2.4%
Long-term studies concerning incidence of visual field progression (follow-up of at least 3 years):Group1: 44/444
Group 2: 62/438
Peto OR: 0.67 (95% CI: 0.45, 1.01);
6 studies
Heterogeneity: Chi2=3.91, df=5 (P=0.56), I2=0%
RCTs included in VASS 2007 that meet guideline inclusion criteria
STUDYInterventionDurationFundingPopulation Disease severitySize N - patientsAge (mean/ range)Mean Baseline IOP mmHg% Afro- Caribbean / % Family HistoryQuality CheckNotes
Epstein et al., 198942 [USA]Timolol 0.5% 2/day
v
No treatment

5 years
Glaucoma
Clinical
Centre & MSD
OHT10760BB: 24.0 ± 1.3
NT: 23.9 ± 1.6
10 / 62Randomisation Method: NR
Allocation concealment: N
Masked outcome assessment: Y
Incomplete outcome data: N
Moderate risk of bias
No IOP figures, estimate from graph.
Open label
No previous treatment.
VF defects using Goldmann or Octopus perimeters
Heijl & Bengtsson, 200058 [Sweden]Timolol 0.5% 2/day
v
Placebo

10 years
MSD, Järnhardt
Foundation & Malmö Hospital
OHT (30% PEX or PG)9063BB: 27.1 ± NR
NT: 26.2 ± NR
NR / 38Randomisation method: Y
Allocation concealment: Y
Masked outcome assessment: Y
Incomplete outcome data: N
Low risk of bias
Eyes with previous antiglaucoma therapy were permitted with a wash-out of 2 weeks.
Kamal et al., 200369 [UK]Betaxolol 0.5% 2/day
v
Placebo

5 years
Guide Dogs for the Blind, Blue Light Fund & AlconOHT35666 (>35)BB: 26.3 ± 2.3
NT: 25.6 ± 2.2
NR / NRRandomisation method: Y
Allocation concealment: Y
Masked outcome assessment: Y
Incomplete outcome data: N
Low risk of bias
No previous treatment.
Conversion to glaucoma defined by AGIS criteria
Kitazwa, 199076 [Japan]Timolol 0.5% 2/day
v
Placebo

2 years
NROHT20NRNRNR / NRRandomisation method: NR
Allocation concealment: NR
Masked outcome assessment: NR
Incomplete outcome data: N
High risk of bias
No IOP data. Study does not report whether treatment was 1st option
VF defects using Humphrey perimeter
Schulzer et al., 1991131 [Canada]Timolol 0.25% - 0.5% 2/day
v
No Treatment

6 years
MSD & Canadian MRCOHT13760 (>45)BB: 26.3 ± 3.5
NT: 26.1 ± 3.2
NR / 31Randomisation method: NR
Allocation concealment: NR
Masked outcome assessment: Y
Incomplete outcome data: N
Moderate risk of bias
Open label
No previous treatment.
VF defects using Goldmann or Octopus perimeters
Schwartz et al., 1995134 [USA]Timolol 0.5% 2/day
v
Placebo
1 to 2 yearsMSDOHT (43% PEX or PG)3760BB: 23.1 ± 2.5
NT: 23.7 ± 3.6
8 / 22Randomisation method: Y
Allocation concealment: NR
Masked outcome assessment: Y
Incomplete outcome data: N
Low risk of bias
Results by presented by eye
No previous treatment.
VF defects using Goldmann perimeter

Abbreviations: NR=not reported, M/F=male/female, NA=not applicable, N=total number of patients randomised, SD=Standard Deviation, CI95%= 95% Confidence Interval, ITT=Intention to Treat

From: Appendix D, Evidence tables

Cover of Glaucoma
Glaucoma: Diagnosis and Management of Chronic Open Angle Glaucoma and Ocular Hypertension.
NICE Clinical Guidelines, No. 85.
National Collaborating Centre for Acute Care (UK).
Copyright © 2009, National Collaborating Centre for Acute Care.

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