Reproducibility of SIMPLE classification for diabetic retinopathy screening and its comparison to current Italian guidelines.

PURPOSE: To evaluate the reproducibility of SIMPLE (Single field Image Multi Parameters defined Lesions Extent), a new Diabetic Retinopathy (DR) classification for screening of 45° single field fundus pictures of patients with diabetes (PwDM), assessing DR, Diabetic Maculopathy (DMac) and referral rate agreement and comparing it to current Italian Guidelines (IG). MATERIALS AND METHODS: We conducted a retrospective, observational, multicentre study, collecting 1000 retinal 45° single field images of PwDM obtained during routine visits in two diabetes clinics. Three ophthalmologists evaluated each image, determining the presence and number of specific DR lesions and then assigning a stage according to the current IG for screening. SIMPLE staging was performed automatically via Excel software, based on the pre-specified DR characteristics observed by the graders. We analysed intra-centre, inter-centre and total inter-grader agreement for DR and DMac stage and referral rate of the two classifications. RESULTS: Agreement amongst the three graders was consistently higher when using SIMPLE classification than when using current IG classification. For DR, kappa (k) was 0.86 with IG and 0.95 with SIMPLE classification; for DMac, k-IG was 0.78, while k-SIMPLE was 0.96; concordance on the referral rate was 0.91 with IG and 0.99 with SIMPLE. Similar results were obtained in sub-analyses for the evaluation of intra-centre and inter-centre concordance. CONCLUSIONS: Our results suggest that the new SIMPLE classification has an excellent reproducibility amongst graders, comparable or superior to the current IG for DR screening proposed in 2015, improving the standardisation of the decision on referability.

Subthreshold yellow micropulse laser for treatment of diabetic macular edema: Comparison between fixed and variable treatment regimen.

PURPOSE: To compare the efficacy between fixed and variable treatment regimens of subthreshold yellow micropulse laser for the treatment of diabetic macular edema. METHODS: This is a retrospective, comparative, 12-month study of 39 eyes: 24 eyes received fixed treatment regimen of subthreshold micropulse laser treatment and 15 eyes underwent variable treatment regimen of subthreshold micropulse laser, all eyes were followed up for 12 months. Subthreshold micropulse laser was performed with the following parameters: 100 µm spot size on slit lamp, 5% duty cycle of 0.2 s, and 250 mW power. To choose the power of the variable treatment regimen of subthreshold micropulse laser group, continuous laser power was titrated to a barely visible burn and then switched to MicroPulse mode, multiplying the test burn power by 4 and using a 5% duty cycle of 0.2 s. Main outcomes included changes in central macular thickness and best-corrected visual acuity. RESULTS: At baseline, the mean LogMAR best-corrected visual acuity was 0.297 ± 0.431 in the variable treatment regimen of subthreshold micropulse laser group and 0.228 ± 0.341 in the fixed treatment regimen of subthreshold micropulse laser group. At the end of follow-up, the mean LogMAR best-corrected visual acuity was 0.289 ± 0.473 (p = 0.785) and 0.245 ± 0.376 (p = 0.480) in the variable and fixed treatment regimens of subthreshold micropulse laser groups, respectively. Similarly, central macular thickness decreased in both groups after treatment; at baseline, the mean central macular thickness was 371.06 ± 37.8 in the variable treatment regimen of subthreshold micropulse laser group and improved to 325.60 ± 110.0 µm (p = 0.025) at the end of the follow-ups, while it was 342.30 ± 35.4 in the fixed treatment regimen of subthreshold micropulse laser group and improved to 308.51 ± 67.5 (p = 0.037). CONCLUSION: Both treatment regimens are effective for the treatment of mild center-involving diabetic macular edema: fixed treatment appears more suitable minimizing treatment time and reducing the possible errors due to wrong titration in the switch from continuous to micropulse mode.

Long-term follow-up and "double layer sign" in patients affected by circumscribed choroidal hemangioma.

BACKGROUND: Photodynamic therapy has revolutionised the treatment of circumscribed choroidal hemangiomas. The aim of this report is to report the long-term follow-up of patients affected by circumscribed choroidal hemangioma treated using photodynamic therapy. MATERIALS AND METHODS: We retrospectively reviewed patients affected by circumscribed choroidal hemangioma examined at the Retinal Medical Department at the Eye Clinic in Florence. We studied circumscribed choroidal hemangiomas treated using photodynamic therapy with at least 1 follow-up examination. Verteporfin was administered intravenously for 10 min (6 mg/m2 body surface area). After infusion (5 min), a 689 nm laser was applied with a light dose of 50 J/cm2. RESULTS: Ten eyes of 10 patients with circumscribed choroidal hemangioma who underwent Photodynamic therapy were included in our series (2 females and 8 males; average age at diagnosis 47.8 ± 9.3 yrs.; age range: 27-56 years). Five patients (5/10; 50 %) received only the photodynamic treatment whereas 5 patients (5/10; 50 %) also received other treatments (laser photocoagulation, intravitreal injection). On average, the patients received 2 photodynamic treatments (range 1-4). Four patients (4/10, 40 %) had a > 5-year follow-up; (average 4.5 ± 3.7 yrs. range 6 months - 10 years). In 2 patients we identified the "double layer sign" at the optical coherence tomography examination on circumscribed choroidal hemangioma. CONCLUSIONS: In our series, photodynamic therapy was a safe and effective treatment for circumscribed choroidal hemangioma during long-term follow-up. The double layer sign, which can be detected in several choroidal pathologies, suggests common pathogenetic mechanisms for circumscribed choroidal hemangiomas and central serous chorioretinopathy/polypoidal choroidopathy spectrum disease.

Vision-related quality of life and locus of control in type 1 diabetes: a multicenter observational study.

AIMS: Diabetic retinopathy remains asymptomatic until its late stages but remains a leading cause of vision impairment and blindness. We studied quality of life and the ability to deal with the discomfort deriving from the presence of a chronic disease in patients with type 1 diabetes and different stages of retinopathy. METHODS: Multicenter collaborative observational study involving nine centers screening for retinopathy in different areas of Italy. The National Eye Institute 25-item visual functioning questionnaire and the locus of control tool were administered to 449 people with type 1 diabetes between February 2016 and March 2018. Socio-demographic and clinical data were collected. RESULTS: On multivariable analysis, severe retinopathy is associated with worse scores for general vision, ocular pain, near vision activities, distance vision activities, driving, color vision, peripheral vision and lower values of internal control, independently of visual acuity. Women had a perception of worse general health, distance vision activities and driving, and lower internal control and trust in others. Worse scores for visual-specific social functioning, visual-specific mental health, visual-specific role difficulties, visual-specific dependency and peripheral vision were associated with higher HbA1c levels. Fatalism increased with rising HbA1c levels. CONCLUSIONS: These results confirm that a gap exists between patients' knowledge and expectations on retinopathy and providers' expertise and assumptions. To bridge this gap, patient-centered education and engaging approaches may be more effective than simple information given during consultations.

Treatment of macular serous neuroretinal detachment in tilted disk syndrome: report of 3 cases.

PURPOSE: To describe functional and anatomic results obtained by treatment with photodynamic therapy (PDT) or intravitreal bevacizumab (Avastin, Roche) in macular serous retinal detachment associated with tilted disk syndrome. METHODS: Three eyes of 3 patients with symptomatic macular serous detachment associated with tilted disc syndrome (optic disc with an oblique axis, inferonasal crescent, and inferior staphyloma) were treated. In all patients, best-corrected visual acuity (BCVA) was tested and fluorescein angiography (FA) and optical coherence tomography (OCT) were performed before and about 45 days after treatment. All patients underwent a complete ophthalmologic examination including OCT at least 6 months after treatment. The first patient was treated with one low fluence (300 mW/cm2 for 83 seconds) PDT (6 months follow-up). The second patient was treated with 3 intravitreal injections of bevacizumab 1.25 mg (33 months follow-up) and the third patient was treated with 2 low fluence PDTs at 4 months and, after 1 year, 3 intravitreal injections of bevacizumab 1.25 mg (37 months follow-up). RESULTS: Before treatment, all patients complained of visual loss and metamorphopsia. The OCT showed in the macular area a focal neurosensory detachment with foveal involvement. The FA showed in the macular area multiple focal areas of hyperfluorescence due to pigment epithelium atrophy and in the second and third patient also a hyperfluorescent pinpoint with minimal leakage. After treatment in all eyes, symptoms did not change, BCVA remained stable, and in OCT the foveal neuroretinal detachment was changeless. In FA, no noticeable variation of the hyperfluorescence areas was appreciated. In the second patient, the hyperfluorescent point remained unvaried, and the same occurred in the third patient after the first PDT, while after the second PDT a new leaking dot disappeared. CONCLUSIONS: Macular serous retinal detachment was first described in 1998 as an uncommon complication of tilted disc syndrome showing angiographic and OCT features similar to a chronic central serous chorioretinopathy. In contrast to this pathology, in our patients treatment with PDT or intravitreal bevacizumab did not succeed, probably because of a different pathogenesis of macular serous detachment. Further investigations are needed to clarify the proper therapy of this disease.

Long-term results of photodynamic therapy for subfoveal choroidal neovascularization with pathologic myopia.

PURPOSE: The purpose of our study was to determine the long-term visual and anatomic outcomes of photodynamic therapy in patients affected with choroidal neovascularization secondary to pathologic myopia. METHODS: We retrospectively evaluated 43 eyes of 43 patients. Patients with pathologic myopia were included if they had received photodynamic therapy for choroidal neovascularization involving the center of the avascular foveal zone and if they had a follow-up of at least 5 years. We included only the cases for which both of the examiners of the FAs were in agreement concerning the subfoveal localization of choroidal neovascularization. Patients treated with other therapies such as anti-vascular endothelial growth factor or steroids in the study eye were excluded. Visual acuity was measured using Early Treatment Diabetic Retinopathy Study charts. Anatomic outcome measures were the lesion size expressed as the greatest linear diameter and the chorioretinal atrophy that developed around the regressed choroidal neovascularization. RESULTS: Average visual acuity was stable during the first year, tended to be worse at 2 years, whereas it was significantly worse at 3 years and afterward, reaching a loss of nearly 3 lines at 7 years. We found that neither the number of photodynamic therapy treatments nor baseline photodynamic therapy spot size influenced change of visual acuity during follow-up. Chorioretinal atrophy around choroidal neovascularization was detected in 83% of patients at the 5-year follow-up visit. CONCLUSION: The results showed that visual acuity decreased significantly after a long follow-up period mainly because of the development of chorioretinal atrophy.

Retinal angiomatous proliferation: association with clinical and angiographic features.

AIM: It was the aim of this study to evaluate the frequency of retinal angiomatous proliferation (RAP) and its association with specific clinical and angiographic characteristics in age-related macular degeneration (AMD). METHODS: A consecutive series of 126 newly diagnosed patients with exudative AMD was reviewed retrospectively. All underwent a complete ophthalmic examination, a red-free photograph and fluorescein angiography. Most patients (85/126) underwent indocyanine green choroidal angiography (ICGA). RAP was diagnosed when a connection between the retinal vasculature and the neovascular complex was recognized angiographically. RESULTS: Out of 126 patients with recent neovascular AMD, 17 had RAP (13.5%; 95% CI 8.1-20.7). The study eye of patients with RAP had more frequent hemorrhages (88.2 vs. 59.6%; p = 0.027), hard exudates (82.4 vs. 26.6%; p < 0.001), pigment epithelium detachment (64.7 vs. 23.8%; p = 0.001) and a hot spot in ICGA (70.6 vs. 22.1%; p < 0.001) with respect to the other forms of exudative AMD. Hemorrhages were more frequently superficial, multiple and within the edge of the lesion in the RAP group. Bilateral AMD was more common in the RAP group (70.6 vs. 38.0%; p = 0.011). No statistically significant differences were found regarding sex, age and visual acuity. CONCLUSION: RAP represents a common lesion in patients with neovascular AMD referred to a tertiary care clinic. The recognition of hemorrhages, hard exudates, pigment epithelium detachment or a hot spot in ICGA can assist a correct diagnosis.