Additional Guidance on the Use of the PRESERFLO™ MicroShunt in the Treatment of Glaucoma: Insights from a Second Delphi Consensus Panel.

INTRODUCTION: The PRESERFLO™ MicroShunt (PMS) has been proven to significantly lower intraocular pressure (IOP) in patients with glaucoma and has been available for use since 2019. With increasing published evidence and growing experience of glaucoma surgeons, the aim of this modified Delphi panel was to build on the findings of a previous Delphi panel conducted in 2021 and provide further guidance on the role of the PMS to treat patients with glaucoma in Europe. METHODS: Thirteen European glaucoma surgeons experienced in the PMS procedure participated in a 3-round modified Delphi panel. A targeted literature review and expert steering committee guided Round 1 questionnaire development. Consensus was pre-defined at a threshold of ≥ 70% of panellists selecting 'strongly agree'/'agree' or 'strongly disagree'/'disagree' for 6-point Likert scale questions or ≥ 70% selecting the same option for multiple or single-choice questions. Questions not reaching consensus were restated/revised for the next round, following guidance from free-text responses/scoping questions. RESULTS: In total, 28% (n = 9/32), 52% (n = 16/31) and 91% (n = 10/11) of statements reached consensus in Rounds 1, 2 and 3, respectively. There was agreement that the PMS may be used in patients with pigmentary, post-trauma or post-vitrectomy glaucoma and for patients with uveitic glaucoma without active inflammation. The PMS may be more suitable for patients with contact lenses than other subconjunctival filtering surgeries, without eliminating bleb-associated risks. Consensus was reached that combining PMS implantation and phacoemulsification may be as safe as standalone PMS surgery, but further efficacy data are required. Following a late rise in IOP ≥ 4 months post-surgery, topical aqueous suppressant drops or bleb revision may be suitable management options. CONCLUSIONS: This Delphi panel builds on the considerations explored in the 2021 Delphi panel and provides further detailed guidance for glaucoma surgeons on the use of the PMS, reflecting the availability of novel evidence and surgical experience. Videos are available for this article.

The PRAMOS Study: PRostaglandin Analogues Monotherapy-Awareness Survey on Ocular Surface Involvement.

INTRODUCTION: Even though the local tolerance of prostaglandin (PG) analogues has improved drastically since the introduction of preservative-free (PF) eye drops, prescription patterns still vary widely among practitioners and between countries and could have an impact on the ocular surface of treated patients and, in consequence, their adherence. The aim of this study is to explore the prescribing patterns of PG analogues monotherapy in France and to evaluate their impact on ocular surface status. METHODS: This was a national multicenter cross-sectional observational study that was conducted by 18 glaucoma experts in France. Patients over 18 years of age and receiving monotherapy with topical PG analogues for the treatment of ocular hypertension and/or glaucoma, with no history of prior glaucoma surgery, were consecutively selected from the glaucoma outpatient clinics of participating physicians and underwent an ocular surface examination. RESULTS: A total of 344 eyes of 344 patients were enrolled between November 2022 and November 2023. Prescribed PG monotherapy was PF in 271 (78.7%) patients. Clinical history and ocular surface evaluation indicated that 79.4% of the study population (n = 273) presented with at least one symptom or clinical sign of dry eye and that three patients out of four had an unstable tear film. Subgroup analysis comparing preserved and PF PG analogues showed a higher prevalence of conjunctival hyperemia and corneal staining in the preserved group. Multivariate analysis identified conjunctival hyperemia as consistently associated with preservative use (odds ratio = 7.654; p = 0.003 for moderate conjunctival hyperemia). CONCLUSIONS: This study highlights the growing trend toward PF PG analogue prescriptions by specialists in France. However, ocular surface issues remain prevalent, impacting patient adherence and treatment efficacy. Comprehensive ocular surface examinations are crucial in glaucoma management to enhance long-term tolerance, compliance, and overall treatment success.

Expert Consensus on the Use of the PRESERFLO™ MicroShunt Device in the Treatment of Glaucoma: A Modified Delphi Panel.

INTRODUCTION: The implantation of the PRESERFLO™ MicroShunt (PMS) device has been shown to significantly lower increased intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG). However, guidelines on best practice for patient selection and pre-/peri-/postoperative care management are lacking. The aim of this modified Delphi panel was to achieve expert consensus on the role of the PMS to treat patients with glaucoma in Europe. METHODS: Twelve European glaucoma surgeons experienced with the PMS procedure participated in a three-round modified Delphi panel. A targeted literature review and expert steering committee guided round 1 questionnaire development. Consensus was set at a pre-defined threshold of at least 70% of panellists selecting 'Strongly disagree'/'Disagree' or 'Strongly agree'/'Agree' for six-point Likert scale questions, or at least 70% selecting the same option for multiple-choice questions. Questions not reaching consensus were restated/revised for the next round, following guidance from free-text responses/scoping questions. RESULTS: Consensus was achieved for 60.3% (n = 38/63), 60.0% (n = 18/30), and 100.0% (n = 11/11) of Likert/multiple-choice questions in rounds 1, 2, and 3, respectively. There was agreement that the PMS procedure is effective at reducing IOP in patients with high-tension POAG (greater than 21 mmHg). Although surgical techniques may vary slightly, consensus was reached on several points, including the importance of posterior application of mitomycin C (MMC). Panellists agreed that the PMS postoperative follow-up appointment schedule is reasonably predictable and mostly characterised by fewer visits than with trabeculectomy, particularly in the early phase. Although panellists agreed that combined cataract/PMS surgery and the use of non-MMC wound-healing modulators/antifibrotics during the procedure are possible, further data are needed to determine efficacy. CONCLUSION: The expert consensus reached in this panel will help inform best practice guidelines in the treatment of patients with glaucoma in Europe. Panellists also highlighted key areas for future research to improve understanding of the PMS in the treatment algorithm of glaucoma.

Safety and Effectiveness of the PRESERFLO® MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year Multicenter Study.

PURPOSE: To assess the safety and effectiveness of the PRESERFLO® MicroShunt (formerly InnFocus MicroShunt) in patients with primary open-angle glaucoma (POAG). DESIGN: The MicroShunt, a controlled ab externo glaucoma filtration surgery device, was investigated in a 2-year, multicenter, single-arm study. PARTICIPANTS: Eligible patients were aged 18-85 years with POAG inadequately controlled on maximal tolerated medical therapy with intraocular pressure (IOP) ≥18 and ≤35 mmHg or when glaucoma progression warranted surgery. METHODS: The MicroShunt was implanted as a stand-alone procedure with adjunctive use of topical mitomycin C (MMC; 0.2-0.4 mg/ml) for 2-3 minutes. MAIN OUTCOME MEASURES: The primary effectiveness outcome was IOP reduction and success (not requiring reoperation or pressure failures [IOP > 21 mmHg and < 20% reduction in IOP]) at year 1. Additional end points at year 2 included IOP reduction, success, glaucoma medications, adverse events (AEs), and reoperations. Results are reported in the overall population and subgroups of patients receiving 0.2 or 0.4 mg/ml MMC. RESULTS: In 81 patients, mean (± standard deviation [SD]) IOP decreased from 21.7 ± 3.4 mmHg at baseline to 14.5 ± 4.6 mmHg at year 1 and 14.1 ± 3.2 mmHg at year 2 (P < 0.0001). Overall success (with and without supplemental glaucoma medication use) at year 1 was 74.1%. Mean (± SD) number of medications decreased from 2.1 ± 1.3 at baseline to 0.5 ± 0.9 at year 2 (P < 0.0001), and 73.8% of patients were medication free. Most common nonserious AEs were increased IOP requiring medication or selective laser trabeculoplasty (25.9%) and mild-to-moderate keratitis (11.1%). There were 6 (7.4%) reoperations and 5 (6.2%) needlings by year 2. In an analysis (post hoc) according to MMC concentration, overall success was 78.1% (0.2 mg/ml) and 74.4% (0.4 mg/ml; P = 0.710). In the 0.2 and 0.4 mg/ml MMC groups, 51.9% and 90.3% of patients were medication free, respectively (P = 0.001). There was a trend toward lower IOP and higher medication reduction in the 0.4 mg/ml MMC subgroup. CONCLUSIONS: In this study, mean IOP and glaucoma medication reductions were significant and sustained over 2 years postsurgery. No long-term, sight-threatening AEs were reported. Further studies may confirm potential risk/benefits of higher MMC concentration.

National Health Care data system analysis of glaucoma surgery activity in France in 2016.

PURPOSE: To describe the glaucoma surgery offer in France in 2016. METHODS: We used the French National Health Care System database to identify all medical procedures carried out in 2016. The study investigated the entire population aged 30 years and older that had undergone glaucoma surgery, alone or combined with another surgery. We calculated the incidence of surgeries per 100 000 inhabitants 30 years of age and older performed by ophthalmologists carrying out at least 50 procedures annually, the number of surgeons doing these surgeries, the mean age of these practitioners, and the number of surgeons older than 55 years. RESULTS: In 2016, 16 854 glaucoma surgeries were performed in patients aged 30 years and older, for an incidence of 40.8 per 100 000 inhabitants aged 30 years and older. The most frequent procedure performed was trabeculectomy followed by non-penetrating deep sclerectomy (16.7 and 11.7, respectively, per 100 000 inhabitants 30 years of age and older). Private practice glaucoma surgery accounted for 47% of the activity of surgeons performing at least 50 surgeries per year and 60% of the total surgical activity. Of the private practice ophthalmologists performing at least 50 glaucoma surgery procedures per year, 58.5% were over 55 years of age, and 23.5% of public hospital ophthalmologists were over 55 years of age. CONCLUSIONS: This study demonstrates that surgeons performing glaucoma surgeries are often older. It is necessary to take note of the country's educational capacity to ensure that the number of ophthalmological surgeons remains adapted to demand.

Evaluation of 20-MHz high-frequency ultrasonography for the diagnosis of choroidal nevi.

PURPOSE: Evaluate short-term intraoperator reproducibility of ultrasonographic measurements of choroidal nevi using 10- and 20-MHz probes, and the efficacy of the high-frequency probes for the diagnosis of choroidal nevi. METHODS: Diameters and thicknesses of choroidal nevi were measured using a 10-MHz probe and a high-frequency long focal length 20-MHz probe (Quantel Medical™). The first part of the study evaluated intraoperator reproducibility of measurements of choroidal nevi with 10- and 20-MHz probes and the second part of the study allowed the comparisons of the measurements of largest tumor diameter (LDT) of choroidal nevi of 40 patients between the 10- and 20-MHz probes. The two-way random average agreement intraclass correlation coefficients (ICC), Bland-Altman plot, and a paired t test were used. RESULTS: The intraoperator reproducibility of choroidal nevi measurements with 10- and 20-MHz probes was excellent (ICC > 0.9, n = 20). Four flat nevi, not detectable at 10 MHz, could be located with the high-frequency probe (p = 0.12). There was no significant difference in thickness or LTD measurements between the 10- and 20-MHz probes (n = 31). Both techniques showed an excellent agreement (ICC > 0.8) for thickness and LTD measurements. All the choroidal nevi that were not measurable with the 10-MHz probe (n = 7) were measured with the 20-MHz probe. CONCLUSION: The high-frequency 20-MHz probe allows additional detection and measurements of flat choroidal nevi. When detectable, the ultrasonographic measurements of thickness and diameter of choroidal nevi are similar with both the 10- and the 20-MHz probes.

[New glaucoma surgery procedures]. / Nouvelles techniques de chirurgie du glaucome.

New glaucoma surgery procedures. The treatment of glaucoma aims to lower intraocular pressure in order to stop the evolution of the optic neuropathy. Surgery is indicated if medical and/or laser treatments are not sufficient and/or not well tolerated. The new minimally Invasive glaucoma surgery (migs) procedures allow faster visual recovery and reduce the risk of complications.

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MULTIFOCAL ELECTRORETINOGRAPHY AND SPECTRAL-DOMAIN OPTICAL COHERENCE TOMOGRAPHY IN MACULA-OFF RHEGMATOGENOUS RETINAL DETACHMENT: A Prospective Cohort Study.

PURPOSE: To analyze the temporal trends in structural changes using spectral-domain optical coherence tomography and functional changes using multifocal electroretinogram after rhegmatogenous retinal detachment surgery. METHODS: This prospective cohort study enrolled 69 patients with macula-off rhegmatogenous retinal detachment who underwent successful surgery. Early Treatment Diabetic Retinopathy Study visual acuity, multifocal electroretinogram evaluation of the central 5°, and spectral-domain optical coherence tomography were recorded at 1, 3, 6, and 12 months (M) after surgery. The fellow eye served as the control group for multifocal electroretinogram parameters. RESULTS: Between M1 and M12, visual acuity improved from 64 to 75 letters (P = 0.001) and implicit time of N1 decreased from 27.8 to 25.2 milliseconds (P = 0.001), whereas the other parameters did not vary significantly. Amplitude and implicit time values did not reach normal values at M12. Alterations of the ellipsoid zone and the external limiting membrane decreased over time (P = 0.001). P1 implicit time correlated independently with the alteration of the external limiting membrane (P = 0.007). CONCLUSION: Foveal wave amplitudes remain lower than normal values after successful surgery of rhegmatogenous retinal detachment, whereas anatomical improvement was found for outer retinal abnormalities and subretinal edema fluid. Retinal recovery improves N1 implicit time over time. Disruption of external limiting membrane seems to be predictive of increased P1 implicit time.

A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II).

PRECIS: In this European study (STAR-II), MINIject, a novel, ab-interno, supraciliary minimally invasive glaucoma surgery device, effectively lowered intraocular pressure (IOP) and the need for IOP-lowering medications in patients with primary open-angle glaucoma. PURPOSE: This study evaluates the safety and performance of a minimally invasive supraciliary glaucoma drainage device (MINIject DO627) for surgical treatment of primary open-angle glaucoma in patients refractory to topical hypotensive medications. METHODS: In a prospective, interventional, single-arm, multicenter, European study (STAR-II), MINIject was successfully implanted in a stand-alone procedure in 29 of 31 patients in 8 sites in 3 countries. The primary endpoint was the success rate 6 months after surgery >60% (defined as diurnal IOP ≤21 and >5 mm Hg with ≥20% IOP reduction from baseline, with/without glaucoma hypotensive medication). ClinicalTrials.gov: NCT03624361. RESULTS: At the 6-month follow-up, the primary endpoint was fulfilled, with 75.9% of patients reaching prospectively defined success. The mean IOP was reduced by 40.2% (9.9 mm Hg) to 14.7±6.0 mm Hg at 6 months from 24.6±3.8 mm Hg at baseline. The use of IOP-lowering medication ingredients was reduced by 63.4% from 2.9±1.2 at baseline to 1.0±1.3. Furthermore, 79.3% of the patients had mean IOP ≤18 mm Hg, 82.8% achieved a ≥20% IOP reduction, and 55.2% were medication free at 6 months. Six device-related serious adverse events were reported in the study eye: IOP increase (3/31 patients, 9.7%), and single reports of eye pain, corneal erosion, and chorioretinal folds (1/31, 3.2%), all of which resolved. There was minimal change to corneal endothelial cell density. CONCLUSION: Ab-interno supraciliary surgical implantation using MINIject DO627 in a stand-alone procedure significantly lowers IOP by 40% at the 6-month follow-up, while reducing the need for IOP-lowering medication.

Choroidal blood flow after the first intravitreal ranibizumab injection in neovascular age-related macular degeneration patients.

PURPOSE: To analyse choroidal blood flow (ChBF) changes after the first intravitreal ranibizumab injection in naïve, age-related macular degeneration (ARMD) patients. METHODS: Subfoveal ChBF was assessed by laser Doppler flowmetry (LDF) in newly diagnosed ARMD patients. Both treated and untreated eyes were assessed in each subject at each visit before the first intravitreal ranibizumab injection as well as 24 hr (day 1) and 7 days after (day 7). Central macular thickness (CMT), best-corrected visual acuity (BVCA), systemic haemodynamic parameters and LDF parameters were evaluated at each visit. Nonparametric tests were used to compare data between visits and between treated and untreated eyes. RESULTS: Seventeen ARMD patients were included (12 women and five men, 78 ± 8 years old). At day 7 postintravitreal ranibizumab injection, the normalized choroidal blood velocity (ChBVel) change in the treated eye group was significant (-10.2%; p = 0.006). The choroidal blood volume (ChBVol) did not change significantly after intravitreal injection of ranibizumab. There was a trend for a reduction in ChBF at day 7 (-9.1%, p = 0.08). The sensitivity of the experiment was 12% for ChBVel, 16% for ChBVol and 9% for ChBF. CONCLUSION: In conclusion, the laser Doppler technique provides feasible and noninvasive measurements of blood flow parameters before and after intravitreal injection of antivascular endothelial growth factor (anti-VEGF) in patients with exudative ARMD. Choroidal blood velocity decreased as early as 7 days after intravitreal ranibizumab injection, suggesting a vasoconstriction effect of anti-VEGF in large choroidal vessels in front of choriocapillaris (the site of LDF measurement).

High intensity focused ultrasound cyclocoagulation in dogs with primary glaucoma: a preliminary study.

The objective was to assess the effect of high intensity focused ultrasound (HIFU) on intraocular pressure (IOP) in dogs with primary glaucoma (PG). Seven dogs (13 eyes) presenting with PG as diagnosed by a raised IOP (> 20 mm Hg) associated with consistent gonioscopy and ultrasound biomicroscopy of the ciliary cleft, with no other ocular disease. Patients were divided into 3 groups, corresponding to their pre-operative IOP (group 1 ranging from 21 to 30 mm Hg, group 2 from 31 to 40 and group 3 for 40 and above). Ciliary process sonication was achieved with a probe containing one high-frequency transducer operating at 21 MHz during 5 seconds. Six sites were treated in patients from group 1, 8 in group 2, 10 in group 3, under general anesthesia. Post-operative treatment consisted of systemic meloxicam and topical carbonic anhydrase inhibitors, beta-blockers and prostaglandins analogues. No intraoperative complications were observed. Conjunctival hyperaemia occurred in eyes from group 2 (66%) and 3 (100%). Conjunctival burns were visible in 2 patients from group 3. One patient from group 3 experienced a hypertensive spike during the first hours post-op with associated pain. The hypotensive effect of HIFU was observed in all groups. Normotensive IOP (≤20 mm Hg) was reached in all patients until the last recheck at 6 months post op. Despite the small number of patients included in the study, HIFU appears to be a promising option for the management of PG in dogs.

Management of postoperative inflammation after cataract and complex ocular surgeries: a systematic review and Delphi survey.

Prevention and management of postoperative ocular inflammation with corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs) have been evaluated in several randomised controlled trials (RCTs). However, neither consensus regarding the efficacies of different regimens nor established guidelines are currently available. This has resulted in different practice patterns throughout the world. A systematic literature review found that for the management of postcataract inflammation nepafenac produced a positive outcome in three of three RCTs (3/3), as did ketorolac (1/1), bromfenac (7/7), loteprednol (3/3) and difluprednate (6/6), but not flurbiprofen (0/1). A single study found that betamethasone produced inconclusive results after retinal detachment (RD) surgery; ketorolac was effective (1/1) after vitrectomy, but triamcinolone was ineffective (0/1) after trabeculectomy. A two-round Delphi survey asked 28 international experts to rate both the inflammatory potential of different eye surgeries and their agreement with different treatment protocols. They rated trabeculectomy, RD surgery and combined phacovitrectomy as more inflammatory than cataract surgery. Vitrectomies for macular hole or epiretinal membrane were not deemed more inflammatory than cataract surgery. For trabeculectomy, they preferred to treat longer than for cataract surgery (NSAID + corticosteroid three times a day for 2 months vs 1 month). For vitrectomy alone, RD surgery and combined phacovitrectomy, the panel preferred the same treatment as for cataract surgery (NSAID + corticosteroid three times a day for 1 month). The discrepancy between preferred treatment and perception of the eye's inflammatory status by the experts for RD and combined vitreoretinal surgeries highlights the need for RCTs to establish treatment guidelines.

Change in Visual Field Progression Following Treatment Escalation in Primary Open-angle Glaucoma.

PURPOSE: To evaluate the effect of treatment escalation on the rate of visual field progression in patients with primary open-angle glaucoma (POAG). PATIENTS AND METHODS: Multicenter database study. We reviewed the electronic records of 171 patients with POAG under medical hypotensive treatment who underwent 5 consecutive visits 6 months apart before and after medical treatment escalation or additive laser trabeculoplasty. We calculated the rate of visual field progression (mean deviation change per year) before and after treatment escalation. RESULTS: The mean duration of follow-up was 5.1±0.5 years and the mean number of visual field examinations was 10.2±0.2. In 139 eyes with medical treatment escalation, the rate of progression was significantly reduced [from -0.57 to -0.29 dB/y; P=0.022; intraocular pressure (IOP) reduction 11.1%]. In detail, the rate of progression was significantly reduced after escalation from mono to dual therapy, dual to triple therapy, and from mono to triple therapy (-0.35 to -0.24 dB/y, P=0.018; -1.01 to -0.48 dB/y, P=0.038; -1.04 to -0.35 dB/y, P=0.020, respectively). In 32 eyes with additive laser trabeculoplasty, the rate of progression was significantly reduced (-0.60 to -0.24 dB/y; P=0.014; IOP reduction 9.4%). CONCLUSIONS: Medical treatment escalation or additive laser trabeculoplasty significantly reduced the rate of visual field progression in POAG. Larger IOP reduction has a greater probability of reducing glaucoma progression.

Longitudinal study of retinal status using optical coherence tomography after acute onset endophthalmitis following cataract surgery.

PURPOSE: To analyse the macula imaged with optical coherence tomography (OCT) in patients treated for acute postcataract endophthalmitis. METHODS: Patients presenting with acute postcataract endophthalmitis were included in this observational and multicentre study from January 2008 to December 2011. We recorded the following OCT data at the 3, 6 and 12-month visits: the central macular thickness, the perifoveal macular thickness, the central foveal point thickness and abnormalities of the outer retina, the macula and vitreoretinal interface. RESULTS: 46 patients were included in the OCT analysis. From month 3 to 12, epiretinal membrane (ERM) prevalence increased from 26% to 39%, vitreomacular traction prevalence decreased from 12% to 6%, non-tractional macular oedema (ME) prevalence varied between 7% and 13%. Only macular thinning remained stable at 10%. At month 12, a significant correlation was found between non-tractional ME and capsular rupture (at the time of cataract extraction, p=0.03). Eyes with an ERM exhibited increased central macular thickness (p=0.001) and lower visual acuity (VA) (p=0.02) at M12 in comparison to the group with normal macula. OCT analysis showed a significant association between ERM and the alteration of the ellipsoid band (p=0.02), as well as the external limiting membrane (ELM, p=0.07) at M12. CONCLUSIONS: ERM and ME were the main macular abnormalities diagnosed after 1 year of follow-up, associated with VA less than or equal to 20/40 in 50% of the cases. Ultrastructural abnormalities of the ELM and the ellipsoid band were frequently observed in those patients.

24-Hour Intraocular Pressure Rhythm in Patients With Untreated Primary Open Angle Glaucoma and Effects of Selective Laser Trabeculoplasty.

PURPOSE OF THE STUDY: The purpose of the study was to evaluate the 24-hour nyctohemeral rhythm of intraocular pressure (IOP) in patients with untreated primary open angle glaucoma using a contact lens sensor. To evaluate the effect of selective laser trabeculoplasty (SLT) on the 24-hour rhythm of IOP. MATERIALS AND METHODS: Prospective study conducted in a chronobiology center. Fourteen patients with primary open angle glaucoma underwent three 24-hour IOP measurement sessions after a complete wash-out of the medical treatment: before SLT and 1 and 6 months after, using the contact lens sensor Triggerfish (SENSIMED, Lausanne, Switzerland). IOP and the main parameters of nyctohemeral rhythm (existence of a rhythm, acrophase, bathyphase, midline estimating statistic of rhythm, amplitude, and range) before SLT were compared with the same parameters measured 1 and 6 months later. RESULTS: IOP increased from 16.3±3.7 to 22.1±8.4 mm Hg (5.8 mm Hg; 95% confidence interval (CI), 2.41-12.71; P=0.009) after the wash-out procedure. After SLT, IOP significantly decreased by 3.4 mm Hg (95% CI, 0.09-7.89; P=0.041) (14.9%) at 1 month and 1.9 mm Hg (95% CI 0.10-3.84; P=0.044) (8.1%) at 6 months. After medication wash-out, 100% of the subjects had a nyctohemeral IOP rhythm with nocturnal acrophase (01:57±3:32 AM, 01:22±3:01 AM, and 03:17±2:12 AM at inclusion, 1 and 6 mo, respectively). SLT did not significantly change the characteristics of the 24-hour IOP pattern, notably the amplitude and the type of rhythm (persistence of nocturnal acrophase). CONCLUSIONS: After medical treatment wash-out, patients with open angle glaucoma consistently had a significant 24-hour IOP rhythm with nocturnal acrophase. SLT reduces the absolute IOP value but does not modify the nyctohemeral IOP rhythm.

Postoperative Ocular Inflammation: A Single Subconjunctival Injection of XG-102 Compared to Dexamethasone Drops in a Randomized Trial.

PURPOSE: To evaluate the efficacy and safety of XG-102 (brimapitide) compared to dexamethasone eye drops in the treatment of postoperative ocular inflammation. DESIGN: Multicenter, randomized, parallel group, double-masked, noninferiority clinical trial. METHODS: Patients who underwent anterior and posterior segments combined surgery or glaucoma surgery or complex posterior segment surgery were eligible to participate. Patients were administered a single subconjunctival injection of 250 µL XG-102 90 µg (n = 47) or 900 µg (n = 48) or placebo (n = 50) at the end of ocular surgery. Subconjunctival injection for each group (XG-102 90 µg, XG-102 900 µg, or placebo) was followed by eye drops instilled 4 times per day for 21 days with placebo, placebo, or dexamethasone solution, respectively. The primary outcome measure was anterior chamber cell grades at day 28 comparing XG-102 900 µg with dexamethasone. RESULTS: The anterior cell grades for both XG-102 groups were noninferior to dexamethasone (-0.054 anterior cell grade [95% confidence interval -0.350-0.242]; P < .001 for noninferiority) for XG-102 900 µg and -0.086 anterior cell grade (95% confidence interval -0.214-0.385; P = .003 for noninferiority) for XG-102 90 µg. Rescue medication was introduced for 10 (21%), 7 (15%), and 2 (4%) patients allocated to the XG-102 90 µg, XG-102 900 µg, and dexamethasone groups, respectively. The difference between XG-102 90 µg and dexamethasone was statistically significant (P = .013). The number of patients for whom adverse events were reported and the nature of the events reported was similar between the 3 treatment groups. CONCLUSIONS: A single subconjunctival injection of XG-102 at the end of ocular surgery is noninferior to dexamethasone eye drops in the treatment of postoperative ocular inflammation.

Retinal Vein Occlusions: Therapeutic Switch in Macular Oedema Treatment with a 12-Month Follow-Up.

PURPOSE: To compare the visual and anatomical outcomes of patients with macular oedema secondary to retinal vein occlusion (RVO) after a switch from bevacizumab to intravitreal injection of a dexamethasone implant (IVI-DEX) or conversely. METHODS: 48 patients - 40 in the antivascular endothelial growth factor (VEGF) DEX sequence (AD group), 8 in the DEX anti-VEGF sequence (DA group) - were included in this multicentre retrospective study and evaluated at baseline, 1, 3, 6 and 12 months after the switch. The outcome measurements were visual acuity (VA) and central macular thickness (CMT) evaluated by spectral domain optical coherence tomography. Patients were defined as 'good responders' if CMT was ≤ 300 µm after the switch. RESULTS: VA significantly improved at 1 month in the AD group (p = 0.03) but not in the DA group (p = 0.40). CMT decreased significantly in the AD group at 1, 6 and 12 months (p = 0.002, p = 0.005 and p = 0.002, respectively). In the DA group, VA did not change from baseline at any time point, and CMT decreased at 1 month (p = 0.02) but not later on. CONCLUSIONS: In patients with macula oedema secondary to RVO, the switch from bevacizumab to IVI-DEX seems more beneficial in terms of short-term VA and long-term reduction of CMT than the DEX anti-VEGF agent sequence.

Occurrence and risk factors for retinal detachment after pars plana vitrectomy in acute postcataract bacterial endophthalmitis.

BACKGROUND/AIMS: To report the incidence, risk factors and prognosis of retinal detachment (RD) in patients who had vitrectomy for acute bacterial endophthalmitis after cataract surgery. METHODS: 123 patients with acute postcataract endophthalmitis, consecutively treated with pars plana vitrectomy (PPV) were included by the French Institutional Endophthalmitis Study group, in a prospective multicentre cohort study. Risk factors of RD were analysed using logistic regression. RESULTS: At the 6-month follow-up, the rate of post-PPV RD was 13% (n=16). The risk factors of post-PPV RD were diabetes (OR=4.7 (1.4-15.4), p=0.01) and visualisation of retinal vasculitis on the posterior pole (OR=3.8 (1.1-13.9), p=0.03) at the time of PPV. Postoperative RD occurred in 56% (n=9) of cases in the first month, in 31% (n=5) in the second month and in 6% (n=1) in the third month, with a mean delay of 47±71 days after PPV. The macula was detached in 12 cases (75%) and proliferative vitreoretinopathy grade C was present in seven cases. Final successful reattachment of the retina was obtained in 60% (n=9/15) of cases, with one (7/9) or two surgeries (2/9). Final visual acuity after surgical repair was ≥20/40 in 19% of cases, compared with 43% in patients without RD (p=0.05). CONCLUSIONS: RD is a major and severe complication of PPV performed in patients with acute postcataract endophthalmitis. Retinal vasculitis is a major risk factor of RD after PPV. Anatomical and functional outcome remain poor.

Multicenter clinical trial of high-intensity focused ultrasound treatment in glaucoma patients without previous filtering surgery.

PURPOSE: To evaluate the efficacy and safety of the ultrasonic circular cyclocoagulation procedure in patients with open-angle glaucoma naïve of previous filtering surgery. METHODS: Prospective non-comparative interventional clinical study conducted in five French University Hospitals. Thirty eyes of 30 patients with open-angle glaucoma, intra-ocular pressure (IOP) > 21 mmHg and with no previous filtering glaucoma surgeries were sonicated with a probe comprising six piezoelectric transducers. The six transducers were activated with a 6-s exposure time. Complete ophthalmic examinations were performed before the procedure and at 1 day, 1 week, 1, 2, 3, 6 and 12 months after the procedure. Primary outcomes were qualified surgical success (defined as IOP reduction from baseline ≥20% and IOP > 5 mmHg with possible re-intervention and without hypotensive medication adjunction) and complete surgical success (defined as IOP reduction from baseline ≥20%, IOP > 5 mmHg and IOP < 21 mmHg with possible re-intervention and without hypotensive medication adjunction) at the last follow-up visit and vision-threatening complications. Secondary outcomes were mean IOP at each follow-up visit compared with baseline, medication use, complications and re-interventions. RESULTS: Intra-ocular pressure was significantly reduced (p < 0.05) from a mean pre-operative value of 28.2 ± 7.2 mmHg (n = 3.6 hypotensive medications) to 19.6 ± 7.9 mmHg at 12 months (n = 3.1 hypotensive medications and n = 1.1 procedures) (mean IOP reduction of 30%). Qualified success was achieved in 63% of eyes (19/30) (mean IOP reduction of 37% in these eyes) and complete success in 46.7% of eyes (14/30) (mean IOP reduction of 37% in these eyes) at the last follow-up. No major intra- or post-operative complications occurred. CONCLUSIONS: The UC(3) procedure seems to be an effective and well-tolerated method to reduce IOP in patients with open-angle glaucoma without previous filtering surgery.