Abstract
SummaryBackgroundPrimary open angle glaucoma and ocular hypertension are habitually treated with eye drops that lower intraocular pressure. Selective laser trabeculoplasty is a safe alternative but is rarely used as first-line treatment. We compared the two.MethodsIn this observer-masked, randomised controlled trial treatment-naive patients with open angle glaucoma or ocular hypertension and no ocular comorbidities were recruited between 2012 and 2014 at six UK hospitals. They were randomly allocated (web-based randomisation) to initial selective laser trabeculoplasty or to eye drops. An objective target intraocular pressure was set according to glaucoma severity. The primary outcome was health-related quality of life (HRQoL) at 3 years (assessed by EQ-5D). Secondary outcomes were cost and cost-effectiveness, disease-specific HRQoL, clinical effectiveness, and safety. Analysis was by intention to treat. This study is registered at controlled-trials.com (ISRCTN32038223).FindingsOf 718 patients enrolled, 356 were randomised to the selective laser trabeculoplasty and 362 to the eye drops group. 652 (91%) returned the primary outcome questionnaire at 36 months. Average EQ-5D score was 0·89 (SD 0·18) in the selective laser trabeculoplasty group versus 0·90 (SD 0·16) in the eye drops group, with no significant difference (difference 0·01, 95% CI −0·01 to 0·03; p=0·23). At 36 months, 74·2% (95% CI 69·3–78·6) of patients in the selective laser trabeculoplasty group required no drops to maintain intraocular pressure at target. Eyes of patients in the selective laser trabeculoplasty group were within target intracoluar pressure at more visits (93·0%) than in the eye drops group (91·3%), with glaucoma surgery to lower intraocular pressure required in none versus 11 patients. Over 36 months, from an ophthalmology cost perspective, there was a 97% probability of selective laser trabeculoplasty as first treatment being more cost-effective than eye drops first at a willingness to pay of £20 000 per quality-adjusted life-year gained.InterpretationSelective laser trabeculoplasty should be offered as a first-line treatment for open angle glaucoma and ocular hypertension, supporting a change in clinical practice.FundingNational Institute for Health Research, Health and Technology Assessment Programme.
Highlights
Glaucoma is a progressive multifactorial disease characterised by damage to the optic nerve and progressive visual loss that, if left untreated, can lead to blindness
Average EQ-5D score was 0·89 (SD 0·18) in the selective laser trabeculoplasty group versus 0·90 (SD 0·16) in the eye drops group, with no significant difference
Patients were excluded if there were contraindications to selective laser trabeculoplasty, if they were unable to use eye drops, had symptomatic cataract, or were under active treatment for another ophthalmic condition
Summary
Glaucoma is a progressive multifactorial disease characterised by damage to the optic nerve and progressive visual loss that, if left untreated, can lead to blindness. Long-term and mul tiple topical medications are associated with multiple ocular and systemic side-effects, poor patient adherence, and are a risk factor for later surgical failure.[7,8] Selective laser trabeculoplasty reduces intraocular pressure by increasing aqueous outflow through the trabecular meshwork with a single, painless outpatient laser procedure, minimal recovery time, and good safety profile. It was introduced in 1995 and received US FDA approval in 2001, yet is not routinely offered as first-line treatment. The intraocular pressure-lowering effect is comparable to Lancet 2019; 393: 1505–16
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