scholarly journals A Randomized Controlled Trial of Conbercept Pretreatment before Vitrectomy in Proliferative Diabetic Retinopathy

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Xiaochun Yang ◽  
Jianbiao Xu ◽  
Ruili Wang ◽  
Yan Mei ◽  
Huo Lei ◽  
...  

Purpose.To determine the efficacy and safety of preoperative intravitreal conbercept (IVC) injection before vitrectomy for proliferative diabetic retinopathy (PDR).Methods.107 eyes of 88 patients that underwent pars plana vitrectomy (PPV) for active PDR were enrolled. All patients were assigned randomly to either preoperative IVC group or control group. Follow-up examinations were performed for three months after surgery. The primary bioactivity measures were severity of intraoperative bleeding, incidence of early and late recurrent VH, vitreous clear-up time, and best-corrected visual acuity (BCVA) levels. The secondary safety measures included intraocular pressure, endophthalmitis, rubeosis, tractional retinal detachment, and systemic adverse events.Results.The incidence and severity of intraoperative bleeding were significantly lower in IVC group than in the control group. The average vitreous clear-up time of early recurrent VH was significantly shorter in IVC group compared with that in control group. There was no significant difference in vitreous clear-up time of late recurrent VH between the two groups. Patients that received pretreatment of conbercept had much better BCVA at 3 days, 1 week, and 1 month after surgery than control group. Moreover, both patients with improved BCVA were greater in IVC group than in control group at each follow-up.Conclusions.Conbercept pretreatment could be an effective adjunct to vitrectomy in accelerating postoperative vitreous clear-up and acquiring stable visual acuity restoration for PDR.


2013 ◽  
Vol 5 ◽  
pp. OED.S12352 ◽  
Author(s):  
Mehmet Demir ◽  
Ersin Oba ◽  
Efe Can ◽  
Orhan Kara ◽  
Sonmez Cinar

We evaluated the effect of intravitreal bevacizumab (IVB) injection before pars plana vitrectomy (PPV) on intravitreal hemorrhage (VH) during and after vitrectomy for postoperative the first day and the first month in pseudophakic patients with proliferative diabetic retinopathy (PDR). This retrospective study was performed on 44 eyes of 44 patients who underwent vitrectomy for PDR. Patients were divided into PPV (n = 22 eyes) and PPV + IVB (n = 22 eyes) groups. Injection of bevacizumab (1.25 mg/0.05 mL) was performed 3 days before vitrectomy. Outcomes of visual acuity as well as intraoperative and postoperative VH were compared between the two groups. One month after surgery, visual acuity improved in PPV and PPV + IVB groups ( P = 0.005, P = 0.006), respectively. There was no difference between the two groups in best corrected visual acuity at baseline and after vitrectomy ( P = 0.71). Intraoperative bleeding into the vitreous was recorded in 14 (63.6%) cases in the PPV group and in 7 (31.8%) cases in the PPV + IVB group. The first month, intravitreal hemorrhage was recorded in six patients in the PPV group and in two patients in the PPV + IVB group ( P = 0.03). The mean pre-postoperative central macular thickness was similar in both groups. Intravitreal injection of IVB before vitrectomy decreased the rate of VH at the time of surgery and at the first postoperative month in patients with PDR.



2018 ◽  
Vol 12 (1) ◽  
pp. 308-313
Author(s):  
Arief S Kartasasmita ◽  
Prettyla Yollamanda ◽  
Grimaldi Ihsan ◽  
Rova Virgana

Objective:To compare the change in central subfield macular thickness following single-session and multiple-session laser panretinal photocoagulation in subjects with diabetic retinopathy.Methods:A single-center, randomized controlled trial study was performed on 28 eyes of 16 patients with severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy. Eyes were randomly assigned for treatment with panretinal photocoagulation performed either in single-session or multiple-session divided into three sessions during two-week period. Central subfield macular thickness was quantified using spectral domain optical coherence tomography and changes at four weeks follow-up were compared to the baseline measurement.Result:Mean baseline central subfield macular thickness of 12 eyes underwent single-session and 16 eyes underwent multiple-session panretinal photocoagulation were 342.91+109.51 micrometers and 354+171.79 micrometers (p> .05), respectively. Mean post laser central subfield macular thickness in the single-session group was 305.83+81.95 micrometers and 389.75+229.51 micrometers in the multiple-session group (p> .05). Mean central subfield macular thickness changes four weeks post laser was 37.08+94.21 micrometers for eyes treated with single-session and -35.75+123.62 micrometers for the multiple-session treated eyes (p= .101).Conclusion:There was no significant difference in change of central subfield macular thickness at four weeks post laser from treatment with single-session and multiple-session panretinal photocoagulation. Single-session panretinal photocoagulation can be used as effective multiple-session panretinal photocoagulation for the treatment of diabetic retinopathy.



Author(s):  
Danilo Moyses Jorge ◽  
José Edísio da Silva Tavares Neto ◽  
Omero Benedicto Poli-Neto ◽  
Ingrid U. Scott ◽  
Rodrigo Jorge

Abstract Background The main purpose of this study is to compare the vitreous hemorrhage (VH) score reduction and visual acuity outcomes in patients with VH secondary to proliferative diabetic retinopathy (PDR) treated with intravitreal injections of bevacizumab (IVB) versus IVB and pars plana vitrectomy (IVB and PPV). Methods Patients with VH secondary to PDR were randomized into 2 groups: in Group A, patients were treated with a total of 3 IVB (1.5 mg/0.06 ml) at 8-week intervals; and in Group B, patients received a single IVB (1.5 mg/0.06 ml) and, 7 days later, underwent PPV. Patients received an ophthalmic evaluation that included best-corrected visual acuity (BCVA), indirect ophthalmoscopy, and mode B echography at weeks 8, 16 and 24. VH was classified according to the Diabetic Retinopathy Vitrectomy Study classification as grade 1, 2 or 3. Change in VH score was the primary outcome measure and change in BCVA was the secondary outcome. Results Seventy-three eyes of 66 patients were randomized and 70 eyes completed the 24-week follow-up visit. Mean VH score reduction (± SEM) of 0.4571 ± 0.0283 (p = 0.0014), 1.3429 ± 0.0393 (p < 0.0001) and 1.8286 ± 0.0438 (p < 0.001) was observed in Group A at 8, 16 and 24 weeks after treatment, respectively (Table 2; Fig. 2). In Group B, the reduction of VH score (± SEM) was 2.2571 ± 0.0720 (p = 0.0014), 2.2857 ± 0.0606 (p < 0.0001) and 2.2286 ± 0.0726 (p < 0.001) at 8, 16 and 24 weeks after treatment, respectively. Group comparison revealed a significantly greater reduction in mean VH score in Group B at 8 and 16 weeks after treatment (p < 0.0001). However, at 24 weeks this difference was no longer statistically significant (p = 0.1854). In Group A, mean (± SEM) BCVA showed an improvement of 0.00285 ± 0.0004 (p = 0.971), 0.5371 ± 0.0072 (p < 0.0001), 0.8143 ± 0.0001 (p < 0.0001) and 0.8543 ± 0.0008 (p < 0.0001) compared to baseline at 1, 8, 16 and 24 weeks after treatment, respectively. In Group B, mean (± SEM) BCVA showed an improvement of 0.3657 ± 0.0507 (p = 0.0002), 0.8857 ± 0.0385 (p < 0.0001), 0.9457 ± 0.0499 (p < 0.0001) and 0.9629 ± 0477 (p < 0.0001) compared to baseline at 1, 8, 16 and 24 weeks after treatment, respectively. No significant difference in BCVA improvement was observed between groups at 24 weeks after treatment. Conclusion PPV with preoperative IVB is associated with more rapid clearance of VH and improvement in BCVA than IVB injections alone. However, after 24 weeks of follow-up, the reduction in VH score and BCVA were similar between both treatment strategies. Trial Registration The project is registered in Plataforma Brasil with CAAE number 927354.7.0000.5440 and was approved by the Ethics Committee of the Clinics Hospital of Ribeirao Preto Medicine School of São Paulo University—Ribeirão Preto, São Paulo, Brazil (appreciation number 3.053.397 gave the approval).



2003 ◽  
Vol 13 (5) ◽  
pp. 468-473 ◽  
Author(s):  
J.B. Jonas ◽  
A. SÖfker ◽  
R. Degenring

Purpose To evaluate the safety and efficacy of intravitreal injections of crystalline triamcinolone acetonide as an adjunctive procedure in pars plana vitrectomy for proliferative diabetic retinopathy. Methods This nonrandomized comparative study included 30 patients (32 eyes) who underwent standardized pars plana vitrectomy for treatment of proliferative diabetic retinopathy and who received an intravitreal injection of 25 mg triamcinolone acetonide at the end of surgery. Mean follow-up time was 5.60 ± 5.14 months. The study group was compared with a control group (32 eyes) matched with the study group for preoperative and intraoperative parameters and who underwent pars plana vitrectomy for proliferative diabetic retinopathy without intravitreal injection of triamcinolone acetonide. Results The study group and the control group did not vary significantly in frequency of postoperative retinal detachment, re-pars plana vitrectomy, or postoperative enucleation or phthisis bulbi, or in best postoperative visual acuity, visual acuity at end of the study, or gain in visual acuity. Conclusions In this pilot study, the study group with pars plana vitrectomy and intravitreal triamcinolone acetonide injection compared with the nonrandomized control group without intravitreal triamcinolone acetonide injection did not show a higher than usual rate of postoperative complications. As a corollary, however, the data do not suggest the adjunct use of 25 mg intravitreal triamcinolone acetonide combined with pars plana vitrectomy as treatment of proliferative diabetic retinopathy.



2018 ◽  
Vol 146 (3-4) ◽  
pp. 131-135
Author(s):  
Nenad Petrovic ◽  
Dusan Todorovic ◽  
Suncica Sreckovic ◽  
Tatjana Sarenac-Vulovic ◽  
Mirjana Janicijevic-Petrovic ◽  
...  

Introduction/Objective. Vitreal hemorrhage (VH) is one of the possible complications of the diabetic retinopathy which is followed by intensive decrease of visual acuity. Corticosteroides are commonly used in treatment of different retinal diseases, due to their antiinflammatory and anti-angiogenetic effect. Triamcinolone acetonide applied invtravitreally remains in the eye for several months, releases its crystals and decreases the density of vitreal hemorrhage. The aim of this study was to evaluate the efficacy of 20 mg intravitreal triamcinolone acetonide for the managementof long lasting VH, occurred as a complication of proliferative diabetic retinopathy (PDR) in non-vitrectomized eyes. Methods. In prospective study, from January 1st 2015 until the January 1st 2016, 24 patients with VH who received intravitreal triamcinolone acetonide, were compared to 21 patients from the control group (patients with PDR and similar degree of VH). All patients passed ophthalmological examination at the beginning of the study, 7 days, 1, 3, 6, 9 and 12 months after intravitreal application of 20mg triamcinolone acetonide. Besides VH and visual acuity, intraocular pressure and cataract development were also analyzed. Results. Statistically significant difference was recorded 1st and 3rd month after the usage of triamacinolone, in the density of vitreal hemorrhage and visual acuity. Twenty-nine percent of patients had temporally intraocular pressure rise after the intravitreal triamacinolone application, and 4.1% of patients ended the study with the developed cataract. Conclusion. Intravitreally applied triamcinolone acetonide has moderate and temporary influence on the velocity of vitreal hemorrhage reabsorption. It can be useful treatment option when the vitrectomy in not possible.



2018 ◽  
Vol 24 (27) ◽  
pp. 3276-3281 ◽  
Author(s):  
Dorota Raczyńska ◽  
Katarzyna A. Lisowska ◽  
Krzysztof Pietruczuk ◽  
Joanna Borucka ◽  
Mateusz Ślizień ◽  
...  

Objective: The objective of the study was to compare cytokine levels in the vitreous body of patients with proliferative diabetic retinopathy (PDR) undergoing posterior vitrectomy. Patients and methods: The study included 39 patients (39 eyes) undergoing pars plana vitrectomy (PPV). Patients were divided into three groups: patients with proliferative diabetic retinopathy (PDR) without aflibercept injection prior to the surgery, PDR patients administered aflibercept injection prior to the surgery, and patients without diabetes mellitus (control group). All patients underwent a comprehensive eye examination one day before and 3 weeks after the surgery, including measurements of: best-corrected visual acuity (BVCA) and intraocular pressure (IOP), slit-lamp examination and spectral domain optical coherence tomography (SOCT). Concentrations of cytokines: IL-6, IL-8, IL-12p70, TNF, IL-10, IL-1β were measured in the vitreous body of patients with BD™ Cytometric Bead Array (CBA) Human Inflammatory Cytokines Kit. Results: PDR patients who received pretreatment with aflibercept injection showed significantly lower concentrations of IL-12p70, TNF, IL-10 and IL-1β in the vitreous body compared to the control group. Meanwhile, patients without prior aflibercept injection had a significantly higher concentration of IL-8. There was also a significant positive correlation between IOP before PPV and IL-8 concentration in both PDR patients’ groups. Conclusion: Findings of our study suggest an important role of IL-8 in the development of severe PDR. Aflibercept administration on the day before elective vitrectomy facilitated the surgery.



2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.



2019 ◽  
Vol 8 (12) ◽  
pp. 2217 ◽  
Author(s):  
Parviz Mammadzada ◽  
Juliette Bayle ◽  
Johann Gudmundsson ◽  
Anders Kvanta ◽  
Helder André

MicroRNAs (miRNAs) can provide insight into the pathophysiological states of ocular tissues such as proliferative diabetic retinopathy (PDR). In this study, differences in miRNA expression in vitreous from PDR patients with and without incidence of recurrent vitreous hemorrhage (RVH) after the initial pars-plana vitrectomy (PPV) were analyzed, with the aim of identifying biomarkers for RVH. Fifty-four consented vitreous samples were analyzed from patients undergoing PPV for PDR, of which eighteen samples underwent a second surgery due to RVH. Ten of the sixty-six expressed miRNAs (miRNAs-19a, -20a, -22, -27a, -29a, -93, -126, -128, -130a, and -150) displayed divergences between the PDR vitreous groups and to the control. A significant increase in the miRNA-19a and -27a expression was determined in PDR patients undergoing PPV as compared to the controls. miRNA-20a and -93 were significantly upregulated in primary PPV vitreous samples of patients afflicted with RVH. Moreover, this observed upregulation was not significant between the non-RVH and control group, thus emphasizing the association with RVH incidence. miRNA-19a and -27a were detected as putative vitreous biomarkers for PDR, and elevated levels of miRNA-20a and -93 in vitreous with RVH suggest their biomarker potential for major PDR complications such as recurrent hemorrhage incidence.



2021 ◽  
Author(s):  
Binita Bhattarai ◽  
Saraswati Khadka, Thapa ◽  
Hari Bahadur Thapa ◽  
Sandip Bashyal ◽  
Bhesh Bikram Thapa, Chhetri ◽  
...  

BACKGROUND Diabetic Retinopathy (DR) is an emerging public health issue. DR may lead to severe visual impairment or blindness. Referral communication and tracking system is helpful to monitor patients flow, timeliness and compliance; ensures a close relationship across health facilities and improves patient’s satisfaction. The aim of the study is to improve timely referral flow and compliance of patients diagnosed with DR. OBJECTIVE Primary objective: To assess the effect of intervention on timely referral compliance Secondary objectives: To assess the determinants and cost effectiveness of the intervention for timely referral compliance. METHODS This is an operational research study using cluster randomized controlled health facility-based trial. A situational analysis was conducted and problem tree was developed to identify different barriers to referral compliance (long waiting time, lack of knowledge about diabetic retinopathy, its impact on vision and different treatment options).Appropriate solutions were identified through comprehensive literature review and addressing individual barriers to improve poor referral and compliance of patients diagnosed with DR from peripheral centres (referring centre). These solutions were systemically arranged in the form of an intervention package, which will be tested using a cluster-based randomized controlled trial. Ten eligible peripheral hospitals out of 19will be randomly selected and allocated (lottery method); five each in intervention and control groups. Structured counselling and referral communication linkage will be implemented to the intervention group. Structured counselling, health educational material, and telephonic follow-up will be provided by a trained counsellor at the referring centre; patients will be told in detail about DR, its impact on eyes and vision, treatment options available and the treatment cost for different procedures. They will be explained process at LEIRC (referral centre) and a contact person shall facilitate their treatment at the referral centre. Patients in Control group will receive ongoing routine counselling and health education material. We collected data on referral and compliance, and their determinants using referral-and DR-registers, and structured questionnaires for 1.demographic and socioeconomic profile of patients, 2.telephonicfollow-up with noncompliant patients,3.Feedback of those referred, and 4.Performa for clinical information. Compliance is considered when the referred participant reports at referral centre within one month of counselling. Referral compliance between the two groups will be compared using appropriate statistical tests. Adjusted analysis will be conducted. RESULTS Due to COVID-19 pandemic the inflow of patients is reduced, thus the duration of the data collection will be increased. In the first 6 months of pilot data collection73 in intervention and 34 in control group were screened for referral; 12(21.82%) and 15(27,2%) already had severe NPDR or PDR at the time of screening. CONCLUSIONS Early stage of DR is asymptomatic and can go unnoticed until it affects vision leading to visual impairment and blindness. This study will assess the feasibility and effectiveness of a referral intervention package for improving early diagnosis and treatment with preservation of vision among DR patients. CLINICALTRIAL Clinicaltrials.gov NCT 04834648



Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Yibo Li ◽  
Lili Zhu ◽  
Raoying Wang ◽  
Xingyue Yang ◽  
Xinqi Jiang ◽  
...  

Abstract Background Currently, the population with myopia climbs steadily, and is developing toward younger age, posing a great concern to the health of adolescents. Myopia in severe cases can cause irreversible consequences such as glaucoma, blindness, and other complications. At present, the solutions for myopia are glasses, medication, and surgery. This study aims to investigate the role of a physiotherapy category based on guided meditation for vision acuity training on adolescent myopia. Methods This is a prospective, randomized, multicenter clinical trial. One thousand one hundred forty primary and secondary school students aged 8–18 years old from 27 schools will be recruited and randomly divided into an experimental and a control group at a ratio of 2:1 in two phases, with a training period of 30 days in each phase and a follow-up period of 3 months. No interventions will be conducted during the follow-up period, nor will other interventions employed. Inclusion criteria will meet the diagnostic criteria for simple myopia and −6.00D ≤ spherical lenses ≤ −0.50D and cylindrical lenses ≤1.50D. The primary observation index will be to compare the statistical differences in distant visual acuity between the two groups; the secondary observation indexes will be ocular symptoms (mainly including eye fatigue, dryness, pain, double vision, neck pain, thought disorders, and lags in response), diopter, and astigmatism. Discussion The purpose of this two-phase trial is to compare the clinical effectiveness of focused vision-guided meditation with Chinese eye exercises that are also non-pharmacological, non-invasive interventions for myopia, and to maximize the benefit to the subjects. The results will indicate whether the training based on focused vision-guided meditation has the ability to improve distant visual acuity, relieve ocular symptoms, and ameliorate diopter. In addition, this trial will provide clinical efficacy of the training, which is expected to provide meaningful data for vision rehabilitation. At the same time, the vision acuity training method, which is permeated with the concept of Traditional Chinese Medicine (TCM) rehabilitation and health maintenance, will be applied to achieve the goal of preventing or alleviating myopic development and reducing myopia rate. Trial registration Chinese Clinical Trial Registry ChiCTR2000038642. Registered on 26 September 2020



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