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Systemic oxygen therapy versus oral enalapril for treatment of diabetic macular ischemia: a randomized controlled trial.
Sharifipour, F, Razzaghi, M, Ramezani, A, Azarmina, M, Yaseri, M, Soheilian, R, Soheilian, M
International ophthalmology. 2016;(2):225-35
Abstract
The purpose of this study was to evaluate the structural and functional effects of systemic oxygen therapy and enalapril in patients with diabetic macular ischemia (DMI). This randomized clinical trial consisted of 105 eyes with DMI divided into three groups. Group I received systemic oxygen by face mask at a flow rate of 10 L/min; Group II received 5 mg enalapril daily; and Group III received placebo tablets for 3 months. Best-corrected visual acuity (BCVA), central macular thickness (CMT) measured by optical coherence tomography (OCT), extent of foveal avascular zone (FAZ) on fluorescein angiograms, and electroretinograms (ERG) were obtained at baseline and after 3 and 6 months. Overall, 102 patients completed the study. Baseline characteristics were not significantly different among groups. Significant improvement in BCVA and decrease in CMT and FAZ occurred at months 3 and 6 in oxygen group compared to deterioration in enalapril and control groups (All P values <0.001). ERG parameters were significantly better in oxygen group compared to enalapril group at months 3 and 6 and better than those in control group at month 3. Normobaric oxygen therapy for 3 months in DMI decreased CMT and FAZ and improved BCVA and ERG parameters. Enalapril did not show any favorable effect.
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Screening in Primary Care for Diabetic Retinopathy, Maculopathy and Visual Loss in South Africa.
Webb, EM, Rheeder, P, Roux, P
Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde. 2016;(3):141-9
Abstract
OBJECTIVE The aim of the study was to determine the prevalence of diabetic retinopathy, maculopathy and visual loss in primary care patients and to identify associated risk factors. RESEARCH DESIGN AND METHODS We conducted a cluster randomised trial at primary care clinics in the Tshwane district in South Africa. Grades of retinopathy and maculopathy (with fundus camera) and visual acuity (Snellen chart) were assessed and, using mobile screening and teleophthalmology, clinical and biochemical testing was conducted to obtain information about glycaemic control and microvascular complications. RESULTS The prevalence rates for any retinopathy, preproliferative retinopathy and proliferative retinopathy were 24.9, 19.5 and 5.5%, respectively. The prevalence rates of diabetic maculopathy, observable maculopathy and referable maculopathy were 20.8, 11.8 and 9.0%, respectively. The presence of retinopathy was associated with high body mass index, systolic blood pressure, being on insulin treatment, high HbA1c and the presence of neuropathy. High systolic blood pressure, being on insulin treatment, high HbA1c level and high low-density lipoprotein cholesterol level as well as the presence of albuminuria were significant in predicting any diabetic maculopathy. Laser photocoagulation was given to 8.3% of patients from the mobile unit and 12% of patients were referred to the nearest hospital with an outpatient eye clinic for follow-up treatment of various other eye conditions. Using the WHO categories, the study found that 78.1% of diabetes patients had normal vision, 19.3% were visually impaired and 2.2% were severely impaired or blind. CONCLUSION High prevalence rates for diabetic retinopathy, maculopathy and visual loss were found and associations were identified.
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Effect of Vitreomacular Adhesion on Treatment Outcomes in the Ranibizumab for Edema of the Macula in Diabetes (READ-3) Study.
Sadiq, MA, Soliman, MK, Sarwar, S, Agarwal, A, Hanout, M, Demirel, S, Rentiya, ZS, Khan, W, Do, DV, Nguyen, QD, et al
Ophthalmology. 2016;(2):324-329
Abstract
PURPOSE To assess the role of vitreomacular adhesion (VMA) in visual and anatomic outcomes in patients with diabetic macular edema (DME). DESIGN Retrospective cohort study. PARTICIPANTS Data from patients enrolled in the Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 with High Dose (READ-3) study were analyzed. METHODS In the READ-3 study, patients with DME received monthly intravitreal injections of either 0.5 or 2.0 mg ranibizumab. Optical coherence tomography images from patients who completed the month 6 visit of the study were analyzed at the baseline visit to identify the presence (VMA+) or absence (VMA-) of VMA. Patients with any degree of vitreomacular traction were excluded from the analysis. Two independent graders graded all images. Vitreomacular adhesion was classified by size of adhesion into either focal (<1500 μm) or broad (≥1500 μm). MAIN OUTCOME MEASURES Mean changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) at month 6 and incidence of posterior vitreous detachment (PVD). RESULTS One hundred fifty-two eyes (152 patients) were randomized in the READ-3 study. One hundred twenty-four eyes (124 patients) were eligible for the study based on study criteria. Twenty-eight eyes did not meet study criteria and were excluded from the study. At baseline, 26 patients were classified as VMA+ and 98 patients were classified as VMA-. The distribution of the 2 doses of ranibizumab (0.5 and 2.0 mg) in the 2 groups was similar. At month 6, the mean improvement in BCVA was 11.31±6.67 and 6.86±7.58 letters in the VMA+ and VMA- groups, respectively (P = 0.007). Mean improvement in CRT was -173.81±132.31 and -161.84±131.34 μm in the VMA+ and VMA- groups, respectively (P = 0.681). At month 6, among the 26 VMA+ eyes (at baseline), 7 eyes demonstrated PVD, 17 eyes showed no change in VMA status, and 2 eyes were not gradable and were excluded. CONCLUSIONS Diabetic macular edema patients with VMA have a greater potential for improvement in visual outcomes with anti-vascular endothelial growth factor therapy. Therefore, the presence of VMA should not preclude patients with DME from receiving treatment.
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Ophthalmologic complications in children with chronic hepatitis C treated with pegylated interferon.
Narkewicz, MR, Rosenthal, P, Schwarz, KB, Drack, A, Margolis, T, Repka, MX, ,
Journal of pediatric gastroenterology and nutrition. 2010;(2):183-6
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Abstract
OBJECTIVES Interferon treatment for chronic viral hepatitis C (HCV) has been associated with the development of retinopathy in 19% to 29% of adults. Our purpose is to describe the ophthalmologic complications of pegylated interferon-alpha2a with either placebo or ribavirin in children with chronic HCV (the PEDS-C trial). MATERIALS AND METHODS Prospective, comprehensive ophthalmologic examinations including slit lamp at enrollment and after 24 and 48 weeks of treatment of 114 children participating in a randomized clinical trial. RESULTS One hundred and twenty-eight children were screened for entry, of whom 123 had an eye examination and no child had existing retinal disease. One hundred fourteen children were eligible and were treated. One hundred ten children had an eye examination at 24 weeks and 103 children at 48 weeks. Three of 114 subjects (2.6%) developed documented (n = 2) or possible (1) serious eye complications. One subject developed evidence of ischemic retinopathy (cotton-wool spots) by week 24, 1 developed uveitis by week 48, and 1 reported at week 48 transient (<4 hours) monocular blindness that had occurred at week 36 with a subsequent normal examination at week 48. CONCLUSIONS Ophthalmologic complications are infrequent in children who are treated with pegylated interferon-alpha2a for HCV (2%-3%). Because of the potential severity of ischemic retinopathy and uveitis, prospective ocular assessment should remain part of the monitoring strategy for children who are treated with interferon for HCV.
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Topical ketorolac in vitreoretinal surgery: a prospective, randomized, placebo-controlled, double-masked trial.
Kim, SJ, Lo, WR, Hubbard, GB, Srivastava, SK, Denny, JP, Martin, DF, Yan, J, Bergstrom, CS, Cribbs, BE, Schwent, BJ, et al
Archives of ophthalmology (Chicago, Ill. : 1960). 2008;(9):1203-8
Abstract
OBJECTIVE To evaluate the effects of topical ketorolac in patients undergoing vitreoretinal surgery. METHODS One hundred nine patients undergoing vitrectomies were randomized to receive either topical ketorolac tromethamine, 0.4%, or placebo. Patients were instructed to begin taking the study medication 3 days preoperatively (4 times daily) and to continue taking it 4 weeks postoperatively. MAIN OUTCOME MEASURES Intraoperative pupil diameter, postoperative day 1 pain and inflammation, 1-month postoperative retinal thickness, and preoperative and 1-month postoperative best-corrected visual acuities. RESULTS The difference in mean pupil diameters between patients using ketorolac and those taking placebo was 0.06 mm (P = .39). Patients taking ketorolac and those taking placebo had mean pain scores (scale, 1-10) of 0.24 (SD, 0.6) and 1.06 (SD, 2) (P = .03) and mean inflammation grades (grade, 0-4) of 0.59 (SD, 0.7) and 1.16 (SD, 0.9) (P < .001), respectively. Ketorolac reduced central subfield thickness by 8%, but this was not statistically significant. At 1 month, mean visual acuities improved to 0.40 logMAR units (mean Snellen, 20/50; SD, 0.28 logMAR units) in the ketorolac group from 0.83 logMAR units (20/150(+2); SD, 0.60 logMAR units) at baseline and to 0.67 logMAR units (20/100(+1); SD, 0.46 logMAR units) in the placebo group from 0.92 logMAR units (20/150(-2); SD, 0.62 logMAR units) at baseline (P = .001). CONCLUSIONS Topical ketorolac was well tolerated and safe, reduced postoperative pain and inflammation, and improved visual recovery in this prospective, double-masked trial. APPLICATION TO CLINICAL PRACTICE Topical ketorolac may benefit patients undergoing vitreoretinal surgery. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00576329.
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Treatment of vascular retinopathies with Pycnogenol.
Spadea, L, Balestrazzi, E
Phytotherapy research : PTR. 2001;(3):219-23
Abstract
The aim of our study was to investigate the effects of Pycnogenol on the progression of diabetic retinopathy and other vascular retinal disorders. The study consisted of a double-blind phase in which 20 patients were recruited and randomly treated with placebo or Pycnogenol (50 mg x 3/day for 2 months) and an open phase in which another 20 patients were treated with Pycnogenol at the same dose schedule. In total, 40 patients with diabetes, atherosclerosis and other vascular diseases involving the retina were enrolled; 30 of them were treated with Pycnogenol and 10 with placebo. The results demonstrated a beneficial effect of Pycnogenol on the progression of retinopathy. Without any treatment (placebo) the retinopathy progressively worsened during the trial and the visual acuity significantly decreased; on the contrary, the Pycnogenol-treated patients showed no deterioration of retinal function and a significant recovery of visual acuity was also obtained. The fluorangiography showed an improvement of retinal vascularization and a reduced endothelial permeability and leakage in the Pycnogenol, but not in the placebo-treated, patients. The ophthalmoscopy and the electroretinogram (ERG) also confirmed the beneficial effects of Pycnogenol. The mechanism of action of Pycnogenol may be related to its free radical (FR) scavenging, anti-inflammatory and capillary protective activities. It has been suggested that Pycnogenol may bind to the blood vessel wall proteins and mucopolysaccharides and produce a capillary 'sealing' effect, leading to a reduced capillary permeability and oedema formation.