Summary Background Primary 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. Methods In 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). Findings Of 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. Interpretation Selective laser trabeculoplasty should be offered as a first-line treatment for open angle glaucoma and ocular hypertension, supporting a change in clinical practice. Funding National Institute for Health Research, Health and Technology Assessment Programme.
on behalf of the Laser in Glaucoma and Ocular Hypertension Trial Study Group* Purpose: To determine the efficacy of repeat selective laser trabeculoplasty (SLT) in medication-naive openangle glaucoma (OAG) and ocular hypertensive (OHT) patients requiring repeat treatment for early to mediumterm failure during the Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. Design: Post hoc analysis of SLT treatment arm of a multicenter prospective randomized controlled trial. Participants: Treatment-naive OAG or OHT requiring repeat 360-degree SLT within 18 months. Retreatment was triggered by predefined IOP and disease-progression criteria (using objective individualized target IOPs). Methods: After SLT at baseline, patients were followed for a minimum of 18 months after second (repeat) SLT. A mixed-model analysis was performed with the eye as the unit of analysis, with crossed random effects to adjust for correlation between fellow eyes and repeated measures within eyes. KaplaneMeier curves plot the duration of effect. Main Outcome Measures: Initial (early) IOP lowering at 2 months and duration of effect after initial and repeat SLT. Results: A total of 115 eyes of 90 patients received repeat SLT during the first 18 months of the trial. Pretreatment IOP before initial SLT was significantly higher than before retreatment IOP of repeat SLT (mean difference, 3.4 mmHg; 95% confidence interval [CI], 2.6e4.3 mmHg; P < 0.001). Absolute IOP reduction at 2 months was greater after initial SLT compared with repeat SLT (mean difference, 1.0 mmHg; 95% CI, 0.2e1.8 mmHg; P ¼ 0.02). Adjusted absolute IOP reduction at 2 months (adjusting for IOP before initial or repeat laser) was greater after repeat SLT (adjusted mean difference, À1.1 mmHg, 95% CI, À1.7 to À0.5 mmHg; P ¼ 0.001). A total of 34 eyes were early failures (retreatment 2 months after initial SLT) versus 81 later failures (retreatment >2 months after initial SLT). No significant difference in early absolute IOP reduction at 2 months after repeat SLT was noted between early and later failures (mean difference, 0.3 mmHg; 95% CI, À1.1 to 1.8 mmHg; P ¼ 0.655). Repeat SLT maintained drop-free IOP control in 67% of 115 eyes at 18 months, with no clinically relevant adverse events. Conclusions: These exploratory analyses demonstrate that repeat SLT can maintain IOP at or below target IOP in medication-naive OAG and OHT eyes requiring retreatment with at least an equivalent duration of effect to initial laser.
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