-
1.
SILICONE OIL VERSUS PERFLUOROPROPANE GAS TAMPONADE DURING VITRECTOMY FOR TRACTIONAL RETINAL DETACHMENT OR FIBROUS PROLIFERATION: A Randomized Clinical Trial.
Rush, RB, Del Valle Penella, A, Reinauer, RM, Rush, SW, Bastar, PG
Retina (Philadelphia, Pa.). 2021;(7):1407-1415
Abstract
PURPOSE To compare vitreous substitution with silicone oil to perfluoropropane gas in proliferative diabetic retinopathy subjects undergoing pars plana vitrectomy (PPV) for the treatment of tractional retinal detachment or extensive fibrous proliferation. DESIGN Randomized clinical trial. METHODS Three hundred and two proliferative diabetic retinopathy subjects with tractional retinal detachment or extensive fibrous proliferation requiring PPV were enrolled into the trial. Subjects were prospectively randomized into one of two vitreous substitution groups during PPV: Group A subjects underwent 1,000 centistoke silicone oil tamponade, whereas Group B subjects underwent 14% to 16% silicone oil to perfluoropropane gas tamponade. The principal outcome was the best-corrected visual acuity at 6-month follow-up. Secondary outcomes were postoperative complications and unplanned PPV during the 6-month trial interval. RESULTS Two hundred and fifty-eight subjects were randomized to receive a vitreous substitute and completed 6-month follow-up. Group B had better best-corrected visual acuity, more subjects ending up with 0.4 logarithm of the minimum angle of resolution (20/50) or better visual acuity, and more subjects ending up with 1 logarithm of the minimum angle of resolution (20/200) or better visual acuity at 6 months compared with Group A (P < 0.001, P = 0.02, P < 0.001, respectively). There were no significant differences in baseline characteristics, intraoperative or postoperative complications, or incidence of unplanned PPV between groups. CONCLUSION This trial demonstrated that vitreous substitution with silicone oil to perfluoropropane gas resulted in better visual acuity at 6 months compared with silicone oil tamponade in proliferative diabetic retinopathy patients undergoing PPV for tractional retinal detachment or extensive fibrous proliferation. Surgeons should consider silicone oil to perfluoropropane gas tamponade as the first-line vitreous substitute in this patient population.
-
2.
INTERNAL LIMITING MEMBRANE PEELING DURING VITRECTOMY FOR DIABETIC VITREOUS HEMORRHAGE: A Randomized Clinical Trial.
Rush, RB, Del Valle Penella, A, Reinauer, RM, Rush, SW, Bastar, PG
Retina (Philadelphia, Pa.). 2021;(5):1118-1126
Abstract
PURPOSE To evaluate the benefits of internal limiting membrane peeling in proliferative diabetic retinopathy subjects undergoing pars plana vitrectomy for the treatment of vitreous hemorrhage. METHODS Two hundred and fifty-eight proliferative diabetic retinopathy subjects undergoing pars plana vitrectomy for vitreous hemorrhage were enrolled into the trial. Patients were randomized into one of two cohorts: Group A patients underwent internal limiting membrane peeling, whereas Group B patients did not undergo internal limiting membrane peeling. The main outcome was best-corrected visual acuity at 6 months. Secondary outcomes were optical coherence tomography central macular thickness at 6 months, incidence of diabetic macular edema treatment during the postoperative trial period, and incidence of epiretinal membrane at 6 months. RESULTS Two hundred and seven patients were randomized and completed 6 months follow-up. Group A had better best-corrected visual acuity at 6 months than Group B (P < 0.01). Group A had a lower incidence of diabetic macular edema treatment during the postoperative trial period and a lower incidence of epiretinal membrane at 6 months than Group B (P = 0.02 and P < 0.001, respectively). There was a trend toward lower central macular thickness on optical coherence tomography in Group A than Group B (P = 0.09). There were no significant differences in baseline details or complications intraoperatively or postoperatively between cohorts. CONCLUSION This trial demonstrated better vision, fewer postoperative diabetic macular edema treatments, and a lower incidence of epiretinal membrane at 6 months when internal limiting membrane peeling was performed. Internal limiting membrane peeling may be considered a vital maneuver to perform in proliferative diabetic retinopathy subjects undergoing pars plana vitrectomy for vitreous hemorrhage.
-
3.
Comparison of macular buckling and vitrectomy for the treatment of macular schisis and associated macular detachment in high myopia: a randomized clinical trial.
Liu, B, Chen, S, Li, Y, Lian, P, Zhao, X, Yu, X, Li, T, Jin, C, Liang, X, Huang, SS, et al
Acta ophthalmologica. 2020;(3):e266-e272
-
-
Free full text
-
Abstract
OBJECTIVE To compare the efficacy and safety of macular buckling and vitrectomy for myopic traction maculopathy showing macular schisis (MS) and associated macular detachment (MD) but without full-thickness macular hole (FTMH). DESIGN Prospective, randomized, parallel, open-label study. METHODS Patients were randomly assigned to either buckling or vitrectomy group. Macular buckling and intravitreal C3F8 gas injection were performed in the buckling group. Small gauge vitrectomy, internal limiting membrane peeling (ILMP) and C3F8 gas tamponade were performed in the vitrectomy group. The patients were followed for 12 months. MAIN OUTCOME MEASURES Best-corrected visual acuity (BCVA) at 12 months. RESULTS A total of 85 patients were randomized, 80 eyes were included (41 receiving buckling, 39 received vitrectomy), and 78 patients completed the study. There were less eyes determined as surgical failure and required a second surgery in the buckling group than vitrectomy the group (2.4% versus 18.4%, p = 0.021). After surgery, macular buckling achieved more improvement in BCVA (+21.7 versus +4.5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, p = 0.002). FTMH development was observed in only 1 (2.4%) eye, after removing of the implant due to recurrent conjunctival erosion, in the buckling group and 10 (26.3%) eyes (seven with-, three without MD) in the vitrectomy group (p < 0.001). More eyes developed cataracts in the vitrectomy group than did in the buckling group (28.9% versus 7.5%, p = 0.014). Macular buckling-associated strabismus (esotropia), binocular diplopia and implant exposure were observed in limited cases. CONCLUSIONS AND RELEVANCE Macular buckling is superior to vitrectomy with ILM peeling plus gas injection for surgical treatment of MS and associated MD in high myopia.
-
4.
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
-
-
Free full text
-
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.
-
5.
The effect of adjunctive intravitreal conbercept at the end of diabetic vitrectomy for the prevention of post-vitrectomy hemorrhage in patients with severe proliferative diabetic retinopathy: a prospective, randomized pilot study.
Jiang, T, Gu, J, Zhang, P, Chen, W, Chang, Q
BMC ophthalmology. 2020;(1):43
Abstract
BACKGROUND To investigate the effect of intravitreal conbercept (IVC) injections on the incidence of postoperative vitreous hemorrhage (VH) in eyes undergoing surgery for severe proliferative diabetic retinopathy. METHODS This was a pilot prospective, comparative, and randomized study. Thirty patients, who underwent vitrectomy for severe proliferative diabetic retinopathy, were assigned randomly to either group 1 (intravitreal conbercept [IVC] injection at the end of pars plana vitrectomy) or group 2 (no IVC injection). Postoperative follow-up was performed on the first day, first week, first month, third month, sixth month and first year after surgery. The primary outcome was the incidence of postoperative VH. Secondary outcomes were the initial time of vitreous clearing (ITVC), best-corrected visual acuity (BCVA) and central retinal thickness (CRT) after surgery. RESULTS A total of 30 eyes, from 30 patients, were included. Fifteen eyes were enrolled in the IVC group and fifteen in the control group. The incidence of early and late postoperative VH was not significantly different between the control and IVC groups. ITVC was shorter in the IVC group than that in the control group, but this was not significant (7.38 ± 10.66 vs 13.23 ± 17.35, P = 0.31). Final BCVA, 1 year after surgery, showed significant improvement compared to baseline in both groups. However, analysis of the BCVA at any postoperative visit after surgery showed no significant differences between the two groups. There were two cases of recurrent VH identified at 3 and 6 months after surgery in each group, requiring a second round of surgery. Foveal thickness was significantly different between the two groups at the 3-month, 6-month and 1-year follow-up visits. CONCLUSIONS In this pilot study, the effect of IVC injection in reducing the incidence of postoperative VH after diabetic vitrectomy at the end of vitrectomy was not shown. TRIAL REGISTRATION The study was registered with the Chinese Clinical Trial Registry. (Reference Number: ChiCTR1800015751).
-
6.
Intravitreal Conbercept Injection as an Adjuvant in Vitrectomy with Silicone Oil Infusion for Severe Proliferative Diabetic Retinopathy.
Gao, S, Lin, Z, Chen, Y, Xu, J, Zhang, Q, Chen, J, Shen, X
Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics. 2020;(5):304-310
Abstract
Purpose: To assess the clinical effects of preoperative, intraoperative, or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in vitrectomy with silicone oil tamponade for severe proliferative diabetic retinopathy (PDR). Methods: Ninety-eight eyes of 98 severe PDR patients undergoing vitrectomy with silicone oil tamponade were randomly assigned to 3 groups: Group 1 (34 eyes) received IVC injections 3 to 5 days before surgery; Group 2 (35 eyes) received IVC injections at the end of surgery; and Group 3 (29 eyes) received IVC injections 3 to 5 days before and at the end of operation. Follow-up examinations were performed for 6 months. Results: The incidence and severity of intraoperative bleeding were not significantly different (P = 0.233). However, the duration of surgery was significantly shorter in Group 1 and Group 3 compared with Group 2 (P < 0.001). The incidences of early and late recurrent vitreous hemorrhage (VH) were 32.35%, 28.57%, and 13.80%, respectively. At 6-month follow-up, mean best-corrected visual acuity had significantly increased to 1.25 ± 0.45 logMAR in Group 1, 1.29 ± 0.46 logMAR in Group 2, 1.16 ± 0.44 logMAR in Group 3 (all P < 0.001). The incidence of postoperative VH, neovascular glaucoma, and retinal detachment in Group 3 was slightly lower, however, no significant differences were observed (all P > 0.05). In young patients, similar results were observed and Group 3 had better visual improvements (P = 0.037). Conclusions: Preoperative IVC injection could be a safe and effective adjunct in pars plana vitrectomy with silicone oil tamponade for severe PDR. Preoperative combined with intraoperative IVC are promising, especially in young patients.
-
7.
The Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT).
Hillier, RJ, Felfeli, T, Berger, AR, Wong, DT, Altomare, F, Dai, D, Giavedoni, LR, Kertes, PJ, Kohly, RP, Muni, RH
Ophthalmology. 2019;(4):531-539
Abstract
PURPOSE The optimal surgery to repair rhegmatogenous retinal detachment (RRD) is unknown. The purpose of this trial was to compare outcomes of pneumatic retinopexy (PnR) versus pars plana vitrectomy (PPV) for the management of primary RRD. DESIGN Prospective, randomized controlled trial. PARTICIPANTS Patients with RRD demonstrating a single retinal break or a group of breaks in detached retina within 1 clock hour above the 8- and 4-o'clock meridians, with any number, location and size of retinal breaks or lattice degeneration in attached retina. METHODS Patients were randomized to undergo either PnR or PPV. Macula-on and macula-off patients were assigned to intervention group by stratified randomization and were treated within 24 and 72 hours, respectively. MAIN OUTCOME MEASURES The primary outcome was 1-year Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA). Important secondary outcomes were subjective visual function (25-item National Eye Institute Visual Function Questionnaire), metamorphopsia score (M-CHARTS), and primary anatomic success. RESULTS One hundred seventy-six patients were recruited between August 2012 and May 2016. ETDRS VA after PnR exceeded that after PPV by 4.9 letters at 12 months (79.9±10.4 letters vs. 75.0±15.2 letters; P = 0.024). Mean ETDRS VA also was superior for the PnR group compared with the PPV group at 3 months (78.4±12.3 letters vs. 68.5±17.8 letters) and 6 months (79.2±11.1 letters vs. 68.6±17.2 letters). Composite 25-item National Eye Institute Visual Function Questionnaire scores were superior for PnR at 3 and 6 months. Vertical metamorphopsia scores were superior for the PnR group compared with the PPV group at 12 months (0.14±0.29 vs. 0.28±0.42; P = 0.026). Primary anatomic success at 12 months was achieved by 80.8% of patients undergoing PnR versus 93.2% undergoing PPV (P = 0.045), with 98.7% and 98.6%, respectively, achieving secondary anatomic success. Sixty-five percent of phakic patients in the PPV arm underwent cataract surgery in the study eye before 12 months versus 16% in the PnR group (P < 0.001). CONCLUSIONS Pneumatic retinopexy should be considered the first line treatment for RRD in patients fulfilling Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT) recruitment criteria. Pneumatic retinopexy offers superior VA, less vertical metamorphopsia, and reduced morbidity when compared with PPV.
-
8.
APOPTOSIS AND ANGIOFIBROSIS IN DIABETIC TRACTIONAL MEMBRANES AFTER VASCULAR ENDOTHELIAL GROWTH FACTOR INHIBITION: Results of a Prospective Trial. Report No. 2.
Jiao, C, Eliott, D, Spee, C, He, S, Wang, K, Mullins, RF, Hinton, DR, Sohn, EH
Retina (Philadelphia, Pa.). 2019;(2):265-273
-
-
Free full text
-
Abstract
PURPOSE We sought to characterize the angiofibrotic and apoptotic effects of vascular endothelial growth factor (VEGF)-inhibition on fibrovascular epiretinal membranes in eyes with traction retinal detachment because of proliferative diabetic retinopathy. METHODS Membranes were excised from 20 eyes of 19 patients (10 randomized to intravitreal bevacizumab, 10 controls) at vitrectomy. Membranes were stained with antibodies targeting connective tissue growth factor (CTGF) or VEGF and colabeled with antibodies directed against endothelial cells (CD31), myofibroblasts, or retinal pigment epithelium markers. Quantitative and colocalization analyses of antibody labeling were obtained through immunofluorescence confocal microscopy. Masson trichrome staining, cell counting of hematoxylin and eosin sections, and terminal dUTP nick-end labeling staining were performed. RESULTS High levels of fibrosis were observed in both groups. Cell apoptosis was higher (P = 0.05) in bevacizumab-treated membranes compared with controls. The bevacizumab group had a nonsignificant reduction in colocalization in CD31-CTGF and cytokeratin-VEGF studies compared with controls. Vascular endothelial growth factor in extracted membranes was positively correlated with vitreous levels of VEGF; CTGF in extracted membranes was negatively correlated with vitreous levels of CTGF. CONCLUSION Bevacizumab suppresses vitreous VEGF levels, but does not significantly alter VEGF or CTGF in diabetic membranes that may be explained by high baseline levels of fibrosis. Bevacizumab may cause apoptosis within fibrovascular membranes.
-
9.
Comparison of a Three-Dimensional Heads-Up Display Surgical Platform with a Standard Operating Microscope for Macular Surgery.
Talcott, KE, Adam, MK, Sioufi, K, Aderman, CM, Ali, FS, Mellen, PL, Garg, SJ, Hsu, J, Ho, AC
Ophthalmology. Retina. 2019;(3):244-251
Abstract
PURPOSE To assess safety, efficacy, and outcomes of vitreoretinal surgery for macular pathology using a 3-dimensional heads-up display (3D HUD) surgical platform compared with a standard operating microscope (SOM). DESIGN Prospective, single-center, unmasked, randomized study. PARTICIPANTS Patients undergoing pars plana vitrectomy (PPV) for epiretinal membrane (ERM) or full-thickness macular hole (MH) at Wills Eye Hospital. METHODS Patients were randomized 1:1 to undergo surgery with a 3D HUD surgical platform or SOM. Patients who had previous PPV were excluded. Surgical choices, including PPV gauge, were based on surgeon preference. Standard surgical safety parameters, Early Treatment Diabetic Retinopathy Study visual acuity (VA), minimum required endoillumination levels, operative times, and surgeon "ease of use" of the viewing platform were recorded. Patients were followed up to postoperative month 3 (POM3). MAIN OUTCOME MEASURES The main outcome measures were total operative time, macular peel time, surgeon rating of viewing system ease of use, minimum required endoillumination, intraoperative complication rate, and postoperative VA. RESULTS Thirty-nine eyes of 39 patients with a mean age of 67.60±8.21 SD years were enrolled. Indications included ERM (n = 26 [3D HUD = 14, SOM = 12]) and MH (n = 13 [3D HUD = 9, SOM = 4]). Minimum required endoillumination was significantly lower with 3D HUD (mean 22.70%±15.10% SD) compared with SOM (mean 39.06%±2.72%; P < 0.001). There was no significant difference in overall operative time, but macular peel time was significantly longer using 3D HUD (mean 14.76±4.79 minutes) than SOM (11.87±8.07 minutes; P = 0.004). Surgeon-reported ease of use was significantly higher (easier) using SOM compared with 3D HUD (P = 0.004). There was no statistically significant difference between the groups in POM3 logarithm of the minimum angle of resolution (logMAR) VA or change in logMAR VA from baseline (all P > 0.681). There were no clinically significant intraoperative complications in either group. CONCLUSIONS Three-dimensional heads-up display surgical visualization is an evolving technology demonstrating comparable efficacy to the SOM for macular surgery. Although overall surgical times were similar, 3D HUD macular peel times were longer and associated with less ease of use in this study, which may partly be due to a learning curve with new technology.
-
10.
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.