Three-year real-world outcomes of intravitreal anti-VEGF therapies in patients affected by myopic choroidal neovascularization

Purpose: To describe real world data in patients affected by myopic choroidal neovascularization (CNV) treated with anti-vascular endothelial growth factors (VEGFs) and to compare our results with previous studies and clinical trials. Methods: This retrospective monocentric cohort study analyzed 96 eyes of 96 myopic-CNV patients treated with an anti-VEGF pro-re-nata regimen over a 3-year-long follow up period. Aflibercept and Ranibizumab were considered as first-line agents whereas Bevacizumab was reserved on a compassionate basis in patients outside the criteria for treatment. All patients underwent a best-corrected visual acuity (BCVA) recording at each follow up visit. Results: Our data showed that all three molecules produced significant improvements in BCVA at year 1, with no significant differences between the three drugs. Moreover, during the second year of treatment, Ranibizumab and Bevacizumab showed a significant improvement in the visual function. However, at year 3 of treatment, the data available indicated the BCVA improvement was not significant with Ranibizumab and Bevacizumab. In addition, no significant difference in the average number of injections between the three groups was detected over the follow up period. No serious adverse events were recorded, but five minor adverse events documented. Conclusion: Our study correlates with previous studies showing significant BCVA gains with the use of these molecules. Similarly, all three molecules seem to provide a similar duration of effects as previous studies have shown, with a low ocular adverse event rate.

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Long-term treatment of endometriosis with dienogest: Real-world results from the VIPOS study

Journal of Endometriosis and Pelvic Pain Disorders ◽

10.1177/2284026521993688 ◽

2021 ◽

pp. 228402652199368

Author(s):

Sabine Moehner ◽

Kerstin Becker ◽

Jens A Lange ◽

Sophia von Stockum ◽

Marco Serrani ◽

...

Keyword(s):

Adverse Events ◽

Real World ◽

Health Care Professionals ◽

Study Entry ◽

Safety Signal ◽

Real World Data ◽

Serious Adverse Events ◽

Long Term Treatment

Introduction: The Visanne Post-approval Observational Study (VIPOS) was designed to assess the safety of dienogest 2 mg (DNG, Visanne) compared to other hormonal endometriosis treatments. Methods: Large, prospective, non-interventional, active surveillance study in six European countries (Germany, Poland, Russia, Hungary, Switzerland, and Ukraine). Women with a new hormonal therapy for endometriosis were enrolled by gynecologists and specialized centers between 2010 and 2016 and observed for up to 7 years. Self-administered questionnaires during study entry and follow-up collected information on baseline characteristics, health status and endometriosis treatment. Self-reported clinical outcomes of interest were validated by health care professionals. Results: Among the >27,000 enrolled participants, 3262 women started DNG use either at study entry or during follow-up. A total of 798 study participants used DNG during follow-up continuously for 15 months or longer (DNG long-term users). When comparing the occurrence of serious adverse events (SAE) in users treated with DNG, no safety signal emerged for long-term users; the SAE incidence rate per 10,000 women-years was 367.7 (95% CI: 274.1–481.9) in DNG long-term users and 416.4 (349.1–492.5) in short-term users (treated with DNG for less than 15 months). Conclusions: Previous data on DNG long-term safety were derived from studies with relatively low numbers of patients and limited follow-up time. VIPOS provided valuable real-world data on the long-term use of DNG 2 mg in around 800 women treated in Europe and observed no safety signal regarding serious adverse events.

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Efficacy of treatment with Ombitasvir, Paritaprevir / r + Dasabuvir over 8 versus 12 weeks in chronic HCV hepatitis genotype 1B

Romanian Journal of Infectious Diseases ◽

10.37897/rjid.2021.1.6 ◽

2021 ◽

Vol 24 (1) ◽

pp. 44-50

Author(s):

Mircea Manuc ◽

◽

Carmen Monica Preda ◽

Laura Iliescu ◽

Doina Istratescu ◽

...

Keyword(s):

Adverse Events ◽

Real World ◽

Drop Out ◽

Real World Data ◽

Serious Adverse Events ◽

Intention To Treat ◽

Genotype 1B ◽

Male Patients ◽

Severe Adverse Events ◽

Chronic Hcv

Background and aims. For the 8-week OPrD regimen, real world data are insufficient. This study aims to compare the efficacy of the two types of regimens (12-week versus 8-week) in a real world cohort of patients with genotype 1b. Material and methods. We analysed a multicentric retrospective cohort enrolling 1436 patients who started HCV therapy in 2018-2019. Liver fibrosis was staged in all subjects by Fibromax. Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post-treatment (SVR12). Results. Out of the 1436 analysed patients, 112 received 8 weeks therapy and 1324 received 12 weeks. In this cohort the proportion of male patients was 25.2%, the median age 61 years, 28.2% were interferon pre-treated, and the rate of co-morbidities was 47%. 42% of the subjects had F2 fibrosis, 29% F1 fibrosis, 16% F3 and 12% F4. The SVR rate was comparable in both groups of patients (97% in those treated with OPrD 12 weeks vs 96.4% in those that received OPrD 8 weeks) (by intention-to-treat). In the 12 weeks arm, the drop-out rate was 0.8% and the rate of severe adverse events was 1%, while in the arm of 8 weeks therapy there were no severe adverse events reported and no drop-out (p = 0.25). The only predictive factor for non-response in both treatment arms was the male sex. Conclusions. OPrD 8 weeks proved to be highly efficient in our patients with a 96.4% SVR. No serious adverse events and no drop out were reported.

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Real world experience with coronary sinus reducer implantation for the treatment of refractory angina: a single-centre experience

European Heart Journal ◽

10.1093/eurheartj/ehab724.1203 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

J P Dias Ferreira Reis ◽

R Ramos ◽

P Rio ◽

A Fiarresga ◽

D Cacela ◽

...

Keyword(s):

Coronary Sinus ◽

Real World ◽

Therapeutic Option ◽

Objective Evaluation ◽

Short Version ◽

Refractory Angina ◽

Single Centre ◽

Real World Data ◽

Serious Adverse Events

Abstract Background Coronary sinus Reducer device (CSF) implantation is a novel therapeutic option to relieve symptoms in patients with refractory angina (RA). There is limited real-world data describing its use outside of clinical trials. Aim To assess the safety and efficacy of this procedure in a real-world setting. Methods This is a report of a single centre prospective registry of consecutive patients with RA (CCS II-IV) deemed unsuitable for revascularization. Between May 2017 and August 2019, 17 patients were referred to CSF implantation. Baseline and follow-up evaluation consisted of clinical assessment, including completion of the short version of the Seattle Angina Questionnaire (SAQ-7) and CCS class evaluation and objective evaluation by transthoracic echocardiography and cardiopulmonary exercise test (CPET). Results A total of 13 patients (70,6±6,5 years, 76,9% male) underwent CSF implantation with a procedural success of 84.6%. No cases of periprocedural serious adverse events were reported. At 12-month follow-up, any reduction in CCS Class was achieved in 72.7% of cases, with 27.2% reducing 2 CCS classes. Baseline CCS score was reduced from 2.8±0.4 to 1.7±0.8 (p=0.009). Quality of life (QoL) was significantly improved as assessed by the improvement seen in all items of SAQ-7 (p<0.017 for all). CPET duration was significantly increased (p=0.034), but no change was noted in the remainder CPET variables. During follow-up, 3 patients suffered myocardial infarction, resulting in 1 death. Conclusion CSF implantation in patients with RA was safe and led to a significant reduction of the angina burden and improvement of QoL at 12-month follow-up. FUNDunding Acknowledgement Type of funding sources: None.

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Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study

Cancers ◽

10.3390/cancers13215550 ◽

2021 ◽

Vol 13 (21) ◽

pp. 5550

Author(s):

Morten Fink ◽

Anders Schwartz Vittrup ◽

Lars Bastholt ◽

Inge Marie Svane ◽

Marco Donia ◽

...

Keyword(s):

Adverse Events ◽

Metastatic Melanoma ◽

Real World ◽

Negative Impact ◽

Cox Proportional Hazards Model ◽

Induction Phase ◽

Discontinue Treatment ◽

Real World Data ◽

World Data ◽

Significant Difference

Immune-related adverse events (irAEs) are very prevalent when treating patients with ipilimumab and nivolumab in combination, and 30–40% of patients discontinue the treatment for this reason. It is of high clinical relevance to investigate the consequences of discontinuing the treatment early since combination therapy with ipilimumab and nivolumab is the first line of treatment for many patients with metastatic melanoma. In this follow-up study, with real-world data from the nationwide DAMMED database, we investigated whether there was a difference in progression-free survival (PFS) and overall survival (OS) for patients who discontinued or did not discontinue treatment within the first four doses of treatment due to irAEs. In total, 448 patients were treated with ipilimumab and nivolumab. Of these, 133 patients discontinued due to irAEs in the induction phase. Using the Cox proportional hazards model, there was no significant difference in PFS when comparing the group that discontinued with the group that did not discontinue. The group that discontinued had a significantly longer OS than the group that received the full length of treatment. Therefore, we conclude that there is no significant negative impact on efficacy for patients who discontinue due to irAEs in the induction phase of combination immunotherapy for metastatic melanoma.

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Efficacy and Safety of Eltrombopag with or without Immunosuppressant in Patients with Relapsed/Refractory Acquired Aplastic Anemia: A Real-World Experience

Blood ◽

10.1182/blood-2021-145549 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 1124-1124

Author(s):

Jiang Ji ◽

Ziqi Wan ◽

Jing Ruan ◽

Yali Du ◽

Miao Chen ◽

...

Keyword(s):

Adverse Events ◽

Aplastic Anemia ◽

Median Time ◽

Relapse Rate ◽

Real World ◽

Reticulocyte Count ◽

Efficacy And Safety ◽

Overall Response ◽

Significant Difference

Abstract Background: Eltrombopag (EPAG) with or without immunosuppressant (IST) has been applied in acquired aplastic anemia (AA), yet data of EPAG+IST in relapsed/refractory AA was limited, and no study has compared efficacy and safety between EPAG+IST and EPAG monotherapy in relapsed/refractory AA patients. Aims: To evaluate and compare the efficacy and safety between EPAG+IST and EPAG monotherapy in relapsed/refractory AA patients in a real-world setting. Methods: Data from patients diagnosed as acquired AA in our center were retrospectively collected. All the enrolled patients were refractory/relapsed to the standard IST for at least 6 months before EPAG. All patients had been treated with EPAG, which was started at 25 mg/day and increased every 2 weeks to a maximum of 150 mg/day until a best response was achieved. Meanwhile, some patients were treated with cyclosporin A (CsA) or tacrolimus (FK506) at the same time. EPAG had to be prescribed for at least 6 months before evaluation. Complete response (CR), overall response (OR) and relapse rate, as well as adverse events and factors which could affect efficacy were analyzed. Results: Totally 99 patients (83 non-severe AA (NSAA) and 16 SAA) were included in the study. The median age at EPAG initiation was 46 (13-88) years old, the median time of EPAG treatment was 11 (6-41) months and the median time of follow-up was 18 (6-41) months. 72 patients were treated with EPAG+IST, including 41 (56.9%) treated with EPAG+FK506 and 31 (43.1%) treated with EPAG+CsA. 27 patients were treated with EPAG alone. No significant difference was found between EPAG+IST group and EPAG group in patient baseline characteristics like age, male proportion, NSAA proportion, presence of PNH clone, proportion of previous ATG+CsA / CsA treatment, previous IST duration and dosage. With compatible follow-up time, EPAG exposure duration and dosage, there was no significant difference in OR/CR rate at 3 rd/6 th/12 th month between patients who was treated with EPAG+FK506 and EPAG+CsA. Under similar compatible baseline conditions, the OR rate was 33.3% vs 22.2% (P=0.284) at 3 rd month, 61.1% vs 37.0% (P=0.032) at 6 th month, and 67.2% vs 42.1% (P=0.051) at 12 th month for patients treated with EPAG+IST and EPAG alone, respectively, but no significant difference was found in time to response (3 (1-12) vs 3 (1-7) months, P=0.679) or CR rate at 3 rd/6 th/12 th month (6.9%/12.5%/20.7% vs 3.7%/7.4%/5.3%, P>0.05) between the two groups. Relapse occurred at 6 th to 12 th month of EPAG treatment, and the relapse rate at 12 th month was 9.8% and 27.3% (P=0.154) for patients treated with EPAG+IST and EPAG alone, respectively. For patients treated with EPAG+IST, responders had a significantly higher baseline reticulocyte count (60.25 (11.5-230.5)×10 9/L vs 16.7 (6.6-56.6)×10 9/L, P=0.040) compared with non-responders. No predictive factors for the overall response were found for patients treated with EPAG alone. Adverse events which led to dosage regulation were gastrointestinal disorders (2.8% vs 3.7%, P=1.000), elevated creatinine (2.8% vs 0, P=0.599), elevated ALT (1.4% vs 0, P=1.000) and arthralgia (0 vs 3.7%, P=0.280) for patients with EPAG+IST and EPAG, respectively. No deaths were found in either group, while the clone evolution rate was 2.8% and 3.7% (P=1.000) in EPAG+IST and EPAG monotherapy group, respectively. Conclusion: EPAG+IST had higher OR rate than EPAG monotherapy with similar side effects for patients with relapsed/refractory acquired AA. Those with higher baseline reticulocyte count were more likely to respond to EPAG+IST. Key words: relapsed/refractory, aplastic anemia, eltrombopag, immunosuppressant, efficacy Disclosures No relevant conflicts of interest to declare. OffLabel Disclosure: In the presented study, eltrombopag was prescribed in relapsed/refractory aplastic anemia patients.

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P305 Effectiveness and Safety of Vedolizumab in Biologic-Naïve Patients: Real-World Data from the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD)

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.429 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S333-S333

Author(s):

F Macaluso ◽

W Fries ◽

S Renna ◽

A Viola ◽

M Muscianisi ◽

...

Keyword(s):

Clinical Response ◽

Real World ◽

Primary Outcome ◽

Real World Data ◽

Mayo Score ◽

Significant Difference ◽

Bowel Diseases ◽

Observational Cohort ◽

Inflammatory Bowel

Abstract Background Biologic-naïve patients treated with Vedolizumab (VDZ) are largely underrepresented in real-world cohorts. We performed a multicentre, observational, cohort study on the effectiveness and safety of VDZ as treatment for Crohn’s disease (CD) and ulcerative colitis (UC) among biologic-naïve subjects. Methods Data of consecutive biologic-naïve patients with CD and UC treated with VDZ from July 2016 to December 2019 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). The primary outcome was the clinical response at 14 and 52 weeks evaluated with Harvey Bradshaw Index in CD and partial Mayo score in UC. Results 172 consecutive patients (CD: n=88; UC: n=84; median age 66.0 years) were included, with a median follow-up of 58.8 weeks. After 14 weeks, a clinical response was reported in 68.2% of patients with CD and 67.9% of patients with UC treated with VDZ, including 45.5% patients in the CD group and 46.4% patients in the UC group who achieved steroid-free remission. After 52 weeks, a clinical response was reported in 77.4% of CD and in 73.8% of UC patients treated with VDZ, including 59.7% patients in the CD group and 60.7% patients in the UC group who achieved steroid-free remission. All differences between CD and UC were not statistically significant. Cox survival analysis showed no significant difference in the probability of treatment discontinuation between CD and UC patients (log-rank p=0.73). Conclusion This large, real-world, multicenter study demonstrated the effectiveness and safety of VDZ as a first-line biologic, showing high rates of clinical response and steroid-free remission at both induction and maintenance.

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Intravitreal aflibercept for management of choroidal neovascularization secondary to angioid streaks

European Journal of Ophthalmology ◽

10.1177/1120672120928305 ◽

2020 ◽

pp. 112067212092830

Author(s):

Maurizio Battaglia Parodi ◽

Maria Vittoria Cicinelli ◽

Alessandro Marchese ◽

Chiara Giuffrè ◽

Francesco Viola ◽

...

Keyword(s):

Visual Acuity ◽

Adverse Events ◽

Choroidal Neovascularization ◽

Central Macular Thickness ◽

Angioid Streaks ◽

Serious Adverse Events ◽

Corrected Visual Acuity ◽

Intravitreal Aflibercept ◽

Best Corrected Visual Acuity

Purpose To investigate the effect and the safety of intravitreal aflibercept in patients affected by choroidal neovascularization secondary to angioid streaks with a long-term follow-up. Methods Multicentre, open-label, phase IIb study (EYLEA-STRIE, EudraCT Number 2014-000986-30) involving four Italian centres (IRCCS Ospedale San Raffaele (Milano), Fondazione G.B. Bietti (Roma), Policlinico (Milano), Ospedale Luigi Sacco (Milano)). Patients with active choroidal neovascularization secondary to angioid streaks with foveal involvement were prospectively enrolled and followed for 18 months. All the patients received intravitreal 2 mg/0.05 mL aflibercept at the time of enrolment, followed by a pro-re-nata regimen for 48 weeks. Best-corrected visual acuity and central macular thickness were measured monthly. Adverse events were monitored at each visit. Results Twenty-three eyes of 20 patients were analysed. Mean number of injections per patient was 4.30 ± 1.2. At week 48, the best-corrected visual acuity was 0.42 ± 0.40 LogMAR (p = 0.6 from baseline) and 18 eyes (81.8%) featured stability within 15 letters. The central macular thickness significantly reduced (p = 0.03). Eleven ocular non-serious adverse events and two serious adverse events were observed (one case of endophthalmitis and one case of acute gastritis were reported). Conclusion Intravitreal aflibercept represents a valid option for the management of choroidal neovascularization complicating angioid streaks. Further studies with longer follow-up and different therapeutic regimens are warranted to ascertain the best control of the disease.

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PERsistent Sitagliptin treatment & Outcomes (PERS&O 2.0) study, long-term results: a real-world observation on DPP4-inhibitor effectiveness

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2020-001507 ◽

2020 ◽

Vol 8 (1) ◽

pp. e001507

Author(s):

Antonio Carlo Bossi ◽

Valentina De Mori ◽

Carlotta Galeone ◽

Davide Pietro Bertola ◽

Margherita Gaiti ◽

...

Keyword(s):

Adverse Events ◽

Real World ◽

Repeated Measures ◽

Long Term Results ◽

Italian Population ◽

Drug Survival ◽

Kaplan Meier ◽

Significant Difference

IntroductionSitagliptin is a dipeptidyl peptidase 4 inhibitor for the treatment of type 2 diabetes (T2D). Limited real-world data on its effectiveness and safety are available from an Italian population.Research design and methodsWe evaluated long-term clinical data from the single-arm PERsistent Sitagliptin Treatment & Outcomes (PERS&O) study, which collected information on 440 patients with TD2 (275 men, 165 women; mean age 64.1 years; disease median duration: 12 years) treated with sitagliptin ‘add-on’. For each patient, we estimated the 10-year cardiovascular (CV) risk using the UK Prospective Diabetes Study (UKPDS) Risk Engine (RE). Drug survival was evaluated using Kaplan-Meier survival curves; repeated measures mixed effects models were used to evaluate the evolution of glycated hemoglobin (HbA1c) and CV risk during sitagliptin treatment.ResultsAt baseline, most patients were overweight or obese (median body mass index (BMI) (kg/m2) 30.2); median HbA1c was 8.4%; median fasting plasma glucose: 172 mg/dL; median UKPDS RE score: 24.8%, being higher in men (median 30.2%) than in women (median 17.0%) as expected. Median follow-up from starting sitagliptin treatment was 5.6 years. From Kaplan-Meier curves, the estimated median drug survival was 32.8 months when considering discontinuation for any cause and 58.4 months when considering discontinuation for loss of efficacy. A significant improvement in HbA1c was evident during treatment with sitagliptin (p<0.01): the reduction was rapid (median HbA1c after 4–6 months: 7.5%) and continued at longer follow-up. When comparing patients treated with sitagliptin versus those stopping sitagliptin and switching to another antihyperglycemic drug, we detected a significant difference in the evolution of HbA1c in favor of patients who continued sitagliptin treatment. The UKPDS RE score at 10 years and the BMI significantly improved during treatment with sitagliptin (p<0.001). Adverse events were relatively uncommon.ConclusionPatients with T2D treated with sitagliptin achieved an improvement in metabolic control and a reduction in CV risk and did not experience relevant adverse events.

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Update on Alefacept Safety

Journal of Cutaneous Medicine and Surgery ◽

10.2310/7750.2009.00032 ◽

2009 ◽

Vol 13 (6_suppl) ◽

pp. S139-S147 ◽

Cited By ~ 6

Author(s):

Denise Wexler ◽

Gordon Searles ◽

Ian Landells ◽

Neil H. Shear ◽

Robert Bissonnette ◽

...

Keyword(s):

Adverse Events ◽

Real World ◽

Plaque Psoriasis ◽

Safety Data ◽

Study Drug ◽

Chronic Plaque Psoriasis ◽

Serious Adverse Events ◽

Patient Request ◽

Real World Evidence

Background: Alefacept has been demonstrated in clinical trials to be an effective, safe, and well-tolerated treatment strategy when used alone or in combination with other antipsoriatic therapies in patients with chronic plaque psoriasis. Objective: AWARE (Amevive Wisdom Acquired from Real-World Evidence) is a multicenter, observational, Canadian phase IV registry evaluating the efficacy and safety of alefacept, alone or in combination with other antipsoriatic therapies, in patients with psoriasis. Methods: Patients with chronic plaque psoriasis were treated with at least one course of alefacept followed by an off-treatment period, typically lasting 12 or more weeks. Prospective follow-up was at least 60 weeks, depending on when patients presented for retreatment. Safety data collected throughout the study included the incidence of serious adverse events (SAEs), dosing suspensions, and withdrawals owing to adverse events. Results: Twelve SAEs were reported in psoriasis patients treated with at least one course of alefacept, with only one considered to be possibly related to the study drug. Approximately one-quarter of patients missed at least one dose of alefacept during the course of the study. A total of 291 doses of alefacept were missed, representing almost 4% of the total doses administered in this group of patients. Low CD4+ count was the most frequent reason for missed doses; however, no patient had persistently low CD4+ counts requiring permanent discontinuation of alefacept treatment. Seven patients in the AWARE registry discontinued treatment with alefacept, with the most common reason being patient request. Conclusion: The AWARE study supports the safety of alefacept used alone or in combination with other antipsoriatic therapies, in a broad population of real-world chronic plaque psoriasis patients in Canada.

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Modified Posterior Scleral Reinforcement as a Treatment for High Myopia in Children and Its Therapeutic Effect

BioMed Research International ◽

10.1155/2019/5185780 ◽

2019 ◽

Vol 2019 ◽

pp. 1-7

Author(s):

Zequn Miao ◽

Luojia Li ◽

Xiaoli Meng ◽

Lili Guo ◽

Di Cao ◽

...

Keyword(s):

Adverse Events ◽

Therapeutic Effect ◽

Refractive Error ◽

Axial Length ◽

High Myopia ◽

Serious Adverse Events ◽

Significant Difference ◽

Posterior Scleral Reinforcement ◽

Age Range

Purpose. To investigate the safety and therapeutic effect of a modified posterior scleral reinforcement (PSR) in treating high myopia. Methods. A total of 85 highly myopic eyes in 47 children (6.3±3.6 years of age, range from 3 years to 15 years) who underwent this modified PSR were included in this study. Axial length, refractive error, best-corrected visual acuity (BCVA), macular scans, and adverse events were recorded before the operation (as a baseline) and in postoperative reviews taken yearly for 5 years. Results. This was a 5-year research: 50% of the children (20 children, 40 eyes) participated in the 6-month review, 41% of the children (17 children, 33 eyes) participated in the 1-year review, 26% of the children (11 children, 21 eyes) participated in the 2-year review, 16% of the children (7 children, 13 eyes) participated in the 3-year review, 13% of the children (5.3 children, 11 eyes) participated in the 4-year review, and 8% of the children (3.3 children, 7 eyes) participated in the 5-year review. Compared with the baseline, axial elongation was significantly changed (P<0.05) over the 5-year period in all of the children: 6-month (P=0.003), 1-year (P=0), 2-year (P=0), 3-year (P=0), 4-year (P=0), and 5-year (P=0). The axial length was extended. No significant difference was found in refractive error between measurements taken at baseline and at the 5-year postoperative visit in all of the children: 6-month (P=0.51), 1-year (P=0.50), 2-year (P=0.46), 3-year (P=0.56), 4-year (P=0.30), and 5-year (P=0.16). There were significant differences in BCVA between measurements taken at baseline and at the postoperative 5-year visit in all the children: 6-month (P=0), 1-year (P=0), 2-year (P=0), 3-year (P=0), 4-year (P=0), and 5-year (P=0). BCVA improved in 71 eyes (83.52%), remained stable in 14 eyes (16.47%), and declined in none of the children. No serious adverse events occurred before the operation and during the 5-year follow-up period. Conclusion. This modified PSR could be a therapeutic treatment for high myopia.

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