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Effect of Face-Down Positioning vs Support-the-Break Positioning After Macula-Involving Retinal Detachment Repair: The PostRD Randomized Clinical Trial.
Casswell, EJ, Yorston, D, Lee, E, Heeren, TFC, Harris, N, Zvobgo, TM, Tarafdar, S, Xing, W, Bourmpaki, E, Bunce, C, et al
JAMA ophthalmology. 2020;(6):634-642
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Abstract
IMPORTANCE A lack of consensus exists with regard to the optimal positioning regimen for patients after macula-involving retinal detachment (RD) repair. OBJECTIVE To evaluate the effect of face-down positioning vs support-the-break positioning on retinal displacement and distortion after macula-involving RD repair. DESIGN, SETTING, AND PARTICIPANTS A prospective 6-month single-masked randomized clinical trial was conducted at a multicenter tertiary referral setting from May 16, 2016, to May 1, 2018. Inclusion criteria were fovea-involving rhegmatogenous RD; central visual loss within 14 days; patients undergoing primary vitrectomy and gas surgery, under local anesthetic; patients able to give written informed consent; and 18 years old and older. Analysis was conducted following a modified intention-to-treat principle, with patients experiencing a redetachment or failure to attach the macula being excluded from analysis. INTERVENTIONS Participants were randomized 1:1 to receive face-down positioning or support-the-break positioning for a 24-hour period postoperatively. Positioning compliance was not monitored. MAIN OUTCOMES AND MEASURES The proportion of patients with retinal displacement on autofluorescence imaging at 6 months postoperatively. Secondary outcomes included proportion of patients with displacement at 2 months; amplitude of displacement at 2 and 6 months; corrected Early Treatment Diabetic Retinopathy Study visual acuity; objective Distortion Scores; and quality of life questionnaire scores at 6 months. RESULTS Of the 262 randomized patients, 239 were analyzed (171 male [71.5%]; mean [SD] age, 60.8 [9.8] years). At 6 months, retinal displacement was detected in 42 of 100 (42%) in the face-down positioning group vs 58 of 103 (56%) in the support-the-break positioning group (odds ratio, 1.77; 95%CI, 1.01-3.11; P = .04). The degree of displacement was lower in the face-down group. Groups were similar in corrected visual acuity (face-down, 74 letters vs support-the-break, 75 letters), objective D Chart Distortion Scores (range: 0, no distortion to 41.6, severe distortion; with face-down at 4.5 vs support-the-break at 4.2), and quality of life scores (face-down 89.3 vs support-the-break 89.0) at 2 and 6 months. Retinal redetachment rate was similar in both groups (face-down group, 12.2% and support-the-break group, 13.7%). Retinal folds were less common in the face-down positioning group vs the support-the-break positioning group (5.3% vs 13.5%, respectively; odds ratio, 2.8; 95% CI, 1.2-7.4; P = .03). Binocular diplopia was more common in the support-the-break group compared with the face-down positioning group (7.6% vs 1.5%, respectively; odds ratio, 5.3; 95% CI, 1.3-24.6; P = .03). Amplitude of displacement was associated with worse visual acuity (r = -0.5; P < .001) and distortion (r = 0.28; P = .008). CONCLUSIONS AND RELEVANCE In this study, findings suggest that face-down positioning was associated with a reduction in the rate and amplitude of postoperative retinal displacement after macula-involving RD repair and with a reduction in binocular diplopia. No association was found with visual acuity or postoperative distortion. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02748538.
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Effects of kallidinogenase in patients undergoing vitrectomy for diabetic macular edema.
Yoshizumi, Y, Ohara, Z, Tabuchi, H, Sumino, H, Maeda, Y, Mochizuki, H, Yamane, K, Kiuchi, Y
International ophthalmology. 2019;(6):1307-1313
Abstract
PURPOSE To evaluate the effectiveness of the combination of vitrectomy with kallidinogenase for diabetic macular edema (DME). METHODS This study was designed as a prospective, randomized, multicenter study comparing 19 eyes of 19 patients who received 150 units of kallidinogenase administered a day for 52 weeks from the day after vitrectomy (study group) with 20 eyes of 20 patients who received no kallidinogenase (control group). The main outcome measurements included logMAR visual acuity and central foveal thickness (CFT) before surgery and at 3, 6, 9, and 12 months after vitrectomy. RESULTS During follow-up, 11 patients dropped out (six in the study group and five in the control group), leaving 28 eyes in 28 patients for analysis (13 in the study group and 15 in the control group). Visual acuity improved significantly at 12 months in both groups compared with before surgery. The degree of improvement did not differ significantly between the groups. At 12 months, the mean CFT decreased significantly in both groups, with no significant difference in the rate of change between the two groups. In the study group, the visual acuity and CFT significantly improved from 3 to 12 months and from 6 to 12 months, whereas these parameters did not continue to improve in the control group after 6 months (for visual acuity) or 3 months (for CFT). CONCLUSION After vitrectomy for DME, visual acuity and CFT improved significantly in both groups, but only patients treated with kallidinogenase continued to have significant improvement throughout the study period.
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Effect of intravitreal triamcinolone acetonide injection at the end of vitrectomy for vitreous haemorrhage related to proliferative diabetic retinopathy.
Takamura, Y, Shimura, M, Katome, T, Someya, H, Sugimoto, M, Hirano, T, Sakamoto, T, Gozawa, M, Matsumura, T, Inatani, M, et al
The British journal of ophthalmology. 2018;(10):1351-1357
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Abstract
BACKGROUND/AIMS: To investigate whether intravitreal injection of triamcinolone acetonide (IVTA) combined with vitrectomy prevents postoperative inflammation in patients with vitreous haemorrhage (VH) due to proliferative diabetic retinopathy (PDR). METHODS This prospective, multicentre, randomised study conducted at seven sites in Japan enrolled patients diagnosed as having VH following PDR. Patients underwent vitrectomy with (IVTA+VIT group) or without (VIT group) IVTA at the end of the surgery. Anterior flare intensity (AFI), central retinal thickness (CRT), best-corrected visual acuity (BCVA) and intraocular pressure (IOP) were measured before and at 3 days, 1 week, 1, 3 and 6 months after surgery and compared. RESULTS Number of patients who completed 6 months of follow-up was 40 and 41 in VIT group and IVTA+VIT group, respectively. AFI was significantly higher in the VIT group than in the IVTA+VIT group at 3 days (P=0.033), 1 week (P=0.019) and 1 month (P=0.037). There were no significant differences in CRT, BCVA and IOP between the groups through the observational periods. In the cases with macular oedema >350 µm of CRT at 3 days, CRT was significantly lower in the IVTA+VIT group than in the VIT group at 1 month (P=0.041). CONCLUSIONS IVTA combined with vitrectomy and cataract surgery contributed to inhibit the postoperative inflammation in patients with VH due to PDR. The effect of IVTA in the reduction of diabetic macular oedema may be limited to the early stage after surgery. TRIAL REGISTRATION NUMBER UMIN000020376, Post-results.
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Early versus delayed intravitreal betamethasone as an adjuvant in the treatment of presumed postoperative endophthalmitis: a randomised trial.
Koehrer, P, Bron, AM, Chiquet, C, Thuret, G, Delbosc, B, Berrod, JP, Bourcier, T, Sauer, A, Jonval, L, D'Athis, P, et al
The British journal of ophthalmology. 2016;(8):1076-80
Abstract
AIM: To compare early versus delayed intravitreal betamethasone as an adjuvant in the treatment of presumed acute postoperative endophthalmitis after phacoemulsification. METHODS Patients with presumed postcataract surgery endophthalmitis were included in this prospective, randomised, multicentre study. On admission, patients received intravitreal vancomycin and ceftazidime, and were randomly assigned to intravitreal betamethasone injection (early-IVB) group or no immediate injection (delayed-IVB) group. After 48 h, a second intravitreal antibiotic injection associated with intravitreal betamethasone was given to all patients. In patients with severe endophthalmitis or clinical deterioration, a prompt or delayed vitrectomy was performed. The primary outcome was the proportion of patients achieving a visual acuity (VA) of 20/40 or better at 12 months. The secondary outcomes were the rate of delayed vitrectomy and the rate of complications (retinal detachment and phthisis). RESULTS Ninety-seven eyes of 97 patients were included, 45 in the early-IVB group and 52 in the delayed-IVB group. Overall, 62.9% of patients achieved a VA ≥20/40 at 1 year. There was no statistically significant difference in the visual outcome between the two groups at 1 year, whatever their baseline VA or light perception or hand motion or more (p=0.55 and p=0.10, respectively). The rates of delayed vitrectomy, retinal detachment and phthisis bulbi were not significantly different between the two groups (p=0.42, p=0.37 and p=0.44, respectively). CONCLUSIONS Early intravitreal betamethasone had no clear advantage versus delayed injection in the management of presumed postoperative endophthalmitis.
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One-year results of a multicenter controlled clinical trial of triamcinolone in pars plana vitrectomy.
Yamakiri, K, Sakamoto, T, Noda, Y, Nakahara, M, Ogino, N, Kubota, T, Yokoyama, M, Furukawa, M, Ishibashi, T
Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie. 2008;(7):959-66
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Abstract
PURPOSE To evaluate the 1-year results of using triamcinolone acetonide (TA) in pars plana vitrectomy (PPV). DESIGN Multicenter prospective controlled clinical trial. SETTING AND STUDY POPULATION the study population comprised 774 eyes from patients treated at eight Japanese hospitals, among which 391 eyes underwent TA-assisted PPV and 383 control eyes underwent conventional PPV. The patients were assigned to the two groups using a single-blind quasi-randomization approach within the participating clinical centers. INTERVENTION intra-operative use of TA to aid visualization of the vitreous. MAIN OUTCOME MEASURES changes of visual acuity, post-operative complications (including additional surgery), and adverse events occurring within 1 year of the operation were compared between the TA-PPV group and the conventional PPV group. RESULTS The visual acuity improved over time, and no significant differences were found between the two groups (log-rank versus TA, P = 0.98 for improvement, P = 0.26 for deterioration). The logistic regression model also showed that the intra-operative use of TA was not a significant factor for the improvement of visual acuity [P = 0.91, odds ratio (OR) = 1.10, 95% confidence interval (95%CI) = 0.860-1.183)] after adjustments for age, gender, and diagnosis. Intra-operative TA was not a significant factor for the need for additional surgery (log-rank test P = 0.45, logistic regression test P = 0.35, OR = 1.23, 95%CI = 0.797-1.911]. No serious adverse events related to surgery were observed. CONCLUSIONS This 1-year follow-up study of a controlled clinical trial showed that TA-assisted PPV had neither a positive nor a negative effect on visual acuity, the incidence of additional surgeries, or adverse events compared with conventional PPV.
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Reduced incidence of intraoperative complications in a multicenter controlled clinical trial of triamcinolone in vitrectomy.
Yamakiri, K, Sakamoto, T, Noda, Y, Nakahara, M, Ogino, N, Kubota, T, Yokoyama, M, Furukawa, M, Sonoda, Y, Yamada, T, et al
Ophthalmology. 2007;(2):289-96
Abstract
PURPOSE To evaluate the benefits and potential complications of using triamcinolone acetonide (TA) in pars plana vitrectomy (PPV). DESIGN Multicenter, prospective, controlled clinical trial. PARTICIPANTS In total, 774 patients from 8 Japanese hospitals were enrolled, with 391 patients undergoing TA-assisted PPV and 383 control patients undergoing conventional PPV. INTERVENTION Intraoperative use of TA to aid visualization of the vitreous. MAIN OUTCOME MEASURES The incidence of intraoperative complications, including retinal breaks, was evaluated. Early postoperative complications, intraocular pressure (IOP), and adverse events occurring within 3 months of the operation were also monitored. RESULTS The incidence of both retinal breaks and intraoperative retinal detachment was significantly lower in TA-assisted PPV than in conventional PPV. Retinal breaks were seen in 34 eyes (8.7%) undergoing TA-assisted PPV compared with 54 eyes (14.1%) undergoing conventional PPV (odds ratio [OR], 0.603; 95% confidence interval [CI], 0.381-0.955; P = 0.031). Retinal detachment was seen in only 3 eyes (0.8%) in which TA was used compared with 14 eyes (3.7%) in which TA was not used (OR, 0.204; 95% CI, 0.057-0.727; P = 0.014). In total, 388 eyes in the TA-assisted PPV group (99.2%) and 374 eyes in the conventional PPV group (97.6%) were followed up for 3 months after the operation. Although the mean postoperative IOPs were comparable in both groups, antiglaucoma eye drops were used more frequently by patients in the TA-assisted group than by those in the conventional PPV group (OR, 1.673; 95% CI, 1.126-2.484; P = 0.011). No serious adverse events, such as endophthalmitis or retinal degeneration, were observed in either group. CONCLUSIONS Intraoperative use of TA reduced the incidence of retinal breaks and retinal detachments in eyes undergoing PPV. There were no serious adverse events related to the intraoperative use of TA. Although antiglaucoma eye drops were required more frequently after TA-assisted PPV than after conventional PPV, IOP was well-controlled in both groups.
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Topical anesthesia in posterior vitrectomy.
Yepez, J, Cedeño de Yepez, J, Arevalo, JF
Retina (Philadelphia, Pa.). 2000;(1):41-5
Abstract
PURPOSE To evaluate the efficacy of topical anesthesia as an alternative to peribulbar or retrobulbar anesthesia in posterior vitrectomy procedures. METHODS Posterior vitrectomy using topical anesthesia (4% lidocaine drops) was performed prospectively in 134 eyes (134 patients) with various vitreoretinal diseases, including severe proliferative diabetic retinopathy (n = 69), vitreous hemorrhage (n = 12), rhegmatogenous retinal detachments (n = 11), epiretinal membranes (n = 10), macular holes (n = 7), dislocated crystalline lens or intraocular lens (n = 6), giant retinal tears (n = 5), intraocular foreign bodies (n = 3), trauma (n = 3), endophthalmitis (n = 3), subfoveal choroidal neovascular membrane (n = 3), and neovascular glaucoma (n = 2). In 26 (19.4%) eyes, posterior vitrectomy was combined with a scleral buckling procedure, and in 84 (62.6%) eyes, argon laser photocoagulation was performed. Preoperative and intraoperative sedation of varying degrees was necessary. Subjective pain and discomfort were graded from 1 (no pain or discomfort) to 4 (severe pain and discomfort). RESULTS All patients had grade 1 pain and discomfort during most of the procedure. All patients had grade 2 (mild) pain and discomfort during pars plana sclerotomies, external bipolar cautery, and conjunctival closure. The average amount of 4% lidocaine drops needed during each procedure was 0.5 mL. No patient required additional retrobulbar, peribulbar, or sub-Tenon anesthesia. CONCLUSIONS This technique avoids the risk of globe perforation, retrobulbar hemorrhage, and prolonged postoperative akinesia of the eye. With appropriate case selection, topical anesthesia is a safe and effective alternative to peribulbar or retrobulbar anesthesia in three-port pars plana vitrectomy procedures.