Cataract and glaucoma combined surgery: XEN® gel stent versus nonpenetrating deep sclerectomy, a pilot study.

BACKGROUND: To compare the efficacy of phacoemulsification (PKE) combined with nonpenetrating deep sclerectomy (NPDS) with mitomycin C (MMC) versus XEN® gel stent with MMC. METHODS: In this nonrandomized, retrospective, comparative, single-center pilot study, 105 consecutive eyes of 75 patients with uncontrolled primary open-angle glaucoma (POAG) and cataract who underwent PKE combined with either XEN implantation (n = 47) or NPDS (n = 58) between May 2013 and November 2018 were included. The primary outcome was complete success at 9 months, which was defined as intraocular pressure (IOP) ≤18, 15 or 12 mmHg without treatment; qualified success was IOP ≤18, 15 or 12 mmHg with antiglaucoma medications. Secondary outcome measures included the number of antiglaucoma medications, visual acuity (VA), and postoperative adverse events. RESULTS: Using the 18 mmHg threshold, complete or qualified success was achieved in 69.6 and 89.1% in the PKE + XEN group, and 63.8 and 89.7% in the PKE + NPDS group (p = .54 and p = .93), respectively, at 9 months. The mean IOP decreased from 20.8 ± 6.8 mmHg to 16.2 ± 2.8 mmHg in the PKE + XEN group (p < .001, 18.9% mean drop), and from 21.5 ± 8.9 mmHg to 14.9 ± 3.9 mmHg in the PKE + NPDS group (p < .001, 25.6% mean drop). Best-corrected VA significantly improved (p < .001) in both groups. The mean number of antiglaucoma medications was significantly reduced from 2.66 ± 1.1 to 0.49 ± 1.0 in the PKE + XEN group (p < .001) and from 2.93 ± 0.9 to 0.69 ± 1.2 in the PKE + NPDS group (p < .001). CONCLUSIONS: The XEN stent combined with PKE seemed to be as effective and safe as PKE + NPDS at 9 months in this pilot study.

Correction to: Central 10-degree visual field change following non-penetrating deep sclerectomy in severe and end-stage glaucoma: preliminary results.

The published online version contain mistake in the author list. The correct presentation is also given above.

Central 10-degree visual field change following non-penetrating deep sclerectomy in severe and end-stage glaucoma: preliminary results.

PURPOSE: To report the impact of non-penetrating deep sclerectomy (NPDS) in severe and end-stage glaucoma treatment on the central 10° visual field progression (mean deviation, four central points, foveal threshold) and assess the risk of sudden visual loss. METHODS: Monocenter database study. We reviewed records of 34 eyes with severe or end-stage glaucoma that underwent NPDS between 2009 and 2015, at the National Ophthalmology Center of XV-XX (Paris, France). Severe and end-stage glaucoma were defined according to the Bascom Palmer Modified Glaucoma Staging System classification. All eyes had a constricted visual field < 10° (severe injury by the Humphrey visual field automated (HVFA) 10-2). Visual fields were recorded every 6 months after the procedure. Data from the last visit was used for the statistical analysis. RESULTS: The mean follow-up duration was 29 months (range 6 to 54) and 33 (97%) eyes were followed for more than 1 year. There were no cases of postoperative sudden visual loss. The intraocular pressure (IOP) decreased from 21.9 ± 8.1 to 15.0 ± 5.4 mmHg (P < .001). Twenty-eight (82%) eyes had an IOP < 21 mmHg and 19 (56%) an IOP < 16 mmHg. The MD 10-2 remained stable (- 19.8 ± 7.4 to - 19.4 ± 8.1 dB, non-significant improvement of + 0.4 dB, P = .1). The MD 10-2 slope showed an insignificant improvement of + 0.25 ± 1.8 dB per year (dB/y) (P = 0.1), but this slope was significantly better when the IOP was reduced to < 16 mmHg than when the IOP was ≥ 16 mmHg at the last visit (+ 0.84  1.2 versus - 0.48 ± 2.2 dB/y, P = .05). The mean number of the four central test points with sensitivity ≤ 5 dB and the change in mean sensitivity of the four central field points remained stable. There were no significant changes in the VFI (from 25.4% ± 13 to 25.8% ± 20) and in foveal threshold. CONCLUSION: NPDS appears to provide stability of the central 10° visual field (with a trend towards improvement but non-significant) with no occurrence of "wipe-out" phenomenon and few other complications. Consideration of NPDS in end-stage and severe glaucoma is advisable given its low risk of complications and its considerable IOP decrease with a relative stability of the central visual field.

Decreased Corneal Sensation and Subbasal Nerve Density, and Thinned Corneal Epithelium as a Result of 360-Degree Laser Retinopexy.

PURPOSE: To assess the effects of 360-degree laser retinopexy on human corneal subbasal nerve plexus and to investigate correlations among corneal subbasal nerve plexus density, corneal epithelial thickness, and corneal sensitivity. DESIGN: Prospective, observational, nonrandomized study. PARTICIPANTS: A total of 15 eyes of 15 patients who underwent pars plana vitrectomy (PPV) with 360-degree laser retinopexy for retinal detachment (RD) and 15 eyes of 15 patients who underwent PPV for macular hole (MH) without laser treatment. METHODS: Corneal sensation, corneal epithelial thickness, and corneal subbasal nerve plexus density were assessed before surgery and 6 months after surgery via in vivo confocal microscopy, anterior segment optical coherence tomography (AS-OCT), and Cochet-Bonnet esthesiometry (Luneau Ophthalmologie, Paris, France). MAIN OUTCOME MEASURES: Corneal subbasal nerve plexus density, corneal epithelium thickness, and central corneal sensitivity. RESULTS: Compared with baselines values, the mean subbasal nerve density (P < 0.001), mean corneal epithelium thickness (P = 0.006), and mean corneal sensitivity (P < 0.001) in the RD group were significantly decreased 6 months after surgery by 74.3%, 4.7%, and 56.6%, respectively. Conversely, in the MH group there were no significant differences in the mean subbasal nerve density (P = 0.34), mean corneal epithelial thickness (P = 0.19), and mean corneal sensitivity (P = 0.42) between preoperative and 6-month postoperative values (0.7%, 0.4%, and 0.8%, respectively). The postoperative decrease in corneal subbasal nerve density after laser retinopexy was associated with a decrease in corneal epithelium thickness (r(2) = 0.42; P = 0.006) and a decrease in corneal sensitivity (r(2) = 0.48; P = 0.004). The postoperative decrease in corneal sensitivity poorly correlated with the decrease in corneal epithelial thickness (r(2) = 0.24; P = 0.045). Postoperative corneal nerve density decreased as total laser energy increased (r(2) = 0.51; P = 0.002). CONCLUSIONS: Subbasal corneal nerve plexus density decreases after 360-degree laser retinopexy and is accompanied by epithelium thinning and decreased corneal sensation. Surgeons should eschew heavy confluent retinal laser treatment, and corneal sensitivity should be assessed postoperatively to determine whether significant anesthesia has occurred. In such instances, prophylactic measures may be warranted against the development of neurotrophic ulcers.

Dexamethasone Implant under a Proactive Treatment Regimen in Clinical Setting: The ProDEX Study.

PURPOSE: To assess the effectiveness of switching intravitreal dexamethasone implants (DEX-implant) from pro re nata (PRN) treatment regimen to a proactive regimen in patients with macular edema of diverse etiologies. DESIGN: An observational, retrospective, uncontrolled, multicenter, national case series. PARTICIPANTS: Eighty-one eyes from 68 patients treated between October 2015 and June 2023 were included. METHODS: This study included consecutive eyes treated with DEX-implant who were switched from a PRN regimen to a proactive regimen for diabetic macular edema (DME), retinal vein occlusion (RVO), noninfectious uveitis macular edema (UME; including postsurgical macular edema), and radiation maculopathy (RM). MAIN OUTCOME MEASURES: The main outcome measures were change in the best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) at each visit. RESULTS: According to the etiology, DME represented 49.4% of eyes, UME 24.3%, RVO 21.0%, and RM 6.2%. The mean (standard deviation [SD]) duration of follow-up under the PRN and proactive regimens was 20.6 (13.3) and 14.2 (10.3) months, respectively. Switching from a PRN to a proactive regimen significantly improved mean (SD) BCVA by 3.7 (12.9) ETDRS letters (P = 0.01) with a mean (SD) decrease in CMT of 108.0 (151.4) µm (P < 0.001). The proportion of visits with significant anatomic recurrence (> 50 µm) also decreased from 40.1% to 6.0% after switching to a proactive regimen (P < 0.001). The number of DEX-implant injections significantly increased during the proactive treatment period (P < 0.001), but the change in the number of visits was not significantly different (P = 0.2). The proactive treatment period was not associated with a significant increase in IOP (P = 0.6). CONCLUSIONS: Switching to a proactive regimen in patients already treated with DEX-implant seems to significantly improve BCVA and CMT while maintaining stable IOP. FINANCIAL DISCLOSURES: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Comparison between air and gas as tamponade in 25-gauge pars plana vitrectomy for primary superior rhegmatogenous retinal detachment.

BACKGROUND/OBJECTIVES: The aim of this study was to compare surgical outcomes and postoperative characteristics, between eyes that underwent pars plana vitrectomy (PPV) for RRD, with air or different gas agents as tamponade. SUBJECTS/METHODS: The records of 262 patients that underwent PPV for RRD with air or different gas tamponades and a follow-up of at least 6 months were examined. Only cases with superior retinal breaks were included. Demographic, pre-, intra- and postoperative characteristics including rate of recurrence and complications were analysed. RESULTS: 48 patients were treated with air and 214 were treated with gas. No differences were found in success rate between air and gas group at both 3 and 6 months (respectively, 93.8% vs 93.6 and 100% vs 100%, all P values > 0.05). Postoperative best-corrected visual acuity (BCVA) was significantly higher in the air group compared with the gas group 7 days and 1 month postoperatively (respectively, 0.2 ± 0.4 vs 2.6 ± 0.5, P < 0.001 and 0.1 ± 0.4 vs 0.4±0.9, P = 0.04). The occurrence ocular hypertension at 1 month postoperatively was significantly higher in the gas group compared with the air group (15.4 % vs 0%, P < 0.001). At 6 months, the prevalence of epiretinal membrane (ERM) was significantly higher in the gas group compared with air group (4.2% vs 16.8%, P = 0.02). CONCLUSIONS: Air was comparable to gas tamponades in terms of surgical outcome and BCVA at 6 months. In addition, air allowed an earlier visual recovery and resulted in a lower rate of postoperative ocular hypertension and ERM.

Bilateral Traumatic Maculopathy after Closed-Globe Injury in Context of National Lockdown: A Case Report.

The aim of this study is to report a case of bilateral traumatic maculopathy in a 19-year-old male following blunt trauma during 2020 coronavirus disease-2019 national lockdown. Descriptive case report based on data from clinical records, patient observation, and analysis of diagnostic tests. A previously healthy, 19-year-old male presented for a visit in our department at 15-20 National Ophthalmology Institute with complaints of bilateral decreased visual acuity. A history of recent blunt trauma caused by resistance band was reported. Fundus examination recorded fibrosis and inferior preretinal hemorrhages on both eyes. Peripheral retinal examination was normal. Optical coherence tomography showed bilateral increased reflectivity, disruption of the inner/outer segment, and loss of the external limiting membrane. The 6-week follow-up did not show a major recovery. Early detection of posterior segment damage after blunt trauma remains primordial despite worldwide pandemic.

Visual Acuity Gain Profiles and Anatomical Prognosis Factors in Patients with Drug-Naive Diabetic Macular Edema Treated with Dexamethasone Implant: The NAVEDEX Study.

The purpose of this study is to evaluate the visual acuity (VA) gain profiles between patients with drug-naive diabetic macular edema (DME) treated by dexamethasone implant (DEX-implant) and assess the baseline anatomical and functional factors that could influence the response to the treatment in real-life conditions. A retrospective, multi-center observational study included 129 eyes with drug-naive DME treated by DEX-implant. The Median follow-up was 13 months. Two groups of VA gain trajectories were identified-Group A, with 71% (n = 96) of patients whose average VA gain was less than five letters and Group B, with 29% (n = 33) of patients with an average gain of 20 letters. The probability of belonging to Group B was significantly higher in patients with baseline VA < 37 letters (p = 0.001). Ellipsoid zone alterations (EZAs) or disorganization of retinal inner layers (DRILs) were associated with a lower final VA (53.0 letters versus 66.4, p = 0.002) but without a significant difference in VA gain (4.9 letters versus 6.8, p = 0.582). Despite a low baseline VA, this subgroup of patients tends to have greater visual gain, encouraging treatment with DEX-implant in such advanced-stage disease. However, some baseline anatomic parameters, such as the presence of EZAs or DRILs, negatively influenced final vision.

The Effect of Selective Laser Trabeculoplasty on Intraocular Pressure in Patients with Dexamethasone Intravitreal Implant-Induced Elevated Intraocular Pressure.

INTRODUCTION: To assess the safety and efficacy of selective laser trabeculoplasty (SLT) for ocular hypertension (OHT) induced by a dexamethasone (DEX) intravitreal implant. MATERIALS AND METHODS: We performed a retrospective study of patients who underwent an SLT procedure for ocular hypertension induced by injection of a DEX intravitreal implant. Patients had, at least, one injection of the DEX-implant for symptomatic macular edema. SLT was delivered to 360° of the trabecular meshwork in two sessions. The primary outcome was a decrease in IOP, evaluated at one, three, and six months after the SLT procedure. RESULTS: Twenty-six eyes of 22 patients were included. The mean intraocular pressure (IOP) measured after DEX-implant injection was 25.4 ± 5.4 mmHg, and the mean increase in IOP was 35.8 ± 14.6%. The mean follow-up after SLT was 18.3 ± 7.7 months. After SLT, the mean IOP dropped by 30.9% at one month (16.9 ± 4.5 mmHg, p=0.01), 33.6% at three months (16.0 ± 2.7 mmHg, p < 0.01), and 34.9% at six months (15.6 ± 2.1 mmHg, p < 0.01). Each patient had a minimum follow-up of 6 months after SLT. Eight eyes (31%) received a second DEX-implant injection after the SLT procedure without experiencing an increase in the IOP above 21 mmHg or >20%. No glaucoma surgery was required during the follow-up. The mean number of medications (1.65 ± 1.36) was significantly reduced at one (1.19 ± 1.20, p=0.04), three (0.96 ± 1.03, p < 0.01), and six months (0.77 ± 0.95, p < 0.01) after SLT. CONCLUSION: SLT is an effective and safe procedure to control OHT following DEX-implant intravitreal injection.

Outcomes of Laser Goniopuncture Following Nonpenetrating Deep Sclerectomy With Mitomycin C: A Large Retrospective Cohort Study.

PURPOSE: To report on the frequency, efficacy, and safety of laser goniopuncture (LGP) in lowering intraocular pressure (IOP) following mitomycin-C-augmented nonpenetrating deep sclerectomy (NPDS) in a large cohort of eyes. MATERIALS AND METHODS: This is a monocenter database retrospective study. We reviewed records of 350 eyes that underwent NPDS between 2009 and 2015, at the National Ophthalmology Center of XV-XX (Paris, France). We recorded the incidence of LGP, the time between NPDS and LGP, IOP efficacy, and the occurrence of complications. The success of the LGP was defined by an IOP<15 mm Hg without hypotonic treatment. RESULTS: The mean postoperative follow-up period was 19±15.9 months after the NPDS (range, 6 to 58). LGP was performed in 125 eyes (35.7%) in a mean time after NPDS of 7.4±7.6 months (range, 1 d to 36 mo). Most LGP procedures were performed during the first year (97 eyes, 77.6%). The survival analysis using the Kaplan-Meier method showed a 50% incidence of LGP by 2 years. The mean IOP before LGP was 23.8±7.1 mm Hg. LGP resulted in immediate (day 8) and significant IOP lowering by up to 15±6.8 mm Hg. This decrease was maintained throughout the follow-up period, and the Kaplan-Meier survival success rate at 2 years was 48.9% (95% confidence interval, 39.4-60.8). The most common complication was iris incarceration, which occurred in 22 eyes of 125 LGP (17.6%). CONCLUSIONS: Most of the eyes that underwent NPDS may require LGP to reduce the IOP to below the target value. Most often, this procedure was performed in the first year after NPDS (77.6%). LGP lowered IOP<15 mm Hg without any hypotonic medication for at least 2 years in 50% of cases. Goniopuncture is associated with potentially significant complications, of which the most common is iris incarceration. We identified 2 predicting factors for iris incarceration: high IOP before LGP and early LGP after NPDS.

Risk assessment of sudden visual loss following non-penetrating deep sclerectomy in severe and end-stage glaucoma.

BACKGROUND/OBJECTIVES: To assess the risk of immediate sudden visual loss ("wipe-out" phenomenon) following non-penetrating deep sclerectomy (NPDS) for end-stages glaucoma within the first 6-months postoperative period. SUBJECTS/METHODS: Monocenter database study. We reviewed the results for 73 eyes with severe or end-stage glaucoma that underwent NPDS. End-stage glaucoma (stage 5) was defined by the inability of patients to perform the Humphrey visual field test or by a visual acuity <20/200 due to glaucoma, according to the Glaucoma Staging System classification. Severe glaucoma (stage 4) was defined by a mean deviation (MD) <-20 dB by the preoperative 24-2 Humphrey visual field assessment. All eyes had a severe defect on the central 10° visual field: only a central island of vision remained. "Wipe-out" was defined as the permanent postoperative reduction of visual acuity to <20/200 or to "counting fingers" or less if preoperative visual acuity was <20/200. RESULTS: The mean age was 60 years (range 22-86). Before surgery, the average MD (Humphrey 24-2) was -25.6 ± 3.8 dB, the MD (Humphrey 10-2) -19.9 ± 7.0 dB, and the VFI 24.6 ± 13%. There were no cases of postoperative flat anterior chamber. No patients experienced "wipe-out" within the first 6 months following surgery. At the six-month visit, intraocular pressure (IOP) had decreased significantly from 22.0 ± 8.8 to 13.5 ± 4.5 mmHg (P<0.001). There were no significant changes in mean visual acuity after 6 months (P = 6). CONCLUSIONS: In our study, NPDS provided considerable IOP decrease with no occurrences of "wipe-out" and few other complications. Consideration of NPDS in end-stage and severe glaucoma is advisable given its low risk of intraoperative and postoperative complications and the low risk of wipe out. This surgery should probably be offered with less apprehension about the risk of "wipe-out" in end-stages glaucoma.

The Pattern of Recurrence in Diabetic Macular Edema Treated by Dexamethasone Implant: The PREDIAMEX Study.

PURPOSE: To assess the time to functional and anatomic recurrence of macular edema (ME) after a first intravitreal dexamethasone implant in eyes with diabetic macular edema (DME). DESIGN: A 6-month observational, prospective, uncontrolled, multicenter, national case series. PARTICIPANTS: Thirty-seven patients included between January 2015 and June 2016. METHODS: Patients were monitored at baseline and then monthly over 6 months after the first treatment. MAIN OUTCOME MEASURES: Different patterns of recurrence were defined: qualitative and quantitative anatomic recurrences and functional recurrence. RESULTS: Median ME duration before the first dexamethasone implant was 2.04 months. All patients received a dexamethasone implant for the first time, but 73% of patients had not undergone any form of treatment previously. The mean time from baseline to qualitative anatomic, quantitative anatomic, and functional recurrence was 4.22 months (95% confidence interval [CI], 3.80-4.65 months), 4.73 months (95% CI, 4.34-5.12 months), and 4.89 months (95% CI, 4.53-5.26 months), respectively. Almost all patients (7/8) who demonstrated a qualitative anatomic recurrence showed a subsequent quantitative anatomic and functional recurrence days later. Mean improvement in best-corrected visual acuity was 10.1 letters (95% CI, 6.7-13.4 letters) and 7.3 letters (95% CI, 4.1-10.6 letters) at months 2 and 6, respectively. The mean reduction in central subfield macular thickness was 206 µm (95% CI, 157-255 µm) and 146 µm (95% CI, 98-195 µm) at months 2 and 6, respectively. CONCLUSIONS: Dexamethasone implant is a functionally and anatomically effective treatment for DME in real-life practice. Qualitative anatomic recurrence seems to be an early sign of quantitative anatomic and functional recurrence. Further studies should demonstrate if early retreatment at the qualitative anatomic recurrence stage could better protect patient visual function.

Effectiveness and safety of dexamethasone implants for postsurgical macular oedema including Irvine-Gass syndrome: the EPISODIC-2 study.

AIM: To assess the effectiveness of intravitreal dexamethasone implants for treating postsurgical macular oedema (PSMO) including Irvine-Gass syndrome and determining the predictive factors of treatment response. METHODS: Descriptive, observational, retrospective, consecutive, uncontrolled, multicentre, national case series. One hundred patients were included between April 2011 and June 2014, with a minimum of 1-year follow-up. Patients received dexamethasone implant 0.7 mg at baseline. Clinical characteristics, best-corrected visual acuity (BCVA), central subfield macular thickness (CSMT) and intraocular pressure were measured at each visit. The main outcome measure was the change in BCVA (Early Treatment of Diabetic Retinopathy Study (ETDRS) letters: L). An analysis of predictive factors of treatment response is also provided. RESULTS: Mean improvement in BCVA was 9.6 (±10.6) L at month 6 and 10.3 (±10.7) L at month 12 (p<0.001). The proportion of eyes with gains in BCVA of 15 or more letters was 32.5% and 37.5% at months 6 and 12, respectively. The mean reduction in CSMT was 135.2 and 160.9 µm at months 6 and 12, respectively (p<0.001). Thirty-seven per cent of patients did not need a second injection after the first injection during follow-up. The presence of at least one PSMO risk factor decreases the probability of a gain in visual acuity (VA) ≥10 L (p=0.006). Initial VA ≤50 L at baseline and non-naïve status decrease the probability of having only one injection during follow-up (p=0.044). CONCLUSIONS: The significant gain in BCVA from baseline achieved at month 6 was maintained at month 12 after intravitreal injection of dexamethasone implant. Naïve status seems to be a good predictive factor of treatment response.

Three-year visual and anatomic results of administrating intravitreal bevacizumab in inflammatory ocular neovascularization.

OBJECTIVE: To assess the 3-year visual outcome of intravitreal bevacizumab in inflammatory ocular neovascularization. DESIGN: Experimental study. METHODS: Retrospective multicenter consecutive case series in 81 patients with inflammatory ocular neovascularization refractory to standard therapy and treated with intravitreal bevacizumab. The outcome measures included improvement of best corrected visual acuity expressed as logarithm of minimum angle of resolution (logMAR) and paired comparison decrease in central foveal thickness by optical coherence tomography. RESULTS: Mean best corrected visual acuity improved from baseline 0.699 (6/30 or 20/101) (SD 0.434) to 0.426 (6/16 or 20/53) (SD 0.428) (n = 81; p < 0.001), a gain of 2.7 lines (median 3 injections; 81 eyes; 81 patients). Paired comparisons revealed significant central foveal flattening at 3 years of 97.9 µm (n = 51; p < 0.001). In a subgroup analysis, visual improvement was significant for ocular histoplasmosis (p = 0.026); multifocal choroiditis (p = 0.05); serpiginous choroiditis (p = 0.028); ocular toxoplasmosis (p = 0.042); and punctate inner choroidopathy (p = 0.015). In a subgroup analysis, foveal flattening was significant for ocular histoplasmosis (p = 0.004); multifocal choroiditis (p = 0.007); serpiginous choroiditis (p = 0.011); and punctate inner choroidopathy (p = 0.001). Of the group, 5 eyes developed submacular fibrosis, 1 eye retinal pigment epithelial tear, and 1 eye macular ischemia in the context of vasculitis. CONCLUSION: At 3 years, intravitreal bevacizumab sustained significant visual improvement of 2.7 lines and significant foveal flattening of 98 µm in a wide variety of inflammatory ocular diseases without major complications after a median of 3 injections.