PTVR - A software in Python to make virtual reality experiments easier to build and more reproducible.

Researchers increasingly use virtual reality (VR) to perform behavioral experiments, especially in vision science. These experiments are usually programmed directly in so-called game engines that are extremely powerful. However, this process is tricky and time-consuming as it requires solid knowledge of game engines. Consequently, the anticipated prohibitive effort discourages many researchers who want to engage in VR. This paper introduces the Perception Toolbox for Virtual Reality (PTVR) library, allowing visual perception studies in VR to be created using high-level Python script programming. A crucial consequence of using a script is that an experiment can be described by a single, easy-to-read piece of code, thus improving VR studies' transparency, reproducibility, and reusability. We built our library upon a seminal open-source library released in 2018 that we have considerably developed since then. This paper aims to provide a comprehensive overview of the PTVR software for the first time. We introduce the main objects and features of PTVR and some general concepts related to the three-dimensional (3D) world. This new library should dramatically reduce the difficulty of programming experiments in VR and elicit a whole new set of visual perception studies with high ecological validity.

Untargeted Multiomics Approach Coupling Lipidomics and Metabolomics Profiling Reveals New Insights in Diabetic Retinopathy.

Diabetic retinopathy (DR) is a microvascular complication of diabetes mellitus (DM) which is the main cause of vision loss in the working-age population. Currently known risk factors such as age, disease duration, and hemoglobin A1c lack sufficient efficiency to distinguish patients with early stages of DR. A total of 194 plasma samples were collected from patients with type 2 DM and DR (moderate to proliferative (PDR) or control (no or mild DR) matched for age, gender, diabetes duration, HbA1c, and hypertension. Untargeted lipidomic and metabolomic approaches were performed. Partial-least square methods were used to analyze the datasets. Levels of 69 metabolites and 85 lipid species were found to be significantly different in the plasma of DR patients versus controls. Metabolite set enrichment analysis indicated that pathways such as metabolism of branched-chain amino acids (methylglutaryl carnitine p = 0.004), the kynurenine pathway (tryptophan p < 0.001), and microbiota metabolism (p-Cresol sulfate p = 0.004) were among the most enriched deregulated pathways in the DR group. Moreover, Glucose-6-phosphate (p = 0.001) and N-methyl-glutamate (p < 0.001) were upregulated in DR. Subgroup analyses identified a specific signature associated with PDR, macular oedema, and DR associated with chronic kidney disease. Phosphatidylcholines (PCs) were dysregulated, with an increase of alkyl-PCs (PC O-42:5 p < 0.001) in DR, while non-ether PCs (PC 14:0-16:1, p < 0.001; PC 18:2-14:0, p < 0.001) were decreased in the DR group. Through an unbiased multiomics approach, we identified metabolites and lipid species that interestingly discriminate patients with or without DR. These features could be a research basis to identify new potential plasma biomarkers to promote 3P medicine.

A retrospective, multicenter study on the management of macular holes without residual internal limiting membrane: the refractory macular hole (ReMaHo) study.

PURPOSE: To evaluate the surgical management, outcomes and prognostic factors of full thickness macular holes without residual internal limiting membrane (NO-ILM FTMHs). METHODS: We performed a multicenter, retrospective study of 116 NO-ILM FTMHs. Human amniotic membrane (hAM) plug, autologous ILM free flap transplantation (AILMT), and autologous retinal graft transplantation (ART) were performed in 58, 48, and 10 patients, respectively. Data were collected before and up to 12 months after surgery. The primary outcomes were hole closure and final best-corrected visual acuity (BCVA). RESULTS: The final BCVA (0.78 ± 0.51 logMAR) was significantly better than and correlated with the initial BCVA (p < 0.0001 and p = 0.004, respectively). Hole closure was achieved in 92% of eyes. The minimum FTMH diameter was wider and final BCVA was lower in the ART group than in the other groups (p < 0.003 and p < 0.001, respectively). FTMHs with diameter > 680 µm had a higher closure rate with hAM than with AILMT (p = 0.02). CONCLUSIONS: AILMT and hAM were the most frequently performed surgeries with both high closure rate and significant functional improvement. Preoperative BCVA was correlated with final BCVA. The minimum FTMH diameter may guide the treatment choice.

IMPACT OF FLUID COMPARTMENTS ON FUNCTIONAL OUTCOMES FOR PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Systematic Literature Review.

PURPOSE: Understanding the impact of fluid in different retinal compartments is critical to developing treatment paradigms that optimize visual acuity and reduce treatment burden in neovascular age-related macular degeneration. This systematic review aimed to determine the impact of persistent/new subretinal fluid, intraretinal fluid, and subretinal pigment epithelial fluid on visual acuity over 1 year of treatment. METHODS: Publication eligibility and data extraction were conducted according to Cochrane methods: 27 of the 1,797 screened records were eligible. RESULTS: Intraretinal fluid negatively affected visual acuity at baseline and throughout treatment, with foveal intraretinal fluid associated with lower visual acuity than extrafoveal intraretinal fluid. Some studies found that subretinal fluid (particularly subfoveal) was associated with higher visual acuity at Year 1 and longer term, and others suggested subretinal fluid did not affect visual acuity at Years 1 and 2. Data on the effects of subretinal pigment epithelial fluid were scarce, and consensus was not reached. Few studies reported numbers of injections associated with fluid status. CONCLUSION: To optimally manage neovascular age-related macular degeneration, clinicians should understand the impact of fluid compartments on visual acuity. After initial treatment, antivascular endothelial growth factor regimens that tolerate stable subretinal fluid (if visual acuity is stable/improved) but not intraretinal fluid may enable patients to achieve their best possible visual acuity. Confirmatory studies are required to validate these findings.

RECURRENCES OF RETINAL DETACHMENT AFTER RETINECTOMY: Causes and Outcomes.

PURPOSE: To evaluate the different mechanisms of retinal detachment recurrence after retinectomy for rhegmatogenous retinal detachment (RD) complicated by proliferative vitreoretinopathy (PVR) and to study its outcome and prognosis. METHODS: Retrospective, multicenter study conducted between January 2009 and November 2016. Retrospective review of 56 patients with recurrent RD (RRD) after a first relaxing retinectomy. RESULTS: The secondary retinal attachment rate was 58.9% (33/56 cases). The various mechanisms of RRD were mainly related to PVR (52/56 cases: 93%). This PVR was anterior in 10 cases (21%), posterior in 31 cases (60%), and combined anterior and posterior in 11 cases (21%). The RRD mechanism was not PVR in 4 of the 56 cases. Some of the RRD mechanisms were specific to retinectomy: fibrosis of the edge of the retinectomy (26 cases: 46.4%), beyond-the-edge proliferation (8 cases: 14.3%), and severe inferior retinal folding (2 cases: 3.6%). In the 2 cases of severe inferior retinal folding, the retina could not be reattached. The anatomical outcome and the mechanism of RRD (anterior PVR, posterior PVR, or combined anterior and posterior PVR) were not correlated (P = 0.12). Visual acuity was significantly better only in patients with complete secondary success, that is, having an attached retina after silicone oil removal: mean preoperative visual acuity was 2.01 logarithm of the minimum angle of resolution versus 1.01 logarithm of the minimum angle of resolution postoperatively (P = 0.019). CONCLUSION: Proliferative vitreoretinopathy caused most of the recurrences, and the anatomical outcome did not depend on the type of PVR involved. Only complete secondary success (attached retina after silicone oil removal) was accompanied by visual acuity improvement.

Contribution of Short-Time Occlusion of the Amblyopic Eye to a Passive Dichoptic Video Treatment for Amblyopia beyond the Critical Period.

Dichoptic movie viewing has been shown to significantly improve visual acuity in amblyopia in children. Moreover, short-term occlusion of the amblyopic eye can transiently increase its contribution to binocular fusion in adults. In this study, we first asked whether dichoptic movie viewing could improve the visual function of amblyopic subjects beyond the critical period. Secondly, we tested if this effect could be enhanced by short-term monocular occlusion of the amblyopic eye. 17 subjects presenting stable functional amblyopia participated in this study. 10 subjects followed 6 sessions of 1.5 hour of dichoptic movie viewing (nonpatched group), and 7 subjects, prior to each of these sessions, had to wear an occluding patch over the amblyopic eye for two hours (patched group). Best-corrected visual acuity, monocular contrast sensitivity, interocular balance, and stereoacuity were measured before and after the training. For the nonpatched group, mean amblyopic eye visual acuity significantly improved from 0.54 to 0.46 logMAR (p < 0.05). For the patched group, mean amblyopic eye visual acuity significantly improved from 0.62 to 0.43 logMAR (p < 0.05). Stereoacuity improved significantly when the data of both groups were combined. No significant improvement was observed for the other visual functions tested. Our training procedure combines modern video technologies and recent fundamental findings in human plasticity: (i) long-term plasticity induced by dichoptic movie viewing and (ii) short-term adaptation induced by temporary monocular occlusion. This passive dichoptic movie training approach is shown to significantly improve visual acuity of subjects beyond the critical period. The addition of a short-term monocular occlusion to the dichoptic training shows promising trends but was not significant for the sample size used here. The passive movie approach combined with interocular contrast balancing even over such a short period as 2 weeks has potential as a clinical therapy to treat amblyopia in older children and adults.

Decompression retinopathy following nonpenetrating deep sclerectomy for primary congenital glaucoma.

BACKGROUND: To describe a unique case of decompression retinopathy manifesting as pre-macular subhyaloid hemorrhage that occurs in a nine-day old child after undergoing a non-penetrating deep sclerectomy for primary congenital glaucoma. CASE PRESENTATION: We report a single case of a 9-day-old boy who was referred to our department of ophthalmology for bilateral buphtalmia and corneal edema. He presented marked elevation of the intraocular pressure in both eyes (22 mmHg and 26 mmHg, in the right eye and left eye respectively) associated with significant optic nerve cupping. Non-penetrating deep sclerectomy was performed for each eye, with effective reduction of the intraocular pressure during the first week postoperatively (11 mmHg and 7 mmHg in the right eye and left eye respectively). The right eye presented an isolated subhyaloid hemorrhage located in the pre-macular area, persisting 3 weeks after the initial surgery and requiring pars-plana vitrectomy to clear the visual axis. This uncommon complication was identified as decompression retinopathy. The intraocular pressure remained controlled in the normal range three years after initial surgery in both eyes, with reversal of optic disc cupping. CONCLUSIONS: Decompression retinopathy is a potential complication after non-penetrating deep sclerectomy in primary congenital glaucoma, requiring prompt treatment strategy to prevent potential organic amblyopia.

A Vision Enhancement System to Improve Face Recognition with Central Vision Loss.

SIGNIFICANCE: The overall goal of this work is to validate a low vision aid system that uses gaze as a pointing tool and provides smart magnification. We conclude that smart visual enhancement techniques as well as gaze contingency should improve the efficiency of assistive technology for the visually impaired. PURPOSE: A low vision aid, using gaze-contingent visual enhancement and primarily intended to help reading with central vision loss, was recently designed and tested with simulated scotoma. Here, we present a validation of this system for face recognition in age-related macular degeneration patients. METHODS: Twelve individuals with binocular central vision loss were recruited and tested on a face identification-matching task. Gaze position was measured in real time, thanks to an eye tracker. In the visual enhancement condition, at any time during the screen exploration, the fixated face was segregated from background and considered as a region of interest that could be magnified into a region of augmented vision by the participant, if desired. In the natural exploration condition, participants also performed the matching task but without the visual aid. Response time and accuracy were analyzed with mixed-effects models to (1) compare the performance with and without visual aid and (2) estimate the usability of the system. RESULTS: On average, the percentage of correct response for the natural exploration condition was 41%. This value was significantly increased to 63% with visual enhancement (95% confidence interval, 45 to 78%). For the large majority of our participants (83%), this improvement was accompanied by moderate increase in response time, suggesting a real functional benefit for these individuals. CONCLUSIONS: Without visual enhancement, participants with age-related macular degeneration performed poorly, confirming their struggle for face recognition and the need to use efficient visual aids. Our system significantly improved face identification accuracy by 55%, proving to be helpful under laboratory conditions.

Long-Term Real-Life Efficacy and Safety of Repeated Ozurdex® Injections and Factors Associated with Macular Edema Resolution after Retinal Vein Occlusion: The REMIDO 2 Study.

PURPOSE: The objective was to study long-term real-life efficacy and safety of repeated Ozurdex® injections and factors associated with macular edema (ME) resolution after retinal vein occlusion. METHODS: Patients with ME after retinal vein occlusion, receiving Ozurdex®, were included to assess the following endpoints: visual acuity and central retinal thickness, retreatment, number of injections, side effects and ME resolution. ME resolution was defined as permanent discontinuation of intravitreal injections (IVTs) for at least 6 months after the last IVT. RESULTS: A total of 94 eyes were included with an average of 2.6 IVTs (max 6 IVTs). 58.6% of patients gained ≥15 letters and 51.1% of patients showed ME resolution. Among the resolved patients, 64.6% were treatment-naïve, 60.4% had branch retinal vein occlusion, and 78.1% gained ≥15 letters. CONCLUSIONS: Ozurdex® seemed to be a valuable treatment which may allow to achieve long-term anatomical and functional improvements and ME resolution with a minimum number of IVTs.

Efficacy and Safety of Intravitreal Dexamethasone Implant in Patients with Diabetic Macular Edema.

PURPOSE: To evaluate the efficacy and safety of intravitreal implant of dexamethasone (Ozurdex®) in diabetic macular edema (DME). METHODS: This was a retrospective multicenter noncomparative study. Seventy-eight patients with DME followed for at least 6 months were included (P1.5 Network). Best-corrected visual acuity (BCVA), central retinal thickness (CRT), intraocular pressure (IOP) and cataract progression were studied at baseline and then at 1, 2, 4 and 6 months. RESULTS: The mean CRT decrease from baseline was 145.2 µm at 6 months. The mean BCVA improvement from baseline was 6.7 at 6 months. An increase in IOP was observed for 11.7% of patients, and all patients were managed by topical treatment. No glaucoma or cataract surgery was necessary, and no endophthalmitis was reported. CONCLUSIONS: One injection of Ozurdex has an anatomical and functional effectiveness for the treatment of DME. Side effects were rare and manageable in our practice. © 2015 S. Karger AG, Basel.

Method to Quickly Map Multifocal Pupillary Response Fields (mPRF) Using Frequency Tagging.

We present a method for mapping multifocal Pupillary Response Fields in a short amount of time using a visual stimulus covering 40° of the visual angle divided into nine contiguous sectors simultaneously modulated in luminance at specific, incommensurate, temporal frequencies. We test this multifocal Pupillary Frequency Tagging (mPFT) approach with young healthy participants (N = 36) and show that the spectral power of the sustained pupillary response elicited by 45 s of fixation of this multipartite stimulus reflects the relative contribution of each sector/frequency to the overall pupillary response. We further analyze the phase lag for each temporal frequency as well as several global features related to pupil state. Test/retest performed on a subset of participants indicates good repeatability. We also investigate the existence of structural (RNFL)/functional (mPFT) relationships. We then summarize the results of clinical studies conducted with mPFT on patients with neuropathies and retinopathies and show that the features derived from pupillary signal analyses, the distribution of spectral power in particular, are homologous to disease characteristics and allow for sorting patients from healthy participants with excellent sensitivity and specificity. This method thus appears as a convenient, objective, and fast tool for assessing the integrity of retino-pupillary circuits as well as idiosyncrasies and permits to objectively assess and follow-up retinopathies or neuropathies in a short amount of time.

Efficacy and Safety of 0.19-mg Fluocinolone Acetonide Implant in Postoperative Cystoid Macular Edema after Pars Plana Vitrectomy: the ILUCYD study.

PURPOSE: To assess the efficacy and safety of 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (Iluvien®) in treating chronic postoperative cystoid macular edema (PCME) after pars plana vitrectomy. DESIGN: Retrospective multicentric case series in clinical settings. SUBJECTS: Patients with chronic PCME who underwent vitrectomy in tertiary care centers in France. All eyes had a documented good response to the DEX implant prior to FAc implantation. METHODS: Review of charts and OCT scans of patients treated with a FAc intravitreal implant. MAIN OUTCOME MEASURES: The primary endpoints were the best-corrected visual acuity (BCVA) and central retinal thickness (CRT). Secondary endpoints were the intraocular pressure (IOP); proportion of patients maintaining a BCVA ≥20/40; need for additional non-study treatment; differences between eyes that underwent a single and multiple surgeries and OCT biomarkers of better BCVA. RESULTS: Forty-nine eyes of 49 patients with a mean follow-up of 24.5 ± 3.9 months were included. The mean BCVA increased from 0.40 ± 0.26 logMAR at baseline to 0.32 ± 0.24 logMAR at month 24 (M24) (p=0.0035). The mean CRT decreased from 409.37 ± 139.43 µm at baseline to 340 ± 91 µm at M24 (p=0.0001). The mean IOP was 14.0 ± 4 mmHg at baseline and remained stable at 14.03 ± 4.1 mmHg at M24 (p=0.99). During the follow-up, the IOP exceeded 21 mmHg in 9 eyes. The IOP rise was controlled with topical therapy in all eyes except one, which required cyclophotocoagulation. The BCVA was ≥20/40 in 47% of eyes (95% CI: 34%-61%) at baseline and in 58% of eyes at M24 (95% CI: 41%-73%). At M18, the likelihood of achieving a BCVA ≥20/40 was higher in eyes with intact external limiting membrane and ellipsoid zone. Additional dexamethasone implant (DEXi) was injected in 14 eyes (28.57%). The treatment burden of 2.45 ± 1.35 DEXi/year was decreased to 0.57 ± 0.60 DEXi/year after FAc implantation (p=0.001). CONCLUSION: FAc implant improved the BCVA and reduced the CRT in eyes with chronic PCME after vitrectomy. The IOP rise could be anticipated by the previous response to corticosteroids. FAc implant in eyes with chronic PCME also allowed reducing the treatment burden.

Corneal ectasia after intrastromal presbyopic surgery.

PURPOSE: To report histopathologic findings in a case of bilateral corneal ectasia following intrastromal femtosecond laser presbyopia surgery. METHODS: Case report. RESULTS: A 56-year-old patient was referred for bilateral corneal ectasia. He was treated for hyperopia using LASIK twice in both eyes. A bilateral femtosecond laser intrastromal presbyopia correction was secondarily performed. The patient complained of progressive loss of distance visual acuity shortly after. Corneal topography showed a bilateral central corneal protrusion. Rigid contact lenses were successfully fitted on the right eye and, because the patient still complained, a deep anterior lamellar keratoplasty was performed in the left eye. Light and electronic microscopy of the corneal button revealed that the inner intrastromal incision crossed the LASIK interface and led to stromal bed dehiscence. CONCLUSION: This case illustrates that intrastromal refractive surgery should not be recommended in eyes previously treated by lamellar refractive surgery.

A New Vessel-Based Method to Estimate Automatically the Position of the Nonfunctional Fovea on Altered Retinography From Maculopathies.

Purpose: The purpose of this study was to validate a new automated method to locate the fovea on normal and pathological fundus images. Compared to the normative anatomic measures (NAMs), our vessel-based fovea localization (VBFL) approach relies on the retina's vessel structure to make predictions. Methods: The spatial relationship between the fovea location and vessel characteristics is learnt from healthy fundus images and then used to predict fovea location in new images. We evaluate the VBFL method on three categories of fundus images: healthy images acquired with different head orientations and fixation locations, healthy images with simulated macular lesions, and pathological images from age-related macular degeneration (AMD). Results: For healthy images taken with the head tilted to the side, the NAM estimation error is significantly multiplied by 4, whereas VBFL yields no significant increase, representing a 73% reduction in prediction error. With simulated lesions, VBFL performance decreases significantly as lesion size increases and remains better than NAM until lesion size reaches 200 degrees2. For pathological images, average prediction error was 2.8 degrees, with 64% of the images yielding an error of 2.5 degrees or less. VBFL was not robust for images showing darker regions and/or incomplete representation of the optic disk. Conclusions: The vascular structure provides enough information to precisely locate the fovea in fundus images in a way that is robust to head tilt, eccentric fixation location, missing vessels, and actual macular lesions. Translational Relevance: The VBFL method should allow researchers and clinicians to assess automatically the eccentricity of a newly developed area of fixation in fundus images with macular lesions.

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.

Costs comparison of treating diabetic macular edema with aflibercept, ranibizumab or dexamethasone at 1 year in France (INVICOST study).

PURPOSE: INVICOST, a medico-economic analysis, compared costs of managing treatment-naive patients with diabetic macular edema (DME) receiving intravitreal injections (IVIs) of aflibercept (AFL), dexamethasone implant (DXI) or ranibizumab (RAN) over 1 year. METHODS: Healthcare resource use and associated costs were estimated using individual patient data from INVICTUS, a prospective, open-label, monocentric study. Healthcare costs comprised direct medical costs such as drug acquisition and administration, consultations and ophthalmological procedures. Costs were assessed from the French National Health Insurance perspective using published national tariffs expressed in 2019 euros. RESULTS: Of the 60 treated eyes, 48 had no treatment switch; 14 received AFL, 19 received DXI and 15 received RAN. AFL-treated eyes received an average of 6.5 IVIs, DXI-treated patients received 2 IVIs and RAN-treated received 6.8 IVIs. All treated eyes received an initial prescription for adjunctive ocular medications and 349 follow-up procedures were performed including an average of 3.9 optical coherence tomography and 3.2 retinography procedures per eye. Average total direct cost of per-eye treatment was €4516 (€1128-€8257). Average cost was €5782 for eyes treated with AFL, €2779 with DXI and €5536 with RAN. Drug therapy was the cost driver: €4394 (76%) for AFL, €1915 for DXI (69%) and €4268 (77%) for RAN. CONCLUSION: The difference in total treatment cost is largely explained by the significantly lower frequency of IVI and annual cost of therapy with DXI, compared with AFL and RAN. INVICOST is the first study comparing treatment costs with AFL, DXI and RAN in France in current clinical practice.

Recommendations for the management of diabetic macular oedema with intravitreal dexamethasone implant: A national Delphi consensus study.

PURPOSE: The intravitreal dexamethasone implant (DEX-I) is an alternative to anti-VEGF for the first-line treatment of diabetic macular oedema (DME). However, several questions remain regarding its routine use and its place in certain situations not always specified in current recommendations. A national consensus approach was, therefore, initiated by French retinal experts. METHODS: An iterative Delphi consensus approach was used. A steering committee (SC) of seven experts analysed data from the literature to formulate statements divided into five key areas of treatment. These statements were submitted to the independent and anonymous electronic vote of 87 French retina experts among whom 39 expressed their opinion and therefore constituted the voting panel. RESULTS: After two rounds of voting, 22 and 7 of 38 statements received a strong consensus and a good consensus, respectively. The consensus level was higher for statements regarding first-line indications and safety of DEX-I compared to those regarding efficacy assessment, reprocessing time or pathophysiological biomarkers. The panellists recommended the preferential use of DEX-I for patients with limited availability for multiple injections, those who needed to undergo cataract surgery or who had a recent cardiovascular history, and as a therapeutic alternative to anti-VEGF in patients with a history of vitrectomy, retinal serous detachment, hyper-reflective points or dry exudates in optical coherence tomography (OCT). However, some statements proposed by SC experts were not validated. CONCLUSION: This study provides some key recommendations to clinicians treating diabetic macular oedema, which may be useful when using intravitreal dexamethasone implants in daily practice.

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.