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OBJECTIVES: To determine whether the types and rates of post-surgical complications associated with the Port Delivery System with ranibizumab (PDS) are comparable with those reported for other ocular implants that cross the sclera. METHODS: Systematic literature reviews were conducted to determine the long-term (≥ 18-month) safety of ocular implants that cross the sclera in clinical trials and real-world studies. Complication types and rates were compared with those reported for the PDS in phase III clinical trials (Archway, Pagoda, and Pavilion). RESULTS: Sixteen clinical trials (24 publications) and 43 real-world studies were identified reporting 30 complications in eyes with 15 implant types and 8 ocular diseases. Implants were associated with an acceptable, well-characterized safety profile, with most complications resolving spontaneously or with treatment. Device-related complications were reported in 0.7% (0.0-5.0%) of study eyes in clinical trials and 1.3% (0.0-14.5%) of eyes in real-world studies. Rates of conjunctival complications were 2.1% (0.0-22.8%) and 2.2% (0.9-4.6%), respectively. The overall types and rates of adverse events of special interest reported for the PDS in phase III trials (cataract, conjunctival bleb, vitreous hemorrhage, conjunctival erosion, conjunctival retraction, endophthalmitis, implant dislocation, retinal detachment, and hyphema) were within the ranges reported for other ocular implants. CONCLUSIONS: The rates of complications reported in phase III clinical trials for the PDS were within the ranges reported for other ocular implants that cross the sclera. This suggests that the long-term safety of the PDS is consistent with other ocular devices established in ophthalmology clinical practice. TRIAL REGISTRATION: PROSPERO international prospective register of systematic reviews: CRD5202234129, CRD42022343129.
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PURPOSE: The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial demonstrated the efficacy and safety of selective laser trabeculoplasty (SLT) compared to topical hypotensive medication as 1st-line therapy for ocular hypertension and open angle glaucoma. This sub-study explores the impact of pre-treatment (baseline) intraocular pressure (IOP) on treatment response for SLT and medication. DESIGN: Post hoc analysis of randomised control trial data. PARTICIPANTS: 1146 eyes from 662 patients were included in this analysis: 559 eyes in the SLT group and 587 in the medication group. METHODS: IOP reduction at 8 weeks following treatment with either SLT or prostaglandin analogue (PGA) eye drop initiation was assessed at different levels of baseline IOP, and the groups were compared. Differences in absolute and percentage IOP lowering between SLT and PGA medication were tested with a linear mixed effects model. Differences in the probability of achieving ≥20% IOP lowering between SLT and PGA medication, at different levels of baseline IOP, was estimated using a logistic mixed effects model. MAIN OUTCOME MEASURE: IOP lowering response to SLT versus PGA eye drops. RESULTS: Mean IOP was not significantly different between the groups, at baseline or 8 weeks following treatment initiation. Both treatments showed greater IOP lowering at higher baseline IOP and less IOP lowering at lower baseline IOP. SLT tended to achieve more IOP lowering than PGA drops at higher baseline IOP. PGA drops performed better at lower baseline IOP, and the difference compared to SLT, in terms of percentage IOP reduction, was significant at baseline IOP ≤ 17 mmHg. There was a significant difference in the relationship between baseline IOP and probability of ≥20% IOP lowering between the two treatments (p = 0.01), with SLT being more successful than PGA at baseline IOP > 22.51 mmHg. CONCLUSIONS: These data confirm previous reports of greater IOP lowering with higher baseline IOP for both SLT and topical hypotensive medication. In treatment naïve eyes, at higher baseline IOP, SLT was more successful at achieving ≥20% IOP lowering than PGA drops. At lower baseline IOP, a statistically greater percentage, but not absolute, IOP lowering was seen with PGA drops compared to SLT, although the clinical significance of this is uncertain.
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Over the last decade, the delivery of glaucoma care in the UK has changed dramatically, with more non-medical ophthalmic practitioners involved in the care of glaucoma patients. Optometrists and other non-medical professionals are now involved in the delivery of laser treatments in the Hospital Eye Service (HES), but there is currently no standardised national training framework for non-medical clinicians. Moorfields Eye Hospital and UCL's Institute of Ophthalmology have developed and delivered an education and training programme for the delivery of lasers, including Selective Laser Trabeculoplasty (SLT) by non-medical ophthalmic practitioners. The training programme is based on medical education principles, is informed by previous qualitative research into the role of ophthalmic practitioners in the delivery of laser treatments and is expected to have multidisciplinary benefits for ophthalmic healthcare. Clinical audit data indicate that optometrists can deliver safe SLT treatments, adhering to local protocols.
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OBJECTIVES: To assess whether patients from minority ethnic groups have different perceptions about the quality-of-life outcomes that matter most to them. DESIGN: Cross-sectional observational study. SETTING: High volume eye centres serving the most ethnically diverse region in the UK, recruiting from July 2021 to February 2022. PARTICIPANTS: 511 patients with primary open-angle glaucoma and the predisease state of ocular hypertension. MAIN OUTCOME MEASURES: The main outcome was participants' self-reported priorities for health outcomes. RESULTS: Participants fell into one of four clusters with differing priorities for health outcomes, namely: (1) vision, (2) drop freedom, (3) intraocular pressure and (4) one-time treatment. Ethnicity was the strongest determinant of cluster membership after adjusting for potential confounders. Compared with white patients prioritising vision alone, the OR for black/black British patients was 7.31 (95% CI 3.43 to 15.57, p<0.001) for prioritising drop freedom; 5.95 (2.91 to 12.16, p<0.001) for intraocular pressure; and 2.99 (1.44 to 6.18, p=0.003) for one-time treatment. For Asian/Asian British patients, the OR was 3.17 (1.12 to 8.96, p=0.030) for prioritising intraocular pressure as highly as vision. Other ethnic minority groups also had higher ORs for prioritising health outcomes other than vision alone: 4.50 (1.03 to 19.63, p=0.045) for drop freedom and 5.37 (1.47 to 19.60, p=0.011) for intraocular pressure. CONCLUSIONS: Ethnicity is strongly associated with differing perceptions about the health outcomes that matter. An individualised and ethnically inclusive approach is needed when selecting and evaluating treatments in clinical and research settings.