Managing risk in the face of adversity: design and outcomes of rapid glaucoma assessment clinics during a pandemic recovery.

BACKGROUND: The provision of timely care to the high volume of glaucoma patients stratified as "low risk" following pandemic-related appointment deferrals continues to prove challenging for glaucoma specialists. It is unknown whether stratification as "low risk" remains valid over time, raising the potential risk of harm during this period if left unmonitored. This study aimed to evaluate whether Rapid Glaucoma Assessment Clinics (RGACs) are an effective method of assessing "low-risk" patients in order to identify those who may need an escalation of care, therefore reducing the risk of the future incidents of preventable vision loss. METHODS: RGACs were developed which comprised a brief advance telephone history by a clinician and then ophthalmic technician-measured visual acuity and intraocular pressure in clinic. We report outcomes from the first month of operation describing attendance patterns, the proportion of patients from this "low risk" cohort requiring escalation and underlying reasons for treatment escalations. RESULTS: 639 patients were invited to attend RGACs. 75% attended their booked appointment. Pre-attendance telephone consultations were associated with lower non-attendance rates (13.9% vs 29.3%, p < 0.00001). 15% of patients were no longer deemed to remain at "low risk" with further expedited clinical review scheduled. 10.4% of patients required an escalation in treatment following review. CONCLUSIONS: RGACs are an effective approach to deliver high throughput clinical assessments for large numbers of "low-risk" glaucoma patients with deferred appointments. They enable the rapid identification and treatment of patients who would otherwise face significantly delayed review reducing the risk of future preventable vision loss.

Selective laser trabeculoplasty versus drops for newly diagnosed ocular hypertension and glaucoma: the LiGHT RCT.

BACKGROUND: Newly diagnosed open-angle glaucoma (OAG) and ocular hypertension (OHT) are habitually treated with intraocular pressure (IOP)-lowering eyedrops. Selective laser trabeculoplasty (SLT) is a safe alternative to drops and is rarely used as first-line treatment. OBJECTIVES: To compare health-related quality of life (HRQoL) in newly diagnosed, treatment-naive patients with OAG or OHT, treated with two treatment pathways: topical IOP-lowering medication from the outset (Medicine-1st) or primary SLT followed by topical medications as required (Laser-1st). We also compared the clinical effectiveness and cost-effectiveness of the two pathways. DESIGN: A 36-month pragmatic, unmasked, multicentre randomised controlled trial. SETTINGS: Six collaborating specialist glaucoma clinics across the UK. PARTICIPANTS: Newly diagnosed patients with OAG or OHT in one or both eyes who were aged ≥ 18 years and able to provide informed consent and read and understand English. Patients needed to qualify for treatment, be able to perform a reliable visual field (VF) test and have visual acuity of at least 6 out of 36 in the study eye. Patients with VF loss mean deviation worse than -12 dB in the better eye or -15 dB in the worse eye were excluded. Patients were also excluded if they had congenital, early childhood or secondary glaucoma or ocular comorbidities; if they had any previous ocular surgery except phacoemulsification, at least 1 year prior to recruitment or any active treatment for ophthalmic conditions; if they were pregnant; or if they were unable to use topical medical therapy or had contraindications to SLT. INTERVENTIONS: SLT according to a predefined protocol compared with IOP-lowering eyedrops, as per national guidelines. MAIN OUTCOME MEASURES: The primary outcome was HRQoL at 3 years [as measured using the EuroQol-5 Dimensions, five-level version (EQ-5D-5L) questionnaire]. Secondary outcomes were cost and cost-effectiveness, disease-specific HRQoL, clinical effectiveness and safety. RESULTS: Of the 718 patients enrolled, 356 were randomised to Laser-1st (initial SLT followed by routine medical treatment) and 362 to Medicine-1st (routine medical treatment only). A total of 652 (91%) patients returned the primary outcome questionnaire at 36 months. The EQ-5D-5L score was not significantly different between the two arms [adjusted mean difference (Laser-1st - Medicine-1st) 0.01, 95% confidence interval (CI) -0.01 to 0.03; p = 0.23] at 36 months. Over 36 months, the proportion of visits at which IOP was within the target range was higher in the Laser-1st arm (93.0%, 95% CI 91.9% to 94.0%) than in the Medicine-1st arm (91.3%, 95% CI 89.9% to 92.5%), with IOP-lowering glaucoma surgery required in 0 and 11 patients, respectively. There was a 97% probability of Laser-1st being more cost-effective than Medicine-1st for the NHS, at a willingness to pay for a quality-adjusted life-year of £20,000, with a reduction in ophthalmology costs of £458 per patient (95% of bootstrap iterations between -£585 and -£345). LIMITATION: An unmasked design, although a limitation, was essential to capture any treatment effects on patients' perception. The EQ-5D-5L questionnaire is a generic tool used in multiple settings and may not have been the most sensitive tool to investigate HRQoL. CONCLUSIONS: Compared with medication, SLT provided a stable, drop-free IOP control to 74.2% of patients for at least 3 years, with a reduced need for surgery, lower cost and comparable HRQoL. Based on the evidence, SLT seems to be the most cost-effective first-line treatment option for OAG and OHT, also providing better clinical outcomes. FUTURE WORK: Longitudinal research into the clinical efficacy of SLT as a first-line treatment will specify the long-term differences of disease progression, treatment intensity and ocular surgery rates between the two pathways. TRIAL REGISTRATION: Current Controlled Trials ISRCTN32038223. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 31. See the NIHR Journals Library website for further project information.

Glaucoma is an eye condition in which the optic nerve becomes damaged and, if left untreated, will lead to loss of vision. Ocular hypertension (OHT) is the medical name for high pressure in the eye that increases the risk of getting glaucoma. Lowering the eye pressure is the only known way to prevent glaucoma from getting worse. Before this trial, the standard initial treatment of these conditions was the prescription of eyedrops to lower the pressure in the eye. An alternative is a laser therapy that is known to reduce the eye pressure. This study investigated if starting treatment of glaucoma or OHT with laser therapy (using eyedrops later, if needed) affected the patients' quality of life (QoL) more or less than starting treatment with eyedrops alone. The study also investigated if initial treatment with laser and initial treatment with eyedrops are equally good at controlling eye pressure and are equally safe and how much they cost the NHS. Patients were randomly assigned to starting treatment with either laser or eyedrops and the two groups were then compared. The study found that for the first 3 years QoL was similar regardless of treatment. However, three-quarters of patients initially treated with laser did not need any eyedrops to control their eye pressure for 3 years. Patients initially treated with laser were less likely to require cataract surgery, and none needed any glaucoma surgery in the first 3 years. In contrast, among those patients treated with eyedrops, glaucoma surgery was required in 11 eyes (out of 622 eyes). Initial treatment with laser was cheaper than initial treatment with eyedrops. The results of this study suggest that laser is an efficient, safe and cheaper alternative to eyedrops, and that three-quarters of the patients initially treated with laser do not need any eyedrops for the first 3 years of treatment.

Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial.

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.

Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology.

PURPOSE: The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT). DESIGN: The LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis. CONCLUSIONS: The LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication. TRIAL REGISTRATION NUMBER: ISRCTN32038223, Pre-results.

The Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre randomised controlled trial: baseline patient characteristics.

PURPOSE: The laser in glaucoma and ocular hypertension (LiGHT) trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open angle glaucoma (POAG) or ocular hypertension (OHT). DESIGN: LiGHT is a prospective unmasked, multicentre, pragmatic, randomised controlled trial (RCT). PARTICIPANTS: 718 previously untreated patients with POAG or OHT were recruited at 6 UK centres between 2012 and 2014. METHODS: Patients were randomised to initial SLT followed by medical therapy or medical therapy without laser. Participants will be monitored for 3 years, according to routine clinical practice. The primary outcome is EQ-5D-5L. Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index (GUI), Glaucoma Symptom Scale, Glaucoma Quality of Life (GQL), pathway effectiveness, visual function, safety and concordance. RESULTS: A total of 555 patients had POAG and 163 OHT; 518 patients had both eyes eligible. The mean age for patients with POAG was 64 years and for OHT 58 years. 70% of all participants were white. Median IOP for OHT eyes was 26 mm Hg and 23 mm Hg for POAG eyes. Median baseline visual field mean deviation was -0.81 dB for OHT eyes and -2.82 dB for POAG eyes. There was no difference between patients with POAG and patients with OHT on the EQ-5D-5DL; the difference between OHT and POAG on the GUI was -0.02 and 1.23 on the GQL. CONCLUSIONS: The LiGHT trial is the first RCT to compare the two treatment options in a real-world setting. The baseline characteristics of the LiGHT cohort compare well with other landmark glaucoma studies. TRIAL REGISTRATION NUMBER: ISRCTN32038223, Pre-results.

Age and sex variation in angle findings among normal Chinese subjects: a comparison of UBM, Scheimpflug, and gonioscopic assessment of the anterior chamber angle.

BACKGROUND: Limited data are published on the ultrasound biomicroscope (UBM) findings of the anterior chamber angle. This work provides a population-based assessment of angle findings and compares 3 modalities for assessing angle dimensions. METHODS: A sample of 268 persons who had participated in a population-based study of glaucoma prevalence in Singapore were reexamined by UBM (nasal, temporal, and inferior angles only), Scheimpflug photography of angle width, and gonioscopy. Angle findings were compared, and age and sex influences evaluated. RESULTS: The temporal angle was the widest of the 3 angles imaged with the UBM, and the inferior angle was the narrowest (nearly 20% more narrow than the temporal angle, P<0.005). Women were found to have narrower angles than men and older persons had more narrow angles. Scheimpflug photography did not provide enough detail of the angle to increase our understanding of angle anatomy. CONCLUSIONS: The data reported support earlier findings that the anterior chamber angle is narrower in older individuals and women. Methods of assessing the angle may themselves influence the appearance of the angle. Limited agreement exists between the angle quantification methods studied. An ideal method of angle assessment would not contact the eye and would not require light be directed at the eye.

Utility values in Singapore Chinese adults with primary open-angle and primary angle-closure glaucoma.

PURPOSE: To evaluate utility values in Chinese glaucoma patients. PATIENT AND METHODS: Singapore Chinese residents (n = 213) with primary open-angle glaucoma or primary angle-closure glaucoma were recruited from a single tertiary ophthalmic center. Standard face-to-face interviews were conducted to ask about utility values (time trade-off and standard gamble for both death and blindness). Ocular information, including current visual acuity, intraocular pressure, visual field defect, and cup-disc ratio were also obtained. RESULTS: The mean time trade-off utility value was 0.88 (95% confidence interval 0.85, 0.91), and standard gamble for death and blindness were 0.94 (95% confidence interval 0.93, 0.96) and 0.95 (95% confidence interval 0.93, 0.97), respectively. Only 35.7% of patients were willing to trade time, and 34.3% willing to risk blindness in return for perfect vision. Both primary angle-closure glaucoma and primary open-angle glaucoma patients had similar utility values. After adjusting for age, gender, language spoken, educational level, and diagnosis, patients with better eye visual field PSD > 10 were 2.52 times (95% confidence interval 1.13, 5.61) more willing to trade time. In a multivariate model, the odds ratio of willingness to risk blindness for a complete hypothetical glaucoma cure was 9.88 (95% confidence interval 1.65, 59.23) for patients who had only visited an ophthalmologist 15 years or more ago, and 0.53 (95% confidence interval 0.27, 1.02) for patients who had previous trabeculectomy. CONCLUSION: Most Chinese glaucoma patients in Singapore are not willing to trade time or risk blindness. Patients with worse visual fields in the better-seeing eye are more willing to trade time; whereas patients who have not seen an ophthalmologist for at least 15 years or who had no history of a previous trabeculectomy are more willing to risk blindness.

Utility assessment among cataract surgery patients.

PURPOSE: To evaluate the utility values (time trade-off, standard gamble for death, standard gamble for blindness) of patients scheduled for cataract surgery. SETTING: Tertiary eye hospital in Singapore. METHODS: Questions on time trade-off, standard gamble for death, standard gamble for blindness utilities, and visual function from an adapted version of the VF-14 were asked in a clinic interview of 217 Chinese patients. RESULTS: The mean utility time trade-off of cataract surgery patients was 0.77 (95% confidence interval [CI] 0.76, 0.78), mean standard gamble for death was 0.77 (95% CI 0.77, 0.78), and mean standard gamble for blindness was 0.76 (95% CI 0.75, 0.77). Adults with lower VF-14 scores had lower utilities, although there was no relationship between visual acuity and utilities. Utilities were also lower in patients who reported difficulty seeing in bright light. CONCLUSIONS: The utilities of cataract patients scheduled for surgery were comparable to those in patients with other chronic ocular diseases. Cataract surgery patients with lower utilities tended to have worse visual function and greater difficulty seeing in bright light.