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Diagnostic Accuracy of Technology-based Eye Care Services: The Technology-based Eye Care Services Compare Trial Part I.
Maa, AY, Medert, CM, Lu, X, Janjua, R, Howell, AV, Hunt, KJ, McCord, S, Giangiacomo, A, Lynch, MG
Ophthalmology. 2020;(1):38-44
Abstract
PURPOSE Ophthalmologic telemedicine has the ability to provide eye care for patients remotely, and many countries have used screening tele-ophthalmology programs for several years. One such initiative at the Veterans Affairs (VA) Healthcare System is Technology-based Eye Care Services (TECS). The TECS services are located in primary care clinics and provide basic screening eye care, including vision, refraction, and retinal photography. Eye care providers ("readers") review the clinical data and recommend appropriate follow-up. One of the most common referrals from TECS has been for glaucoma, and this study was powered for glaucoma/glaucoma suspect detection. The current study was undertaken to identify aspects of the protocol that could be refined to enhance accuracy. DESIGN Prospective comparison between the standard TECS protocol versus a face-to-face (FTF) examination on 256 patients, all of whom had no known history of significant ocular disease. PARTICIPANTS Patients with no known ocular disease who were scheduled for an in-person eye appointment at the Atlanta VA. Patients underwent screening through the TECS protocol and received an FTF examination on the same day (gold standard). The TECS readers were masked to the results of the FTF examination. MAIN OUTCOME MEASURES Percent agreement, kappa, sensitivity, and specificity were calculated for the TECS readers' interpretations versus the FTF examination. RESULTS The TECS readers showed substantial agreement for cataract (κ ≥ 0.71) and diabetic retinopathy (κ ≥ 0.61) and moderate to substantial agreement for glaucoma/glaucoma suspect (κ ≥ 0.52) compared with an FTF examination. Age-related macular degeneration (AMD) showed moderate agreement (κ ≥ 0.34). Percent agreement with the TECS protocol was high (84.3%-98.4%) for each of the disease categories. Overall sensitivity and specificity were ≥75% and ≥55%, respectively, for any diagnosis resulting in referral. Inter-reader and intra-reader agreement was substantial for most diagnoses (κ > 0.61) with percent agreements ranging from 66% to 99%. CONCLUSIONS Our results indicate that the standard TECS protocol is accurate when compared with an FTF examination for the detection of common eye diseases. The inclusion of additional testing such as OCT could further enhance diagnostic capability.
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Treatment of exudative age-related macular degeneration with aflibercept combined with pranoprofen eye drops or nutraceutical support with omega-3: A randomized trial.
Semeraro, F, Gambicordi, E, Cancarini, A, Morescalchi, F, Costagliola, C, Russo, A
British journal of clinical pharmacology. 2019;(5):908-913
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Abstract
AIMS: The aim of this study was to determine whether a combination of intravitreal aflibercept (IVA) and pranoprofen eyedrops or nutraceutical support provides additional benefit over IVA monotherapy for the treatment of choroidal neovascularization (CNV) in age-related macular degeneration. METHODS This was a prospective, randomized, pilot study in 60 patients with treatment-naïve CNV. Patients were randomized 1:1:1 into three groups: aflibercept monotherapy (AM), aflibercept plus pranoprofen (AP) or aflibercept plus nutraceutical (AN) tablets containing multivitamin antioxidant and mineral supplementation plus omega-3. RESULTS At 12 months, all groups showed significant improvement in both best-corrected visual acuity (BCVA) and central retinal thickness (CRT). The mean BCVA change from baseline to 12 months was -0.26 ± 0.06 LogMAR, -0.30 ± 0.06 LogMAR and -0.24 ± 0.04 LogMAR in the AM, AP and AN groups, respectively. The mean CRT change from baseline to 12 months was -76.9 ± 10.9 μm, -129 ± 19.9 μm and -105 ± 11.6 μm in the AM, AP and AN groups, respectively. The AN group required one less IVA injection than the AM group. CONCLUSIONS Compared with AM, both combination groups acted synergistically, although no significant benefits in BCVA were found over AM. Nutraceutical support with omega-3 leads to a reduced need for IVA.
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Anti-platelet effects of vitamin supplements in age-related macular degeneration: an in vitro study.
Moschos, MM, Laios, K, Androudi, S, Ladas, DS, Chatziralli, IP
Cutaneous and ocular toxicology. 2018;(3):207-209
Abstract
OBJECTIVE The purpose of this experimental study was to investigate the role of vitamin supplements (Ocuvite, Vitalux Omega, and Nutrof Total) as possible inhibitors of the onset of age-related macular degeneration (AMD). MATERIALS AND METHODS The anti-aggregating effect of each vitamin was determined against four accumulative factors namely, platelet activating factor (PAF), adenosine diphosphate (ADP), thrombin receptor-activating peptide (TRAP), and arachidonic acid (AA) in the platelet rich plasma (PRP) of healthy volunteers. RESULTS Ocuvite, Vitalux Omega, and Nutrof Total were more potent inhibitors against PAF and ADP compared to TRAP and AA. Among the three vitamins, Nutrof Total displayed more potent inhibitions against TRAP and AA, while against PAF and ADP all the three vitamins revealed similar IC50 values. CONCLUSIONS The vitamins Ocuvite, Vitalux Omega, and Nutrof Total have anti-aggregating effects and therefore can be used against AMD in healthy volunteers.
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Comparative role of intravitreal ranibizumab versus bevacizumab in choroidal neovascular membrane in age-related macular degeneration.
Biswas, P, Sengupta, S, Choudhary, R, Home, S, Paul, A, Sinha, S
Indian journal of ophthalmology. 2011;(3):191-6
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CONTEXT Ranibizumab and bevacizumab are used widely for treating patients with choroidal neovascular membrane (CNVM) secondary to age-related macular degeneration (AMD). AIMS To determine and compare the efficacy and safety of intravitreal ranibizumab and bevacizumab in treatment of CNVM due to AMD. SETTINGS AND DESIGN Prospective comparative case series carried out in an eye institute and eye department of a hospital in Kolkata, India. MATERIALS AND METHODS One hundred and four eyes with CNVM due to AMD were randomized into two groups. Group A (n=54; 24 occult) received monthly intravitreal ranibizumab injections (0.5 mg in 0.05 ml) and Group B (n=50; 22 occult) received monthly bevacizumab injections (1.25 mg in 0.05 ml) for 3 consecutive months and then as per study criteria. Data analysis done using SPSS software. P-value of <0.05 was considered statistically significant. RESULTS The mean best corrected visual acuity (BCVA) in the ranibizumab group increased from 58.19 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at baseline to 64 ETDRS letters at month 3 (P<0.001). In bevacizumab group mean BCVA increased from 56.80 to 61.72 ETDRS letters at month 3 (P<0.001). At the end of 18 months, there was no statistically significant difference between groups A and B with respect to change in BCVA (P=0.563) or central macular thickness (CMT; P=0.281), as measured by optical coherence tomography (Stratus OCT 3000). No significant sight-threatening complications developed. CONCLUSIONS Ranibizumab and bevacizumab are equally safe and efficacious in treating CNVM due to AMD.
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Quantitative analysis of central visual field defects in macular edema using three-dimensional computer-automated threshold Amsler grid testing.
Jivrajka, RV, Kim, JK, Fink, W, Sadun, AA, Sebag, J
Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie. 2009;(2):165-70
Abstract
PURPOSE To evaluate the central visual field (CVF) with specialized Amsler grid testing methods that include contrast sensitivity evaluation, in an attempt to detect abnormalities not identified with standard methods and to define new patterns of CVF deficits in two different diseases. METHODS 3D computer-automated threshold Amsler grid testing (3D-CTAG) was performed at five levels of contrast in one eye of 37 patients with diabetic macular edema (DME, n = 16) and exudative age-related macular degeneration (AMD, n = 21). RESULTS 3D-CTAG abnormalities were detected in six patients (16%) who had no abnormalities with conventional Amsler grid testing. DME patients had more foci of CVF deficits (3.56 +/- 2.92 defects/eye), than AMD patients (1.24 +/- 0.89 defects/eye; P < 0.0002). The shape of the 3D-CTAG abnormality in DME was an inverted cone, while the deficits in AMD were always cylindrical. All eyes showed significant increases in CVF deficit surface area at minimum contrast levels when compared to maximum contrast (295% greater with DME, P < 0.02 and 150% greater with AMD, P < 0.03). CONCLUSION 3D-CTAG detected CVF abnormalities not identified with conventional Amsler grid testing in 16% of subjects. Low-contrast conditions elicited a larger defect in both DME (3-fold) and AMD (1.5-fold). DME and AMD have unique 3D-CTAG profiles, enabling diagnostic discrimination. Measuring CVF defects with 3D-CTAG can quantitatively index disease severity and may be useful in longitudinal studies of the natural history of disease, as well as providing a quantitative outcome measure of the response to therapy.
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Optical coherence tomography analysis of a randomized study combining photodynamic therapy with intravitreal triamcinolone.
Arias, L, Garcia-Arumi, J, Ramon, JM, Badia, M, Rubio, M, Pujol, O
Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie. 2008;(2):245-54
Abstract
BACKGROUND The objective of the study was to analyze optical coherence tomography (OCT) scan differences between patients with predominantly classic subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) treated with only photodynamic therapy (PDT) and patients treated with PDT combined with intravitreal triamcinolone acetonide (IVTA). METHODS In this prospective study, 61 patients were randomized to receive PDT (n = 30) or PDT combined with IVTA (n = 31). They were evaluated every 3 months with a refraction protocol for best-corrected visual acuity (VA) measured with Early Treatment Diabetic Retinopathy Study (ETDRS) charts, fluorescein angiography (FA), and OCT. When measuring foveal thickness on OCT scans, neuroretinal foveal thickness (NFT) was differentiated from outer high reflectivity band thickness (OHRBT). The main outcome measures were mean change in OCT measurements and correlation of VA and angiographic area of the lesion with OCT measurements. RESULTS At the 12-month follow-up, the mean change in NFT was not significantly reduced (P = 0.9), but the mean change in OHRBT was significantly lower (P = 0.004) in the group of patients who received combined therapy. There was no correlation between final VA and NFT in either patient group (P = 0.2). The final VA was significantly worse in eyes with a thicker OHRBT (P = 0.04) in the group of patients treated with only PDT. There was no correlation between angiographic area and NFT and OHRBT in either patient group (P > 0.3). There was a statistically significant difference between the pre-treatment angiographic area of the lesion and VA at the 12-month follow-up in the combined therapy group (P = 0.01), and more eyes treated with only PDT presented with intraretinal fluid at the last follow-up (P = 0.01). CONCLUSION Combined PDT+IVTA therapy was more effective than PDT alone at reducing OHRBT. This OCT measurement seems to be have a greater effect on VA than NFT.
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Effect of adjunctive diclofenac with verteporfin therapy to treat choroidal neovascularization due to age-related macular degeneration: phase II study.
, , Boyer, DS, Beer, PM, Joffe, L, Koester, JM, Marx, JL, Weisberger, A, Yoser, SL
Retina (Philadelphia, Pa.). 2007;(6):693-700
Abstract
BACKGROUND To determine short-term effects of topical diclofenac administered in conjunction with verteporfin therapy for predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD). METHODS Randomized, multicenter (14), prospective, placebo-controlled, double-masked clinical trial. Patients (n=61) were randomly assigned to treatment with diclofenac sodium ophthalmic solution 0.1% or placebo and followed for 12 weeks. Patients instilled diclofenac or placebo two drops four times daily, 2-4 days before verteporfin treatment until 2 weeks after treatment, then two drops twice daily for 10 weeks. This exploratory study was not powered to detect differences between treatment groups. Statistical analyses were conducted solely to aid interpretation of results. RESULTS In diclofenac-treated eyes, mean changes in visual acuity letter score from baseline in the diclofenac and placebo groups were +1.8 letters and -1.0 at week 1 (P=0.505 between groups). Mean visual acuity letter scores decreased in both groups at all subsequent visits, with a mean change at 12 weeks of -7.4 with diclofenac and -2.6 with placebo (P=0.213). Percentages of eyes with stable or improved vision (change or=5 letters) were similar in the diclofenac and placebo groups at all study visits. No significant between-group differences in changes from baseline in lesion area, greatest linear dimension (GLD), fluorescein leakage, or retinal thickness were detected. CONCLUSION In patients with predominantly classic subfoveal CNV due to AMD, administration of topical diclofenac with verteporfin therapy was associated with similar vision outcomes to placebo plus verteporfin therapy.
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Improvement of visual functions and fundus alterations in early age-related macular degeneration treated with a combination of acetyl-L-carnitine, n-3 fatty acids, and coenzyme Q10.
Feher, J, Kovacs, B, Kovacs, I, Schveoller, M, Papale, A, Balacco Gabrieli, C
Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde. 2005;(3):154-66
Abstract
The aim of this randomized, double-blind, placebo-controlled clinical trial was to determine the efficacy of a combination of acetyl-L-carnitine, n-3 fatty acids, and coenzyme Q10 (Phototrop) on the visual functions and fundus alterations in early age-related macular degeneration (AMD). One hundred and six patients with a clinical diagnosis of early AMD were randomized to the treated or control groups. The primary efficacy variable was the change in the visual field mean defect (VFMD) from baseline to 12 months of treatment, with secondary efficacy parameters: visual acuity (Snellen chart and ETDRS chart), foveal sensitivity as measured by perimetry, and fundus alterations as evaluated according to the criteria of the International Classification and Grading System for AMD. The mean change in all four parameters of visual functions showed significant improvement in the treated group by the end of the study period. In addition, in the treated group only 1 out of 48 cases (2%) while in the placebo group 9 out of 53 (17%) showed clinically significant (>2.0 dB) worsening in VFMD (p = 0.006, odds ratio: 10.93). Decrease in drusen-covered area of treated eyes was also statistically significant as compared to placebo when either the most affected eyes (p = 0.045) or the less affected eyes (p = 0.017) were considered. These findings strongly suggested that an appropriate combination of compounds which affect mitochondrial lipid metabolism, may improve and subsequently stabilize visual functions, and it may also improve fundus alterations in patients affected by early AMD.
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[Surgical treatment of diabetic retinopathy and maculopathy].
Joussen, AM, Llacer, H, Mazciewicz, J, Kirchhof, B
Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft. 2004;(12):1171-80
Abstract
Surgical therapy of diabetic retinopathy has been refined since the Early Treatment Diabetic Retinopathy Study (ETDRS). ETDRS did not perform panretinal photocoagulation at the time of surgery, which is currently considered a major part of vitrectomy, e.g., in vitreous hemorrhage. Despite improved surgical techniques, patient expectations and surgical outcome still differ considerably in severe cases of proliferative diabetic retinopathy. In this review of the literature we discuss the current surgical options and indications in diabetic retinopathy and maculopathy.