| Methods |
Allocation: randomised (set of sequentially numbered, opaque, sealed envelopes provided by a Data centre)
Masking: computerised visual field and fundus photographs read by masked graders (Disc Photography Reading Center). IOP evaluator was also masked (and the status of collecting data was recorded at each study visit)
Follow‐up: at least 4 years
Centres: 2 clinical, 1 reading and 1 co‐ordinating
ITT analysis: used
Randomisation: January 1993 to April 1997 |
| Participants |
N = 255 participants (if possible both eyes with correction of correlation between fellow eyes)
Diagnosis: Men and women with newly diagnosed, previously untreated COAG (primary, normal tension, exfoliative glaucoma). The diagnosis required repeatable visual fields defects in at least one eye, detected by static computerised perimetry (Humphrey 24‐2 Full‐Threshold program).
Exclusion criteria included: advanced visual field defects (MD ‐16 dB or threat to fixation), visual acuity less than 0.5, mean IOP greater than 30 mmHg, lens opacities exceeding N1, C1 or P1 in the Lens Opacities Classification System II. Participants with glaucomatous visual field defect in both eyes eligible only if MD ‐10dB or better in one eye and ‐16dB in the other eye
Age: mean 68.1 years (4.9)
Race: not mentioned, but probably 100% white
History: 20% had family history of glaucoma, 38% had systemic hypertension, 6% had myocardial infarction, 4% had diabetes, 9% had vasospasm, 10% had migraine
24% had both eyes eligible |
| Interventions |
1. No treatment (n = 126)
2. Betaxolol and ALT, performed one week after inclusion (n = 129)
Technique: full 360 degree ALT was administered
If the eligible eye achieved 25 mmHg in 2 consecutive visits or the other eye 35 mmHg in 1 visit, latanoprost 50 micrograms/ml was administered once daily |
| Outcomes |
Primary: glaucoma progression (visual field changes or optic disk changes). Visual field progression was defined as worsening of 3 consecutive points in the Glaucoma Change Probability map, confirmed in 3 consecutive visual fields. Optic disc progression should be detected by a masking reader in a flicker chronoscopy and side by side comparison in 2 consecutive visits
Secondary: explore natural history, explore the factors that may influence progression, change in IOP over time, vision‐related quality of life |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
