REAL WORLD STUDY COMPARING PHAKIC VERSUS PSEUDOPHAKIC EYES IN DIABETIC MACULAR EDEMA TREATED WITH DEXAMETHASONE IMPLANT: The PHAKIDEX Study.

PURPOSE: Dexamethasone implant (DEX-implant) is one treatment choice in diabetic macular edema. However, steroid-induced cataract is a common complication when treating a chronic disease and could lead to vision loss. Because of the lack of studies specifically focused on the functional outcomes according to the lens status, the authors therefore aim to analyze the effectiveness and safety of DEX-implant treatment for diabetic macular edema in phakic versus pseudophakic eyes. METHODS: This multicenter, retrospective study conducted in France included eyes of consecutive patients who had received a DEX-implant for diabetic macular edema. RESULTS: A total of 328 eyes were included: 158 eyes (48.2%) were phakic, 167 eyes (50.9%) were pseudophakic and three were unknown. According to the lens status, mean change in best-corrected visual acuity from baseline was never significantly different between phakic and pseudophakic eyes (likelihood ratio test, P = 0.09) nor in the change in central macular thickness (likelihood ratio test, P = 0.79) in multivariate analysis. Cataract surgery was performed in 63 phakic eyes (39.9%) during the study period with a mean delay of 8.1 months (CI95% [6.59-9.69]). The mean change in best-corrected visual acuity between phakic eyes who underwent cataract surgery and those who did not, was not significantly different during the follow-up at each visit. The risk of ocular hypertension was not statistically different between phakic and pseudophakic subsets ( P = 0.9). CONCLUSION: The authors showed here that phakic eyes treated with DEX-implant for diabetic macular edema did not have a significant difference in visual gain in comparison to pseudophakic eyes, with a comparable safety profile.

LONG-TERM INCIDENCE AND RISK FACTORS OF OCULAR HYPERTENSION FOLLOWING DEXAMETHASONE-IMPLANT INJECTIONS: THE SAFODEX-2 STUDY.

PURPOSE: To analyze the incidence, risk factors, and time to onset of ocular hypertension (OHT) after intravitreal injections (IVI) of dexamethasone implant and to evaluate the long-term cumulative probability of intraocular pressure elevation. METHODS: Eyes of patients having received at least one dexamethasone implant IVI between October 2010 and February 2015 were included in the present study. Ocular hypertension was defined as intraocular pressure > 25 mmHg and/or an increase of 10 mmHg over the follow-up period compared with baseline intraocular pressure. RESULTS: Four hundred ninety-four eyes were studied in 410 patients. For a total of 1,371 IVI, the incidence of OHT was 32.6% in the study eyes with a mean follow-up period of 30 months (3-62.5) and a median follow-up of 29 months. Pressure-lowering treatment was introduced for 36.9% of eyes. Topical treatment alone was sufficient to manage OHT in 97%. Young age, male sex, uveitis and retinal vein occlusion, and glaucoma treated with a double- or triple-combination topical pressure-lowering medication were found to be risk factors for OHT. The incidence of OHT did not change with an increase in the number of IVI, and there was no cumulative effect, defining by an increase of the incidence of OHT in patients after repeated IVI (P = 0.248). CONCLUSION: This study confirmed that OHT is of moderate incidence, transient, controlled by topical treatment and provides data on the long-term cumulative probability of intraocular pressure elevation in a large cohort of eyes treated with dexamethasone implant IVI. Repeat injections of dexamethasone implant neither increase nor decrease the risk of OHT.

XEN® 63 gel stent to treat a refractory uveitic glaucoma: A case report.

PURPOSE: To describe the effectiveness of the XEN® 63 gel stent in a refractory uveitic glaucoma after failure of an Ahmed Glaucoma Valve. CASE DESCRIPTION: We report the case of a 54-year-old man with a history of uveitic glaucoma on his left eye due to Fuchs heterochromic iridocyclitis and neovascular glaucoma after a central retinal vein occlusion. Pre-operative intraocular pressure was 30 mmHg despite a QD (once-daily) dosed bimatoprost 0.3 mg and timolol 5 mg topical medication. At week 1, the eye exam showed an intraocular pressure of 6 mmHg with a well-formed bleb, a very mild hyphema and a localized choroidal detachment. At month 1, intraocular pressure was 14 mmHg with a formed bleb. Both hyphema and choroidal detachments had resolved. After a year, intraocular pressure was 16 mmHg without any medication and the bleb was still well-formed. CONCLUSION: The XEN® 63 gel stent provides a good intraocular pressure reduction and can be an efficient alternative for tube and filtration surgery in refractory glaucoma. Its long-term effectiveness needs to be evaluated.

Relevance of Visual Acuity Measurement for Therapeutic Decisions in Age-Related Macular Degeneration.

The aim of this study is to assess if the decision to retreat could be determined by anatomical criteria (mostly driven by optical coherence tomography (OCT)-guided strategy) rather than the gold standard (visual acuity (VA) and OCT) in patients with neovascular age-related macular degeneration (nAMD). A cross-sectional study of 142 eyes already treated for nAMD from September 2021 to December 2021 was performed. At inclusion, a first therapeutic decision was made based on the analysis of the OCT. This decision was then maintained or modified after being made aware of the patient's VA. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated. The OCT-guided strategy matched the gold standard for treatment decisions in 131 of the 142 eyes included (92.3%). The sensitivity and specificity of the OCT-guided strategy for the retreatment decision were 94.0% and 89.8%, respectively. PPV and NPV were 92.9% and 91.4%, respectively. Considering the treatment regimen, eyes followed under the Pro ReNata regimen showed better sensitivity (100%) and specificity (93.3%) than eyes followed under the treat and extend regimen (93.5% and 88.6%, respectively). Based on the findings of this study, the follow-up for selected patients with nAMD under anti-VEGF treatment could be monitored without regular VA testing with acceptable performance.

Relevance of Visual Acuity Measurement for Therapeutic Decisions in Diabetic Macular Edema.

This study aimed to determine the validity of basing retreatment decisions on anatomical criteria alone (captured using optical coherence tomography (OCT)-OCT-guided strategy) rather than the gold standard (combined visual acuity (VA) and OCT) in patients with diabetic macular edema (DME). This cross-sectional study included 81 eyes undergoing treatment for DME from September 2021 to December 2021. An initial therapeutic treatment decision based on OCT results was made on inclusion. Subsequently, in light of the patient's VA score, this initial decision was upheld or adjusted, and the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated. In 67 out of the 81 eyes included in the study (82.7%), the OCT-guided strategy produced equivalent results to the gold standard. In this study, the OCT-guided retreatment decision strategy yielded sensitivity and specificity of 92.3% and 73.8%, respectively, and PPV and NPV of 76.6% and 91.2%, respectively. These findings differed according to the patient's treatment regimen: the sensitivity and specificity for eyes under a treat and extend regimen was higher, 100% and 88.9%, respectively, than eyes under a Pro Re Nata regimen, 90% and 69.7%, respectively. These findings show that VA testing could be omitted from the follow-up of certain patients with DME treated with intravitreal injections without impacting the quality of care.

Early Predictive Factors of Visual Loss at 1 Year in Neovascular Age-Related Macular Degeneration under Anti-Vascular Endothelial Growth Factor.

PURPOSE: To evaluate early predictive factors of visual loss in patients treated with anti-vascular endothelial growth factor (VEGF) injections under an as-needed regimen for neovascular age-related macular degeneration (AMD). DESIGN: Post hoc analysis from the randomized controlled trial Groupe d'Evaluation Français Avastin versus Lucentis (GEFAL). PARTICIPANTS: A total of 393 patients with neovascular AMD. METHODS: The present analysis is based on 1-year data from patients included in the study. Patients were separately categorized according to the best-corrected visual acuity (BCVA) change at 3 months and 1 year into 3 trajectories: (1) patients with no vision loss ≥5 letters at 3 months and 1 year (absence of loss ≥5 letters); (2) patients with no vision loss ≥5 letters at 3 months but loss ≥5 letters at 1 year (secondary loss ≥5 letters); and (3) patients with vision loss ≥5 letters at 3 months and 1 year (initial loss ≥5 letters). MAIN OUTCOME MEASURES: The following factors were evaluated at baseline and 3 months: age, sex, BCVA, presence of fluid, central macular thickness, angiographic choroidal neovascularization (CNV) subtype, CNV area measured in disc area on fluorescein angiography, and number of intravitreal injections. RESULTS: An absence of loss ≥5 letters was found in 225 patients (57.3%), a secondary loss ≥5 letters after 3 months was found in 109 patients (27.7%), and an initial loss ≥5 letters was found in 59 patients (15%). Baseline characteristics were comparable among the 3 groups except for the total CNV area, which was larger in the initial and secondary loss groups (P = 0.0412). At 3 months, a significant association was found between presence of subretinal fluid (SRF) (P = 0.0318) and vision loss ≥5 letters, and an even stronger significant association between the presence of intraretinal fluid (IRF) (P = 0.0066) and vision loss ≥5 letters. CONCLUSIONS: In the present study, we found that a large CNV area at baseline was significantly associated with initial or secondary loss of visual acuity ≥5 letters despite anti-VEGF injection. The presence of fluid, both SRF and IRF, at 3 months was found in patients with poorer trajectories.

Unexpected amaurosis occurring after peribulbar anesthesia: Exploring the causes in two cases.

Peribulbar anesthesia (PB) is known to be safer than retrobulbar (RB) anesthesia. To our knowledge, no amaurosis has been described after PB. We report here the cases of two patients who underwent PB before membrane peeling. The injections were administered with a 25-gauge, 22-mm bevel disposable needle. The anesthetic used was ropivacaine 1% with a volume of 8 ml and 75 µg of clonidine as an adjuvant (7.5 µg/ml). Given that complete akinesia was not achieved, a second injection of 2 ml was administered in the supero-medial injection site. Thirty minutes after the PB, the first patient experienced amaurosis with no light perception (LP). The ophthalmic examination was normal. Visual acuity recovered after 1 day. Regarding the second patient, the loss of VA was observed 20 min after the PB. IOP was 20 mmHg. The anterior segment and fundus exam were normal. Rubin found the PB technique to be as effective and safer than RB injection, as the needles are not supposed to enter the RB space and Davis and Mandel found no amaurosis after PB. PB is administered via the extraconal injection of an anesthetic agent. These amaurosis might be explained by the fact that some anesthetic may have penetrated the RB space. In cases where two PB injections are administered, the anatomy is expected to change due to the volume effect of the first injection. The second injection is higher risk as it is administered closer to the optic nerve.

Evaluation of the Correlation between Regional Retinal Ganglion Cell Damage and Visual Field Sensitivity in Patients with Advanced Glaucoma.

(1) Background: to investigate the correlation between structural (retinal ganglion cells and retinal nerve fibers) and functional alterations analyzed point-by-point in the central 10 degrees of the visual field of patients with advanced glaucoma using Humphrey 10-2 visual field tests. (2) Methods: Single-center prospective cohort study carried on from October 2018 to February 2019 at the Croix-Rousse hospital, Lyon, France. The primary outcome measure was the point-by-point correlation between retinal sensitivity (Humphrey 10-2) and retinal ganglion cell complex (GCC) thickness. (3) Results: 29 eyes of 27 patients were examined. Of these, 15 eyes had a mean deviation (MD) less than −20 dB. There were statistically significant linear relationships between GCC thickness and 10-2 visual field sensitivity for several points in the lower part of the visual field, with lower retinal sensitivity being associated with thicker GCC layers. There were no strong linear relationships or statistically significant correlations in the other regions of the visual field. For the patients with MD < −20 dB, there were statistically significant linear relationships between GCC thickness and 10-2 visual field sensitivity for several points in the superior nasal region. Retinal sensitivity was not correlated with retinal nerve fibre layer thickness. (4) Conclusions: In this study of patients with advanced glaucoma, GCC thickness was linearly associated with 10-2 visual field sensitivity in certain regions, negatively for patients with less-severe glaucoma. The initial thickening raises questions about the apoptosis mechanism, while the thinning observed in the most severe cases is consistent with the ganglion cell death identified on visual field tests.

Preserflo Microshunt Surgery for Ocular Hypertension following Intravitreal Fluocinolone Acetonide Implant Removal: A Case Report.

Diabetic macular edema (DME) is now a well-known condition for which a number of treatments have been shown to be effective. Intraocular corticosteroids are part of this therapeutic arsenal but are sometimes responsible for ocular hypertension. We describe here the case of a 60-year-old man with a history of bilateral DME who received an intravitreal injection of 190 µg fluocinolone acetonide (FAc) (ILUVIEN®, Alimera Sciences, Alpharetta, GA, USA) who presented a persistent ocular hypertension in one eye despite FAc removal by pars plana vitrectomy and was successfully managed by Preserflo® microshunt surgery.

Efficacy and Safety of Intravitreal Fluocinolone Acetonide Implant for Chronic Diabetic Macular Edema Previously Treated in Real-Life Practice: The REALFAc Study.

Diabetic macular edema (DME) is the main cause of visual impairment in diabetic patients and a chronic disease requiring long-term treatments. The fluocinolone acetonide (FAc) implant has recently been approved to treat DME in patients considered insufficiently responsive to available therapies. This study evaluates the functional and anatomical efficacy of the FAc implant in real-life practice. A total of 62 eyes with chronic DME were included and followed for a mean of 13.9 (+7.5) months. Previous treatment included at least anti-vascular endothelial growth factor (VEGF) in 83.9% of eyes, dexamethasone implant (DEX-I) in 100% of eyes, vitrectomy in 29.0% of eyes, and laser photocoagulation (either panretinal or focal photocoagulation) in 75.8% of eyes. The mean baseline best corrected visual acuity (BCVA) was 64.0 (+/−17.2) letters (median: 67.5 letters) with a mean DME duration of 60.3 (+/−30.6) months. The maximum BCVA gain occurred at 21 months with a mean gain of 5.0 (+/−12.7) letters. A total of 50.0% of eyes gained ≥5 letters during follow-up. Patients with lower BCVA at baseline had the lowest final BCVA (p < 0.001) but the highest BCVA gain (p = 0.02). The best overall improvement in mean central macular thickness (CMT) occurred at 18 months (p < 0.0001). The improvement in BCVA was inversely associated with the decrease in CMT and showed a decrease when CMT increased (DME recurrence). According to the history of vitrectomy, we did not find any significant difference in mean final BCVA (p = 0.1) and mean BCVA gain (p = 0.2) between eyes previously vitrectomized or not. A total of 23 eyes (37.1%) required additional treatment for DME, and 17.7% required an IOP-lowering procedure during follow-up. In conclusion, this real-life observational study demonstrated the efficacy and safety of the FAc implant in patients with chronic DME already treated with other available therapies.

Intra-Ocular Pressure Response to Dexamethasone Implant Injections in Patients with a History of Filtering Surgery: The TRABEX Study.

Patients with both macular edemas, of various etiologies such as diabetes and glaucoma, may suffer serious loss of vision if either disease goes untreated. Where no effective alternative therapies are available, dexamethasone implant (DEX-I) injections may be the only choice of treatment, despite the risk of a possible increase in intraocular pressure (IOP) when using steroids. Although many studies have reported on IOP evolution in eyes treated with DEX-I, little is known specifically about eyes with a history of filtering surgery. The aim of this observational series was to evaluate the IOP response following DEX-I injection in eyes presenting conventional filtering surgeries or microinvasive glaucoma surgeries (MIGS). Twenty-five eyes were included in this study. A total of 64% of the eyes did not experience OHT during follow-up. Additional IOP-lowering therapy was needed for 32% of eyes, and 20% of eyes (all showing bleb fibrosis) required further filtering surgery: 50% of eyes in the MIGS group and 10.5% of eyes in the conventional filtering surgery group. A significant positive correlation was found between IOP at baseline and the maximum IOP throughout follow-ups after DEX-I (r = 0.45, p = 0.02). In conclusion, if DEX-I is used when there are no alternative therapies for treating macular edema, IOP in eyes with a history of filtering surgery is generally manageable. Those eyes which previously underwent conventional therapy with effective blebs obtained better IOP control after DEX-I injections and mostly did not require any additional IOP-lowering therapy or surgery.

XEN Gel Stent to Treat Intraocular Hypertension After Dexamethasone-Implant Intravitreal Injections: 5 Cases.

INTRODUCTION: Intravitreal injections (IVI) of slow-release dexamethasone (DEX) are generally well tolerated. Ocular hypertension (OHT) and cataracts are the most common adverse effects of DEX-implant (DEX-I). MATERIAL AND METHODS: The cases reported concern 5 eyes in four DEX-I IVI high-responder patients whose intraocular pressure (IOP) returned to normal after administration of a XEN gel stent with mitomycin subconjunctival injection, thus allowing the continued use of DEX-I which was the only therapeutic option for these patients. All patients were pure steroid responders with normal optic nerves. RESULTS: No hypertension was observed in any of the eyes after DEX-implant intravitreal reinjection following XEN-surgery.All patients were successfully treated with XEN surgery and were retreated with DEX-implant with no further increase in IOP. The mean duration of follow-up after the MIGS procedure was 5 months (min-max, 2-12). None of the patients required needling. CONCLUSIONS: XEN gel stent would seem to represent a safe and effective solution for treating steroid-induced hypertension. It allows for the medium and long-term use of DEX-I in high responders. It could be of clinical interest to study this combination in a prospective trial with a large number of patients and long-term follow-up.

Hypertensive choroidopathy: Multimodal imaging and the contribution of wide-field swept-source oct-angiography.

PURPOSE: To present the case of a patient with a hypertensive choroidopathy and her follow-up using multimodal imaging; and to assess how wide-field swept-source (SS) Optical Coherence Tomography Angiography (OCTA) contributes to detecting the areas of hypoperfusion. OBSERVATIONS: A 25-year-old white woman with terminal renal insufficiency, myopericarditis, and cerebrospinal fluid pressure of 37 mmHg indicating intracranial hypertension, presented with a painless loss of vision in both eyes. Her blood pressure was 190/135 mmHg. A thorough diagnosis work-up failed to reveal the etiology. The fundus examination showed arterial narrowing and moderate venous dilation in both eyes. Deep yellow spots were found bilaterally, associated with slight pigment epithelium detachments and exudative retinal detachments. Multimodal imaging showed characteristic features of choroidal involvement in hypertension. Wide-field 12 × 12 mm PlexElite map montage at the choriocapillaris slab identified areas of non-perfusion of the choriocapillaris. These areas mostly correlate with late indocyanine green angiography (ICGA)-presumed choroidal ischemia. During the follow-up, the patient's blood pressure normalized and the choriocapillaris flow improved. CONCLUSIONS AND IMPORTANCE: In this case of malignant hypertensive retinopathy with exudative retinal detachment of the posterior pole, SS-OCTA showed multiple and widespread flow voids on the choriocapillaris slabs, corresponding to the areas of hypofluorecence on ICGA, demonstrating an associated hypertensive choroidopathy. It would appear that SS-OCTA used alone is capable to show choroidal vascularization impairment in cases of hypertensive retinopathy.

Evaluation of Efficacy and Safety of Dexamethasone Intravitreal Implants of Vitrectomized and Nonvitrectomized Eyes in a Real-World Study.

PURPOSE: To compare the efficacy and safety of the dexamethasone (DEX) intravitreal implant of vitrectomized and nonvitrectomized eyes in real-world conditions. METHODS: This was a retrospective, multicenter, observational study. All consecutive patients presenting with at least one 0.7-mg intravitreal injection of DEX implant were included in this study. A total of 186 eyes in 170 patients were analyzed. Fifty-nine eyes were vitrectomized at baseline and 127 eyes had no vitrectomy at the last visit. Among the baseline-vitrectomized eyes analyzed, 72.9% were treatment naive eyes, and 44.1% of nonvitrectomized eyes had no prior treatment. RESULTS: There was no statistically significant difference in the variation in best-corrected visual acuity (BCVA) between the 2 groups (P = 0.343). Variations of BCVA and central macular thickness were not significantly different between nonvitrectomized eyes and baseline-vitrectomized eyes. The intraocular pressure profile was the same in both nonvitrectomized eyes and baseline-vitrectomized eyes. The mean interval between injections was 6.9 months (2; 27.7) for nonvitrectomized eyes and 5.2 months (4; 22.1) for baseline-vitrectomized eyes (P = 0.001). The mean number of IVIs was 2 (1; 6) for nonvitrectomized eyes and 2.3 (1; 10) for baseline-vitrectomized eyes (P = 0.188) during the total follow-up period. CONCLUSION: This large cohort shows that vitrectomy does not seem to influence the efficacy and safety profile of dexamethasone intravitreal implant for DME.