Assessment of intravitreal anti-VEGF drugs and dexamethasone for retinal diseases in real world setting: A multi-centre prospective study from Southern Italy.

Describe drug utilisation and clinical outcomes of intravitreal anti-VEGF drug and dexamethasone use in the real-world setting in Southern Italy using data from multi-centre study of retinal disease. Clinical data of retinal disease patients treated with anti-VEGF drugs and dexamethasone implant in 6 out-patient ophthalmology centres from Southern Italy were collected by means of an electronic case report form. Patients receiving at least one intravitreal injection/implant of the study drugs were followed for up to two years and described in terms of demographics and clinical characteristics. Drug utilisation patterns were described. A sign-rank test was used to compare clinical data on visual acuity and other ophthalmic parameters from baseline at different follow-up times for each indication. Data from 1327 patients was collected. Most patients were diagnosed with age-related macular degeneration (AMD) (660, 49.7%), followed by diabetic macular oedema (423, 31.9%), retinal vein occlusion (164, 12.3%), and myopic choroidal neovascularization (80, 6.0%). Patients were followed for a median of 10.3 months (interquartile range: 3.6 - 24.7 months). Mean patient age was 69.7 (±10.9) years and 54.2% were males. Ranibizumab (55.4%) and aflibercept (27.5%) were the most commonly used drugs. Baseline visual acuity significantly improved by about 0.05 to 0.1 logMAR at all follow-up times for AMD and RVO but less consistently for the other diseases. Intravitreal ranibizumab use accounted for half of all treatment for retinal diseases in a Southern Italian out-patient setting. Patients treated with anti-VEGF drugs for AMD and RVO in Southern Italy experienced significant improvement in VA.

Polypoidal choroidal vasculopathy in pachychoroid: combined treatment with photodynamic therapy and aflibercept.

INTRODUCTION: To evaluate the effects of combined therapy using intravitreal Aflibercept (IVA) and photodynamic therapy (PDT) on polypoidal choroidal vasculopathy related to pachychoroid disease (PPCV). METHODS: Patients with PPCV were treated with PDT combined with 3 IVA injections on a monthly basis, followed by pro re nata criteria. The 12-month follow-up consisted of multiple revaluations of visual acuity and SS-OCT parameters of clinical activity. RESULTS: Nineteen eyes were included in the study; mean age was 65.5 years. Visual acuity improved after 12 months (0.35 ± 0.25 to 0.2 ± 0.20 logMAR, p = 0.005). Percentage of eyes with intraretinal and subretinal fluid reduced from baseline to the 12-month follow-up (from 52.6 to 10.5%, p = 0.12, and from 89.5 to 5.3% p = 0.0009, respectively). Central retinal and mean macular thicknesses reduced (258 ± 39.6 to 204.8 ± 38.8 µm p = 0.04 and 293.8 ± 32.1 to 248.1 ± 29.6 µm p = 0.017, respectively). Central choroidal and mean choroidal thicknesses also displayed a reduction (328.6 ± 54.9 to 289.8 ± 44.6 µm p = 0.001 and 314.5 ± 55.3 to 287.9 ± 47.6 µm p = 0.015, respectively). The mean number of injections was 4.6/year. CONCLUSION: The results support the use of a combined therapy with Aflibercept and PDT in PPCV. This treatment would act in synergy, with anti-VEGF controlling exudation and PDT closing the aneurysmal vessel and reducing choroidal congestion.

Intraoperative dexamethasone intravitreal implant in diabetic macular edema patients undergoing phacoemulsification: The CataDex study.

PURPOSE: To assess the impact of preoperative intravitreal dexamethasone implant (DexI) on functional and anatomic outcomes in patients with diabetic macular edema (DME) who underwent phacoemulsification cataract surgery. METHODS: Prospective and non-comparative study conducted on consecutive DME patients undergoing cataract surgery. DexI was administered 15 days before surgery and in a pro re nata regime after surgery. Main outcome measures were mean change in central retinal thickness (CRT), central subfield thickness (CST), total macular volume (TMV), and central subfield volume (CSV) from baseline to month-12. Secondary outcome was mean change in best corrected visual acuity (BCVA). RESULTS: Forty eyes were included in the study. CRT significantly decreased from 410.4 ± 64.8 µm at baseline to 303.2 ± 24.3 µm at month-12, p < 0.0001. Similarly, CST was significantly reduced from 436.4 ± 120.4 µm at baseline to 322.9 ± 54.2 µm at month-12, p < 0.0001. Total macular volume and CSV were significantly reduced from 9.95 ± 1.68 mm3 and 0.38 ± 0.11 mm3 at baseline to 8.49 ± 0.83 mm3 and 0.31 ± 0.05 mm3 at month-12, respectively (p < 0.0001 each, respectively). BCVA significantly improved from 0.26 ± 0.17 Snellen equivalent at baseline to 0.65 ± 0.19 at month-12, p < 0.0001. Mean DexI administered during the study were 2.0 ± 0.3. Neither DME subtype nor previous treatment status had any effect on functional or anatomic outcomes. Regarding safety, one (2.5%) eye developed ocular hypertension, which was successfully controlled with topical hypotensive treatment. CONCLUSIONS: DexI was and effective and safe strategy for managing DME in diabetic patients undergoing uneventful cataract surgery.

Bilateral Ultrathin Descemet's Stripping Automated Endothelial Keratoplasty vs. Bilateral Penetrating Keratoplasty in Fuchs' Dystrophy: Corneal Higher-Order Aberrations, Contrast Sensitivity and Quality of Life.

Background and Objectives: The objective of this paper is to compare the visual outcomes and quality of life (QoL) after bilateral ultrathin Descemet's stripping automated endothelial keratoplasty (UT-DSAEK) with bilateral penetrating keratoplasty (PK) for Fuchs' endothelial dystrophy (FED). Materials and Methods: Retrospective comparative cohort study, including 11 patients with FED who underwent bilateral PK and 13 patients with FED who underwent bilateral UT-DSAEK. All patients were already pseudophakic or had undergone a combined cataract procedure. The main outcomes were corrected distance visual acuity (CDVA) corneal higher-order aberrations (HOAs), contrast sensitivity (CS) and quality of life (QoL). Results: The mean follow-up after the second eye surgery was 32.5 ± 10.2 months in PK and 19.6 ± 8.6 months in UT-DSAEK patients. The CDVA in the UT-DSAEK group was significantly better than in the PK one (0.18 ± 0.07 vs. 0.35 ± 0.16 logMAR, p < 0.0001). The mean anterior corneal total HOAs of the central 5 mm were significantly lower in UT-DSAEK eyes than in PK eyes (0.438 ± 0.078 µ and 1.282 ± 0.330 µ respectively, p < 0.0001), whilst the mean posterior total HOAs did not differ between groups (0.196 ± 0.056 µ and 0.231 ± 0.089 µ, respectively, p = 0.253). The CS was lower at 0.75 and 1.5 cycles/degree in P the K group when compared to the DSAEK one (p = 0.008 and 0.005, respectively). The QoL scores by the NEI RQL-42 test exhibited better values in DSAEK patients in 9 out of 13 scales. Conclusion: Our study confirms that UT-DSAEK provides a better visual function in terms of CDVA and CS, together with lower HOAs, when compared to PK. Hence, the vision-related QoL, binocularly evaluated by the NEI RQL-42 items, indicates a higher satisfaction in UT-DSAEK eyes.

Intravitreal dexamethasone implant one month before versus concomitant with cataract surgery in patients with diabetic macular oedema: the dexcat study.

PURPOSE: To report clinical outcomes of two different timings of intravitreal dexamethasone (DEX) implant administration for prevention of diabetic macular oedema (DME) worsening following cataract surgery. METHODS: This multicentre, retrospective study included patients with DME who received an intravitreal DEX implant 1 month before cataract surgery, 'precataract DEX' group, or at the time of cataract surgery, 'concomitant treatments' group. Inclusion criteria were a follow-up ≥3 months and ophthalmological examination with optical coherence tomography (OCT) imaging at baseline (cataract surgery) and throughout follow-up. Anatomical improvement was considered to be a decrease in OCT central subfield (CSF) thickness ≥20% compared to baseline. The primary outcomes were anatomical and functional results at 3 months. RESULTS: Two hundred twenty-one patients were included: 136 in the 'precataract DEX' group and 85 in the 'concomitant treatments' group. At 3 months, a reduction of CSF thickness ≥ 20% was found in 7.3% of eyes in the 'precataract DEX group' and in 83.7% of eyes in the 'concomitant treatments' group (p < 0.001), with mean CSF thickness lower in the latter group (371 ± 52 µm versus 325 ± 57 µm, p < 0.001). At 3 months, mean best-corrected visual acuity had improved from baseline in both groups (p < 0.001), with no difference between groups (p = 0. 20). No serious systemic adverse events were reported. CONCLUSION: Both approaches prevented a worsening of DME, showing a comparable visual outcome. Dexamethasone (DEX) implant given at the same time as cataract surgery provided a better anatomical outcome.

Preoperative, Intraoperative and Postoperative Corticosteroid Use as an Adjunctive Treatment for Rhegmatogenous Retinal Detachment.

The treatment for rhegmatogenous retinal detachment (RRD) is surgery, including pars plana vitrectomy (PPV) and scleral buckling (SB). Despite surgical advances, degeneration of the photoreceptors and post-operative complications, such as proliferative vitreoretinopathy (PVR), often occurs as the result of inflammation, preventing complete visual recovery or causing RRD recurrence. There is increasing evidence that in the presence of RRD, the activation of inflammatory processes occurs and the surgery itself induces an inflammatory response. This comprehensive review focuses on the use of different formulations of corticosteroids (CCS), as an adjunctive treatment to surgery, either PPV or SB, for RRD repair. The purpose was to review the efficacy and safety of CCS in improving functional and anatomical outcomes and in preventing postoperative complications. This review is organized according to the timing of CCS administration: preoperative, intraoperative, and postoperative. The evidence reviewed supported the role of the pre-operative use of CCS in the treatment of combined RRD and choroidal detachment (CD), reducing CD height. No solid consensus exists on intraoperative and postoperative use of CCS to treat and prevent postoperative complications. However, a large randomized clinical trial including more than 200 eyes suggested that oral prednisone after surgery decreases the rate of postoperative grade B PVR.

How Have Intravitreal Anti-VEGF and Dexamethasone Implant Been Used in Italy? A Multiregional, Population-Based Study in the Years 2010-2016.

PURPOSE: To describe intravitreal anti-VEGF drug and dexamethasone use in four Italian regions. METHODS: Four regional claims databases were used to measure drug prevalence, compare dosing intervals to those recommended in the summary of product characteristics (SPC), and identify switchers. Bilateral treatment and diabetic macular edema (DME) coding algorithms were validated, linking claims with a sample of prospectively collected ophthalmological data. RESULTS: Overall, 41,836 patients received ≥1 study drug in 2010-2016 (4.8 per 10,000 persons). In 2016, anti-VEGF drug use ranged from 0.8 (Basilicata) to 5.7 (Lombardy) per 10,000 persons while intravitreal dexamethasone use ranged from 0.2 (Basilicata) to 1.4 (Lombardy) per 10,000 persons. Overall, 40,815 persons were incident users of study drugs. Among incident users with ≥1 year of follow-up (N = 30,745), 16.0% (N = 30,745), 16.0% (N = 30,745), 16.0% (. CONCLUSION: Study drug use increased over time in Lombardy, Basilicata, Calabria, and Sicily, despite a large heterogeneity in prevalence of use across regions. Drug treatment appeared to be partly in line with SPC, suggesting that improvement in clinical practice may be needed to maximize drug benefits.

Infracyanine Green vs. Brilliant Blue G in Inverted Flap Surgery for Large Macular Holes: A Long-Term Swept-Source OCT Analysis.

Background and Objectives: To compare the long-term toxicity of infracyanine green (IFCG) to brilliant blue G (BBG) in inverted internal limiting membrane flap surgery (I-ILMFS) for large, full-thickness macular holes (FTMHs). Materials and Methods: Prospective randomized study including 39 eyes with ≥ 400 µm idiopathic FTMH who underwent I-ILMFS with either IFCG or BBG. Postoperative 6- and 12-month corrected distance visual acuity (CDVA), closure rate, and swept-source optical coherence tomography parameters, including ellipsoid zone (EZ) and external limiting membrane (ELM) mean defect length, central foveal thicknesses (CFT), parafoveal macular thickness (MT), ganglion cells and inner plexiform layer (GCL++) thickness, and peripapillary nerve fiber layer (pRNFL) thickness, were compared. Results: Nineteen eyes were included in the IFCG group and 20 eyes in the BBG group. In all cases a FTMH closure was found. CDVA improved at 6 and 12 months in both groups (p < 0.0005); the increase at 12 months was greater in the BBG group (p = 0.036). EZ and ELM defects did not differ between groups at either follow-up time. CFT at 12 months was greater in the BBG group (p = 0.041). A 12-months compared to 6-months MT decrease was present in both groups (p < 0.01). The GCL++ superior inner sector was thicker in the BBG group at 12 months (p = 0.036), as were the superior outer sector (p = 0.039 and p = 0.027 at 6 and 12 months, respectively) and inferior outer sector (p = 0.011 and p = 0.009 at 6 and 12 months, respectively). Conclusion: In our study BBG in I-ILMFS exhibits better long-term CDVA and retinal thickness than does IFCG, suggesting a lesser toxicity from BBG. These findings support the use of BBG over IFCG in I-ILMFS.

Vascular changes after vitrectomy for rhegmatogenous retinal detachment: optical coherence tomography angiography study.

PURPOSE: To analyse the postoperative foveal avascular zone (FAZ) area, superficial vessel density (SVD) and deep vessel density (DVD) and their correlation with functional (best-corrected visual acuity, BCVA) and anatomical outcomes (foveal macular thickness, FMT) after surgery for rhegmatogenous retinal detachment (RRD) repair. METHOD: Patients with RRD eyes, successfully treated with a single pars plana vitrectomy (PPV) with gas tamponade and a minimum 12 months follow-up, were re-examined. Foveal avascular zone (FAZ) area, SVD, DVD and FMT were evaluated by using optical coherence tomography angiography (OCTA) and compared to fellow eye. RESULTS: Fifty-six patients with macula-on and 37 with macula-off RRD were included in the study. In both groups, no difference in FMT and FAZ area was found compared to fellow eyes. In macula-on RRD eyes, a lower parafoveal DVD (p = 0.001) was detected; FAZ area was related to FMT (p = 0.025), and the postoperative BCVA was correlated with parafoveal DVD (p = 0.010) and FAZ area (p = 0.003). In macula-off RRD eyes, lower parafoveal SDV (p = 0.012), and foveal and parafoveal DVD (p = 0.012 and p < 0.001, respectively) were observed. BCVA was related to FAZ area (p = 0.012), foveal SVD (p = 0.005) and parafoveal DVD (p = 0.010). CONCLUSION: Rhegmatogenous retinal detachment eyes successfully treated with PPV had lower vessel density in the superficial and deep retinal plexus compared to fellow healthy eyes; BCVA was related to FAZ area and vessel density.

PFN1 and integrin-ß1/mTOR axis involvement in cornea differentiation of fibroblast limbal stem cells.

Ex vivo limbal stem cell transplantation is the main therapeutic approach to address a complete and functional re-epithelialization in corneal blindness, the second most common eye disorder. Although important key points were defined, the molecular mechanisms involved in the epithelial phenotype determination are unclear. Our previous studies have demonstrated the pluripotency and immune-modulatory of fibroblast limbal stem cells (f-LSCs), isolated from the corneal limbus. We defined a proteomic profile especially enriched in wound healing and cytoskeleton-remodelling proteins, including Profilin-1 (PFN1). In this study we postulate that pfn-1 knock down promotes epithelial lineage by inhibiting the integrin-ß1(CD29)/mTOR pathway and subsequent NANOG down-expression. We showed that it is possible modulate pfn1 expression levels by treating f-LSCs with Resveratrol (RSV), a natural compound: pfn1 decline is accompanied with up-regulation of the specific differentiation epithelial genes pax6 (paired-box 6), sox17 (sex determining region Y-box 17) and ΔNp63-α (p63 splice variant), consistent with drop-down of the principle stem gene levels. These results contribute to understand the molecular biology of corneal epithelium development and suggest that pfn1 is a potential molecular target for the treatment of corneal blindness based on epithelial cell dysfunction.

Efficacy of Three Different Prophylactic Treatments for Postoperative Nausea and Vomiting after Vitrectomy: A Randomized Clinical Trial.

Postoperative nausea and vomiting (PONV) after vitreoretinal surgery may potentially be associated with severe complications, such as suprachoroidal hemorrhage. The purpose of the present multicenter clinical trial (NCT02386059) was to assess the efficacy of three different prophylactic treatments for PONV after vitrectomy under local anesthesia. Patients undergoing primary vitrectomy were randomized to the control arm or to one of the treatment arms (4 mg ondansetron, 4 mg dexamethasone, combination of the two drugs). The primary outcome measure was the proportion of complete response (no nausea, no vomiting, no retching, and no use of antiemetic rescue medication) during 24 h after vitrectomy. Secondary outcomes included the severity standardized score of PONV, postoperative pain standardized score, and rate of ocular and non-ocular adverse events. Baseline demographics of the 1287 patients were comparable between the four arms. The combined therapy group showed a statistically significant lower incidence of PONV compared to the placebo and monotherapy (p < 0.001). PONV severity was also reduced in the combination group compared to the others (p < 0.001). Postoperative pain scores and adverse events were comparable among the four groups. Combined therapy with dexamethasone and ondansetron was the most effective treatment for reducing the incidence and severity of PONV in patients undergoing vitrectomy under local anesthesia.

Determinants of inappropriate hospitalization in cataract surgery in the south of Italy: a retrospective study.

PURPOSE: To analyze the frequency of inappropriate hospitalization in cataract surgery and the type of related determinants. METHODS: A nested retrospective case-control study was carried out on 2708 consecutive cataract surgery patients operated between January 2013 and December 2015. All cases with inappropriate hospitalization (day surgery or ordinary hospitalization) were compared with a control group of cases treated in an appropriate (day service) regimen. The predictive value for inappropriate admissions to the hospital was assessed using a logistic regression model. Significant variables from the univariate analysis were included in a multivariate model. RESULTS: Forty-five cases (< 2%) of inappropriate hospital admissions were recorded. Residence, heart disease, tremors, anticoagulants, intraoperative floppy iris syndrome were not related to appropriateness, while psychotic disorder (OR 12.571, p = 0.018), anxiety-depressive syndrome (OR 7.818, p = 0.010) and use of antipsychotropic drugs (OR 7.724, p = 0.002) were related to the inappropriateness of admission by univariate and multivariate analysis. Previous systemic surgeries were predictors of ordinary hospitalization by logistic regression analysis. A greater presence of hypertension, diabetes mellitus and fellow eye pseudophakia was noticed in appropriate hospitalization cases. CONCLUSIONS: This study detects the predictive role of psychiatric disorders as determinants of hospitalization inappropriateness in cataract surgery. The negative correlation between inappropriate hospitalization and conditions such as hypertension and diabetes points out that in the elderly population common diseases are effectively addressed, in contrast to the difficult management of psychiatric patients. Prior systemic interventions represent factors inducing transfer from day service to ordinary hospitalization, highlighting communication problems related to difficult coping with an outpatient surgery setting.

Carbonic Anhydrase Inhibitor with Topical NSAID Therapy to Manage Cystoid Macular Edema in a Case of Gyrate Atrophy.

PURPOSE: Gyrate atrophy of the choroid and retina (GACR) is a rare chorioretinal dystrophy characterized by a deficiency of the enzyme ornithine aminotransferase, inherited in an autosomal recessive pattern. CASE REPORT: We report a case of a 17-year-old girl with GACR, for whom the level of serum ornithine had been reduced by an arginine-restricted diet. The patient was responsive to an association of topical nonsteroidal anti-inflammatory drugs (NSAIDs) and a carbonic anhydrase inhibitor (CAI) to reduce cystoid macular edema (CME). CONCLUSIONS: The efficacy of topical NSAIDs and systemic CAI association indicates that the imbalance in the distribution of retinal pigment epithelium membrane-bound carbonic anhydrase could play a major role in CME pathogenesis in GACR. To our knowledge, this is the first case of therapy with CAI treatment for GACR-related CME.

Association of neovascular age-related macular degeneration with month and season of birth in Italy.

In order to investigate the influence of season and month of birth on the risk of neovascular age-related macular degeneration (n-AMD) in Italy, we evaluated the month birth and sex of all patients, recorded in the anti-vascular endothelial growth factor (VEGF) monitoring registry of the Italian Medicines Agency, born between 1925-1944, who received intravitreal anti-VEGF injections for n-AMD between January 1, 2013 and July 29, 2015. The numbers of all births in Italy in the same years, extracted from the Italian National Institute of Statistics, were used to calculate the expected number of n-AMD cases. Overall, 45,845 patients (19,207 men, 26,638 women) received intravitreal anti-VEGF for n-AMD; in the same years, 20,140,426 people (10,334,262 male, 9,806,164 female) were born in Italy. Comparing the observed number of n-AMD cases with the expected number of n- AMD cases in each season, we found that the season-specific risk for n-AMD was 2.5% higher for those born in summer (OR=1.03, Bonferroni-corrected P=0.008) and 3% lower for those born in winter (OR=0.96, Bonferroni-corrected P=0.0004). When considering the month of birth, the risk of n-AMD was 5.9% lower for people born in January (OR=0.93, Bonferroni-corrected P=0.0012). The factors causing such differences should be determined.

Donor age and long-term culture do not negatively influence the stem potential of limbal fibroblast-like stem cells.

BACKGROUND: In regenerative medicine the maintenance of stem cell properties is of crucial importance. Ageing is considered a cause of reduced stemness capability. The limbus is a stem niche of easy access and harbors two stem cell populations: epithelial stem cells and fibroblast-like stem cells. Our aim was to investigate whether donor age and/or long-term culture have any influence on stem cell marker expression and the profiles in the fibroblast-like stem cell population. METHODS: Fibroblast-like stem cells were isolated and digested from 25 limbus samples of normal human corneo-scleral rings and long-term cultures were obtained. SSEA4 expression and sphere-forming capability were evaluated; cytofluorimetric assay was performed to detect the immunophenotypes HLA-DR, CD45, and CD34 and the principle stem cell markers ABCG2, OCT3/4, and NANOG. Molecular expression of the principal mesenchymal stem cell genes was investigated by real-time PCR. Two-dimensional gel electrophoresis and mass spectrometric sequencing were performed and a stable proteomic profile was identified. The proteins detected were explored by gene ontology and STRING analysis. The data were reported as means ± SD, compared by Student's unpaired t test and considering p < 0.05 as statistically significant. RESULTS: The isolated cells did not display any hematopoietic surface marker (CD34 and CD45) and HLA-DR and they maintained these features in long-term culture. The expression of the stemness genes and the multilineage differentiation under in-vitro culture conditions proved to be well maintained. Proteomic analysis revealed a fibroblast-like stem cell profile of 164 proteins with higher expression levels. Eighty of these showed stable expression levels and were involved in maintenance of "the stem gene profile"; 84 were differentially expressed and were involved in structural activity. CONCLUSIONS: The fibroblast-like limbal stem cells confirmed that they are a robust source of adult stem cells and that they have good plasticity, good proliferative capability, and long-term maintenance of stem cell properties, independently of donor age and long-term culture conditions. Our findings confirm that limbal fibroblast-like stem cells are highly promising for application in regenerative medicine and that in-vitro culture steps do not influence their stem cell properties. Moreover, the proteomic data enrich our knowledge of fibroblast-like stem cells.

Biodegradable collagen matrix implant versus mitomycin-C in trabeculectomy: five-year follow-up.

BACKGROUND: Clinical studies comparing trabeculectomy augmented with Ologen implant (OLO) versus trabeculectomy plus mitomycin-C (MMC) show contradictory results. To obtain long-term data, we report an extended 5-year follow-up trial evaluating the safety and efficacy of OLO as adjuvant compared to low-dosage MMC in trabeculectomy. METHODS: Forty glaucoma patients (40 eyes) assigned to trabeculectomy with MMC or Ologen. PRIMARY OUTCOME: target IOP at ≤21, ≤17 and ≤15 mmHg; complete and qualified success endpoint rates. SECONDARY OUTCOMES: visual acuity (VA), mean deviation (MD), bleb evaluation, according to Moorfields Bleb Grading System (MBGS); spectral domain OCT (SD-OCT) bleb examination; number of glaucoma medications; frequency of postoperative complications. RESULTS: The mean preoperative IOP was 26.7(±5.2) in MMC and 27.3(±6.0) in OLO eyes. Mean 60-month percentage reduction in IOP was significant in both groups [40.9 (±14.2) and 42.1(±13.3) P = 0.01], with an endpoint value of 15.2 (±3.2) and 15.8 (±2.3) mmHg in MMC and OLO, respectively. Complete success rates at ≤ 21 mmHg target IOP were 65% and 70%, at ≤17 mm Hg 60% and 55%, and at the ≤15 mm Hg target IOP 35% and 45% in MMC and OLO, respectively. The Kaplan-Meier curves did not differ both for complete and qualified success at any target IOP, with no significant endpoint intergroup difference at ≤ 15 mm Hg (log-rank P = 0.595).The intergroup MBGS scores differed due to reduced central and peripheral vascularity in MMC group (P = 0.027; P = 0.041). SD-OCT analysis denied differences in bleb height between MMC vs OLO (140.5 ± 20.3 µ vs 129.2 ± 19.3 µ respectively; P =0.079). Mean antiglaucoma medications were significantly reduced (P < 0.0005) from 2.5 (±0.3) to 1.2 (±0.4) in MMC and from 2.6 (±0.2) to 1.4 (±0.3) in OLO group, with no intergroup differences (P = 0.08). Six (30%) cystic thin avascular blebs without oozing were recorded in the MMC group and 2 (10%) in the OLO group, without intergroup difference (P = 0.235). CONCLUSIONS: Our extended follow-up results confirm that Ologen implant yields efficacy and long-term success rates quite similar to MMC, with at least equivalent safety.

TREATMENT OF PERSISTENTLY OPEN MACULAR HOLES WITH HEAVY SILICONE OIL (DENSIRON 68) VERSUS C2F6. A PROSPECTIVE RANDOMIZED STUDY.

PURPOSE: To compare the efficacy of a mixture of silicone oil and perfluorohexyloctane (Densiron 68) with C2F6 gas endotamponade in the retreatment of persistently open full-thickness macular holes. METHODS: In this prospective randomized study, 21 consecutive patients who were unsuccessfully operated on for large idiopathic full-thickness macular hole were randomly assigned to undergo a second vitrectomy with 20% perfluoroethane gas (C2F6, Group A) or with Densiron 68 tamponade (Group B). PRIMARY OUTCOMES: Endpoint (12 months) full-thickness macular hole closure rate by spectral domain optical coherence tomography and logMAR corrected distance visual acuity. SECONDARY OUTCOMES: postoperative adverse events. RESULTS: The mean diameter of macular holes before the second pars plana vitrectomy was 680.3 ± 120.8 µm and 740.5 ± 105.3 µm in Groups A and B, respectively (P = 0.237); mean preoperative corrected distance visual acuity was 0.96 ± 0.36 logMAR and 1.12 ± 0.35 logMAR, respectively (P = 0.315). Endpoint full-thickness macular hole closure was obtained in 30% of patients (3/10) in Group A and in 82% (9/11) in Group B (P = 0.030). Corrected distance visual acuities were, respectively, 0.80 ± 0.25 logMAR and 0.55 ± 0.20 logMAR, with significant intergroup difference (P = 0.019); corrected distance visual acuity increased in Group B only (P = 0.003). No differences in complications were found. CONCLUSION: The results indicate that Densiron 68 tamponade could be a useful, safe, and more efficacious method than gas tamponade to retreat persisting macular holes.

A randomized trial of intravitreal bevacizumab vs. ranibizumab for myopic CNV.

AIMS: The aim was to compare the efficacy of intravitreal therapy with bevacizumab and ranibizumab for choroidal neovascularization (CNV) in pathologic myopia (PM). METHODS: This was a prospective multicenter randomized nonblinded trial. RESULTS: In seven centers, 78 eyes were randomized 1:1 to treatment with bevacizumab (group B, 40 eyes) or ranibizumab (group R, 38 eyes) given with an "on demand" regimen (PRN). The mean follow-up was 19 months (SD 2, range 12-24). The mean BCVA at baseline was 0.60 logMAR (20/80 Snellen equivalent, Seq) and 50 letter score (ls). Mean final BCVA was 0.51 LogMAR (20/63 Seq) and 57 ls (p = 0.0009 and p = 0.0002, respectively). In group B, mean basal BCVA was 0.52 logMAR (20/63 Seq) and 54 ls, and final BCVA was 0.51 logMar (20/63 Seq) and 57 ls. In group R, mean basal BCVA was 0.62 logMAR (20/80 Seq) and 45 ls, and the final values were 0.50 logMAR (20/63 Seq) and 58 ls. Statistical comparison of the two groups showed no significant difference (logMAR p = 0.90 and letters p = 0.78). Multivariate analysis showed no influence of age or previous photodynamic treatment (PDT) on final visual changes. The mean number of treatments in the first year was 2.7 in group B and 2.3 in group R (p = 0.09). CONCLUSION: Myopic CNV equally benefits from on-demand intravitreal injection of either bevacizumab or ranibizumab; the therapeutic effect is independent of previous PDT and age.

Pharmacologic pupil dilation as a predictive test for the risk for intraoperative floppy-iris syndrome.

PURPOSE: To evaluate the effect of α1-adrenergic receptor antagonists (α1-ARAs) on pupil diameter and determine whether the diameter predicts intraoperative floppy-iris syndrome (IFIS). SETTING: Ophthalmology Section, Palermo University, Palermo, Italy. DESIGN: Prospective cohort study. METHODS: Male outpatients taking tamsulosin, α(1)-ARAs, or no α(1)-ARAs having phacoemulsification were recruited. Pupils were measured 1 month preoperatively, immediately preoperatively, and postoperatively under mesopic low (0.4 lux) and high (4.0 lux) illumination after pharmacologic dilation. The IFIS severity was graded. RESULTS: Each group comprised 50 patients. Pharmacologic dilation in both α(1)-ARA groups was statistically significantly less than in the no α1-ARA group 1 month preoperatively, immediately before surgery, and postoperatively (P=.001, P<.0005, and P<.0005, respectively). The IFIS incidence differed significantly between the tamsulosin and other α(1)-ARA groups and the no α1-ARA group (P<.0005 and P=.017, respectively) and between the tamsulosin group and the other α1-ARA group (P=.027). On regression analysis, the hazard ratio for overall IFIS incidence was 3.8 in the other α(1)-ARA group (P=.012) and 10.1 in the tamsulosin group (P<.0005). Pupil size was inversely related to IFIS incidence and severity (P<.0005). A dilated pupil of 7.0 mm or smaller had 73% sensitivity and 95% specificity for predicting IFIS (P=.0001). CONCLUSIONS: Pupil dilation was inhibited by α(1)-ARAs, in particular tamsulosin. For a pupil 7.0 mm or smaller, the risk for IFIS existed regardless of α(1)-ARAs treatment, which surgeons should take into consideration.

Angioid streak-related choroidal neovascularization treated by intravitreal ranibizumab.

PURPOSE: The purpose of this study was to report the visual outcome of intravitreal therapy with ranibizumab of choroidal neovascularization secondary to angioid streaks after 1-year follow-up. METHODS: Nine patients (age, 58 +/- 4 years; range, 53-65 years) were treated with off-label intravitreal injections of 0.3 mg ranibizumab. Primary outcomes were best-corrected visual acuity changes (Early Treatment Diabetic Retinopathy Study logarithm of the minimum angle of resolution and letters) and optical coherence tomography macular thickness changes. RESULTS: Mean follow-up was 14 months (+/-2; range, 12-18 months). Mean visual acuity was 0.52 logarithm of the minimum angle of resolution and 30 letters (range, 0.2-1.2; 0-47 letters) at baseline and 0.37 logarithm of the minimum angle of resolution (P = 0.014) and 37 letters (range, 0-1.2; 2-55 letters) (P = 0.01) at the last examination. Seven of 9 patients (78%) gained vision (mean, 2 lines), 1 patient (11 %) was stable, and 1 patient (11 %) lost 1 line of vision (5 letters). Two patients (22%) gained >or=3 lines of visual acuity, no patient lost >1 line. Mean optical coherence tomography macular thickness was 262.4 microm (+/-34.4 standard deviation) at baseline and 216.4 microm (+/-19 standard deviation) at the last examination (P = 0.05). The mean number of injection was 5 (range, 3-7); 78% of patients needed to be retreated after the loading dose of 3 monthly injections. CONCLUSION: Ranibizumab can be considered as an effective therapy in angioid streak-related neovascularization, even if in an off-label setting.