Efficacy and Safety of Rhomboid Intercostal Block for Analgesia in Breast Surgery and Thoracoscopic Surgery: A Meta-Analysis

Abstract BackgroundRhomboid intercostal block (RIB) is a new regional anesthesia technique that provides postoperative analgesia for breast surgery and thoracoscopic surgery. The published papers are not yet fully integrated and do not adequately address the impact and safety of the RIB on postoperative pain.MethodsThe PubMed, Web of Science and Embase were searched from 2016 to 2021 for all available randomized controlled trials (RCTs) that evaluated the analgesic efficacy and safety of RIB after thoracic surgery and breast surgery. Random and fixed-effects meta-analytical models were used where indicated, and between-study heterogeneity was assessed. The primary outcome was Postoperative Numerical Rating Scale (NRS) scores of patients at rest recorded 0-1, 6-8, 24 hours after surgery. The secondary outcomes included rate of postoperative nausea and vomiting (PONV), postoperative fentanyl consumption and presence of complications of the block. ResultsFrom 81 records identified, four studies met our inclusion criteria, including 216 patients (RIB:108 patients; no block: 108 patients). In the primary outcome, RIB group showed significantly lower postoperative NRS at rest at first 0-1 h and 6-8 h (weighted mean difference [WMD] = -1.55; 95% confidence internal [CI] = -2.92 to -0.19; p<0.05), (WMD = -0. 69; 95% CI = -1.29 to -0. 09; p<0. 05). And there was no significant difference between groups in NRS at rest at 24 h (WMD = -0.78; 95% CI = -1.64 to -0.08; p=0.77). Also, RIB group showed significantly lower postoperative NRS of breast surgery and thoracoscopic surgery at 0-1h (WMD = -3.00; 95% CI = -3.13 to -2.87; p<0.01), (WMD = -1.08; 95% CI = -1.98 to -0.18; p<0.05). In the secondary outcome, the analysis also showed RIB group had significant lower of POVN rates (summary relative risk (RR) = 0.212;95%CI = 0.10 to 0.45; p<0. 01) and the postoperative consumption of fentanyl (WMD= -57.52;95%CI = -106.03 to -9.02; p<0. 05). ConclusionThis review shows that RIB was more effective in controlling acute pain after breast surgery and thoracoscopic surgery than general analgesia. And RIB is also a kind of effective and safe bock technology.

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Quantum Movement Technique versus William Flexion Exercise on Pain and Walking Ability in Patients with Low Back Pain

Open Access Macedonian Journal of Medical Sciences ◽

10.3889/oamjms.2020.4457 ◽

2020 ◽

Vol 8 (A) ◽

pp. 323-325

Author(s):

Djohan Aras ◽

Nur Asmi ◽

Yudi Hardianto ◽

Rabia Rabia ◽

Anwar Mallongi

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Primary Outcome ◽

Rating Scale ◽

Secondary Outcome ◽

Walking Ability ◽

Low Back ◽

Significant Difference ◽

Numeric Pain Rating Scale ◽

Pain Rating Scale

OBJECTIVE: Our study aimed to compare between quantum movement technique (QMT) and William flexion exercise (WFE) in patients with low back pain (LBP) based on pain and walking ability. METHODS: Six-session QMT and WFE were provided for two groups of participants. The frequency of intervention was 6 times/week. Twenty patients (aged 25–65 years) with LBP were randomly assigned into the QMT group (n = 10) or the WFE group (n = 10). The primary outcome of the intervention was pain, measured using the numeric pain rating scale, while the secondary outcome was walking ability, measured using the Oswestry Disability Index. The measurements were conducted at baseline and the end of the intervention. RESULTS: Pain reduction was significantly shown in both groups (p < 0.05). However, QMT was shown more effective in reducing pain compared to WFE (p < 0.05). In addition, we found the significant improvement of walking ability in both groups following the intervention (p < 0.05), but no significant difference was shown between two groups (p > 0.05). CONCLUSIONS: QMT is more effective than WFE for reducing pain in patients with LBP.

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Abstract 12983: Impact of Door to Balloon Time on Outcome of Patients Presenting With Different Symptom Onset to Door Time

Circulation ◽

10.1161/circ.130.suppl_2.12983 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Razvan T Dadu ◽

Ana Davis ◽

Jaromir Bobek ◽

Mahboob Alam ◽

Rajiv Goswami ◽

...

Keyword(s):

Symptom Onset ◽

Primary Outcome ◽

Tertiary Care ◽

Composite Endpoint ◽

Coronary Intervention ◽

Late Presentation ◽

Secondary Outcome ◽

Significant Difference ◽

St Elevation ◽

The Impact

Objective: Delay in reperfusion > 4h in patients with ST elevation myocardial infarction (STEMI) is associated with negative outcomes. We sought out to examine the impact of DTBT on 30-day cardiovascular outcomes and persistent ST elevation (STE) on the post reperfusion EKG, in patients with different symptom onset to door time (SOTDT). Methods: 122 consecutive patients undergoing primary percutaneous coronary intervention for STEMI in a tertiary care county hospital from 2011-2013 are included. All patients had DTBT ≤ 90min. Patients were divided into 3 groups according to their SOTDT: Group1 ≤ 90min, Group2 between 90min and 4h and Group3 >4h. Each group was further divided in 2 subgroups based on median DTBT of the entire population. The primary outcome was a composite endpoint of mortality, re-hospitalization for chest pain or heart failure, repeat revascularization and re-infarction at 30 days. A secondary outcome was persistence of > 50% STE on the post reperfusion EKG. Results: Median SOTDT was 129 min and the median DTBT was 47min for all included patients in the study. The 3 groups had comparable baseline characteristics. The mean DTBT was similar (49±20 min, 47±18 min and 50±16 min, p=0.7). In the 3 groups, the primary outcome was present in 16.7 %, 16.2 % and 35%, respectively (p=0.08) and there was a significant difference in STE resolution: 16.7%, 17.1% and 78.6%, respectively (p<0.001). Group 1 and 3 demonstrate that short DTBT (≤ 47 min) does not affect overall outcomes compared to those with longer DTBT (> 47 min). In group 2, patients with DTBT ≤ 47min had significantly lower persistent STE on EKG (0% vs 36.8%, p=0.002) and a trend to a favorable clinical outcome (table). Conclusion: Patients with intermediate SOTDT seem to benefit mostly from shorter DTBT compared to all other patient groups. Achieving shorter DTBT may have no impact on outcome in patients with very early or very late presentation. Larger studies are needed to further confirm these findings.

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Donepezil for mild cognitive impairment in Parkinson’s disease

Scientific Reports ◽

10.1038/s41598-021-84243-4 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Kyoungwon Baik ◽

Seon Myeong Kim ◽

Jin Ho Jung ◽

Yang Hyun Lee ◽

Seok Jong Chung ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Cognitive Impairment ◽

Mild Cognitive Impairment ◽

Treatment Group ◽

Outcome Measures ◽

Rating Scale ◽

Secondary Outcome ◽

Control Group ◽

Significant Difference

AbstractWe investigated the efficacy of donepezil for mild cognitive impairment in Parkinson’s disease (PD-MCI). This was a prospective, non-randomized, open-label, two-arm study. Eighty PD-MCI patients were assigned to either a treatment or control group. The treatment group received donepezil for 48 weeks. The primary outcome measures were the Korean version of Mini-Mental State Exam and Montreal Cognitive Assessment scores. Secondary outcome measures were the Clinical Dementia Rating, Unified Parkinson’s Disease Rating Scale part III, Clinical Global Impression scores. Progression of dementia was assessed at 48-week. Comprehensive neuropsychological tests and electroencephalography (EEG) were performed at baseline and after 48 weeks. The spectral power ratio of the theta to beta2 band (TB2R) in the electroencephalogram was analyzed. There was no significant difference in the primary and secondary outcome measures between the two groups. However, the treatment group showed a significant decrease in TB2R at bilateral frontotemporoparietal channels compared to the control group. Although we could not demonstrate improvements in the cognitive functions, donepezil treatment had a modulatory effect on the EEG in PD-MCI patients. EEG might be a sensitive biomarker for detecting changes in PD-MCI after donepezil treatment.

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The Impact of Time Interval between Hepatic Resection and Liver Transplantation on Clinical Outcome in Patients with Hepatocellular Carcinoma

Cancers ◽

10.3390/cancers13102398 ◽

2021 ◽

Vol 13 (10) ◽

pp. 2398

Author(s):

Matteo Serenari ◽

Enrico Prosperi ◽

Marc-Antoine Allard ◽

Michele Paterno ◽

Nicolas Golse ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Liver Transplantation ◽

Hepatic Resection ◽

Primary Outcome ◽

Polynomial Regression ◽

Secondary Outcome ◽

Time Interval ◽

Comprehensive Complication Index ◽

Fractional Polynomial ◽

The Impact

Hepatic resection (HR) for hepatocellular carcinoma (HCC) may require secondary liver transplantation (SLT). However, a previous HR is supposed to worsen post-SLT outcomes. Data of patients treated by SLT between 2000 and 2018 at two tertiary referral centers were analyzed. The primary outcome of the study was to analyze the impact of HR on post-LT complications. A Comprehensive Complication Index ≥ 29.6 was chosen as cutoff. The secondary outcome was HCC-related death by means of competing-risk regression analysis. In the study period, 140 patients were included. Patients were transplanted in a median of 23 months after HR (IQR 14–41). Among all the features analyzed regarding the prior HR, only time interval between HR and SLT (time HR-SLT) was an independent predictor of severe complications after LT (OR = 0.98, p < 0.001). According to fractional polynomial regression, the probability of severe complications increased up to 15 months after HR (43%), then slowly decreased over time (OR = 0.88, p < 0.001). There was no significant association between HCC-related death and time HR-SLT at the multivariable competing risks regression model (SHR, 1.06; 95% CI: 0.69–1.62, p = 0.796). This study showed that time HR-SLT was key in predicting complications after LT, without affecting HCC-related death.

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Rhomboid intercostal block combined with sub-serratus plane block versus rhomboid intercostal block for postoperative analgesia after video-assisted thoracoscopic surgery: a prospective randomized-controlled trial

BMC Pulmonary Medicine ◽

10.1186/s12890-021-01432-7 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Wei Deng ◽

Xiao-min Hou ◽

Xu-yan Zhou ◽

Qing-he Zhou

Keyword(s):

Rating Scale ◽

Numerical Rating Scale ◽

Thoracoscopic Surgery ◽

Controlled Trial ◽

Ultrasound Guided ◽

Video Assisted ◽

Prospective Randomized Controlled Trial ◽

Numerical Rating ◽

Intercostal Block ◽

Video Assisted Thoracoscopic Surgery

Abstract Background Rhomboid intercostal block (RIB) and Rhomboid intercostal block with sub-serratus plane block (RISS) are the two types of plane blocks used for postoperative analgesia after video-assisted thoracoscopic surgery (VATS). This prospective randomized controlled trial was performed to analyze the postoperative analgesic effects of ultrasound-guided RIB block and RISS block after video-assisted thoracoscopic surgery. Methods Ninety patients aged between 18 and 80 years, with American Society of Anesthesiologists physical status Classes I–II and scheduled for elective unilateral VATS were randomly allocated into three groups. In group C, no block intervention was performed. Patients in group RIB received ultrasound-guided RIB with 20-mL 0.375% ropivacaine and those in group RISS received ultrasound-guided RIB and serratus plane block using a total of 40-mL 0.375% ropivacaine. All patients received intravenous sufentanil patient-controlled analgesia upon arrival in the recovery room. Postoperative sufentanil consumption and pain scores were compared among the groups. Results The dosages of sufentanil consumption at 24 h after the surgery in the RIB and RISS groups were significantly lower than that in group C (p < 0.001 and p < 0.001 for all comparisons, respectively), the postoperative Numerical Rating Scale (NRS) scores in the RIB and RISS groups at 0.5, 1, 3, 6, 12, 18, and 24 h after surgery when patients were at rest or active were significantly lower than that in group C (p < 0.05 for all comparisons). The required dosage of sufentanil and time to first postoperative analgesic request in groupRISS were less than those in the group RIB at 24 h after the surgery (p < 0.001 and p < 0.001 for all comparisons, respectively). Similarly, the Numerical Rating Scale scores for group RISS at 12, 18, and 24 h after the surgery when the patients were active were significantly lower than those for group RIB (p < 0.05 for all comparisons). Conclusion Both ultrasound-guided RIB block and RISS block can effectively reduce the demand for sufentanil within 24 h after VATS, and less sufentanil dosage is needed in patient with RISS block. Ultrasound-guided RIB block and RISS block can effectively relieve pain within 24 h after VATS, and RISS block is more effective.

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Randomized comparison between dexmedetomidine–remifentanil and midazolam–fentanyl for deep sedation during catheter ablation of atrial fibrillation

International Journal of Arrhythmia ◽

10.1186/s42444-019-0002-3 ◽

2019 ◽

Vol 20 (1) ◽

Author(s):

Young Choi ◽

Sung-Hwan Kim ◽

Ju Youn Kim ◽

Youmi Hwang ◽

Tae-Seok Kim ◽

...

Keyword(s):

Atrial Fibrillation ◽

Catheter Ablation ◽

Primary Outcome ◽

Secondary Outcome ◽

Positive Pressure ◽

Efficacy And Safety ◽

Af Ablation ◽

Hemodynamic Compromise ◽

3D Mapping System ◽

Sedative Agents

Abstract Background and objectives The efficacy of dexmedetomidine for radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF) has not been well established. We evaluated the efficacy and safety of sedation using dexmedetomidine with remifentanil compared to conventional sedative agents during RFCA for AF. Subjects and methods A total of 240 patients undergoing RFCA for AF were randomized to either the dexmedetomidine (DEX) group (continuous infusion of dexmedetomidine and remifentanil) or the midazolam (MID) group (intermittent injections of midazolam and fentanyl) according to sedative agents. Non-invasive positive pressure ventilation was applied to all patients during the procedure. The primary outcome was patient movement during the procedure resulting in a 3D mapping system discordance, and the secondary outcome was adverse events including respiratory or hemodynamic compromise. Results During AF ablation, the incidence of the primary outcome was significantly reduced for the DEX group (18.2% vs. 39.5% in the DEX and the MID groups, respectively, p < 0.001). The frequency of a desaturation event (oxygen saturation < 90%) did not significantly differ between the two groups (6.6% vs. 1.7%, p = 0.056). However, the incidences of hypotension not owing to cardiac tamponade (systolic blood pressure < 80 mmHg, 19.8% vs. 8.4%, p = 0.011) and bradycardia (HR < 50 beats/min: 39.7% vs. 21.8%, p = 0.003) were higher in the DEX group. All efficacy and safety results were consistent within the predefined subgroups. Conclusion The combined use of dexmedetomidine and remifentanil provides higher stability sedation during AF ablation, but can lead to more frequent hemodynamic compromise compared to midazolam and fentanyl.

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Efficacy and safety of trimethoprim-sulfamethoxazole for the prevention of pneumocystis pneumonia in human immunodeficiency virus-negative immunodeficient patients: A systematic review and meta-analysis

PLoS ONE ◽

10.1371/journal.pone.0248524 ◽

2021 ◽

Vol 16 (3) ◽

pp. e0248524

Author(s):

Rui Li ◽

Zhiyong Tang ◽

Fu Liu ◽

Ming Yang

Keyword(s):

Human Immunodeficiency Virus ◽

Fixed Effects ◽

Meta Analysis ◽

Pneumocystis Pneumonia ◽

Control Group ◽

Drug Discontinuation ◽

Efficacy And Safety ◽

Significant Difference ◽

Immunodeficiency Virus ◽

Hiv Negative

Background Pneumocystis pneumonia (PCP) has a significant impact on the mortality of immunocompromised patients. It is not known whether the prophylactic application of trimethoprim-sulfamethoxazole (TMP-SMZ) can reduce the incidence of PCP and mortality in the human immunodeficiency virus (HIV)-negative immunodeficient population. The safety profile is also unknown. There have been few reports on this topic. The aim of this study was to systematically evaluate the efficacy and safety of the use of TMP-SMZ for the prevention of PCP in this population of patients from the perspective of evidence-based medicine. Methods A comprehensive search without restrictions on publication status or other parameters was conducted. Clinical randomized controlled trials (RCTs) or case-control trials (CCSs) of TMP-SMZ used for the prevention of PCP in HIV-negative immunocompromised populations were considered eligible. A meta-analysis was performed using the Mantel-Haenszel fixed-effects model or Mantel-Haenszel random-effects model, and odds ratios (ORs) with 95% confidence intervals (CIs) were calculated and reported. Results Of the 2392 records identified, 19 studies (n = 4135 patients) were included. The efficacy analysis results indicated that the PCP incidence was lower in the TMP-SMZ group than in the control group (OR = 0.27, 95% CI (0.10, 0.77), p = 0.01); however, the rate of drug discontinuation was higher in the TMP-SMZ group than in the control group (OR = 14.31, 95% CI (4.78, 42.91), p<0.00001). In addition, there was no statistically significant difference in the rate of mortality between the two groups (OR = 0.54, 95% CI (0.21, 1.37), p = 0.19). The safety analysis results showed that the rate of adverse events (AEs) was higher in the TMP-SMZ group than in the control group (OR = 1.92, 95% CI (1.06, 3.47), p = 0.03). Conclusions TMP-SMZ has a better effect than other drugs or the placebo with regard to preventing PCP in HIV-negative immunocompromised individuals, but it may not necessarily reduce the rate of mortality, the rate of drug discontinuation or AEs. Due to the limitations of the research methodologies used, additional large-scale clinical trials and well-designed research studies are needed to identify more effective therapies for the prevention of PCP.

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Impact of cytochrome P450 2C19 polymorphisms on the clinical efficacy and safety of voriconazole: an update systematic review and meta-analysis

10.22541/au.162546769.92188192/v1 ◽

2021 ◽

Author(s):

Ying Zhang ◽

Xu Hao ◽

Kelu Hou ◽

Lei Hu ◽

Jingyuan Shang ◽

...

Keyword(s):

Cytochrome P450 ◽

Adverse Events ◽

Success Rate ◽

Clinical Efficacy ◽

Search Algorithm ◽

Efficacy And Safety ◽

Increased Risk ◽

Significant Difference ◽

The Impact ◽

Cyp2c19 Polymorphisms

Aims: To assess the impact of cytochrome P450 (CYP) 2C19 polymorphisms on the clinical efficacy and safety of voriconazole. Methods: We systematically searched PubMed, EMBASE, CENTRAL, ClinicalTrials.gov, and three Chinese databases from their inception to March 18, 2021 using a predefined search algorithm to identify relevant studies. Studies that reported voriconazole-treated patients and information on CYP2C19 polymorphisms were included. The efficacy outcome was success rate. The safety outcomes included overall adverse events, hepatotoxicity and neurotoxicity. Results: A total of 20 studies were included. Intermediate metabolizers (IMs) and Poor metabolizers (PMs) were associated with increased success rates compared with normal metabolizers (NMs) (risk ratio (RR): 1.18, 95% confidence interval (CI): 1.03~1.34, I2=0%, p=0.02; RR: 1.28, 95%CI: 1.06~1.54, I2=0%, p=0.01). PMs were at increased risk of overall adverse events in comparison with NMs and IMs (RR: 2.18, 95%CI: 1.35~3.53, I2=0%, p=0.001; RR: 1.80, 95% CI: 1.23~2.64, I2=0%, p=0.003). PMs demonstrated a trend towards an increased incidence of hepatotoxicity when compared with NMs (RR: 1.60, 95%CI: 0.94~2.74, I2=27%, p=0.08), although there was no statistically significant difference. In addition, there was no significant association between CYP2C19 polymorphisms and neurotoxicity. Conclusions: IMs and PMs were at a significant higher success rate in comparison with NMs. PMs were significantly associated with an increased incidence of all adverse events compared with NMs and IMs. Researches are expected to further confirm these findings. Additionally, the relationship between hepatotoxicity and CYP2C19 polymorphisms deservers clinical attention.

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1033. Effectiveness of a Physician-Driven Automated Antibiotic Time Out in the Setting of Gram-negative Bacteremia

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.897 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S363-S364

Author(s):

Sana Mohayya ◽

Navaneeth Narayanan ◽

Daniel Cimilluca ◽

Parth Vaidya ◽

Alexander Malanowski ◽

...

Keyword(s):

Broad Spectrum ◽

Primary Outcome ◽

Secondary Outcome ◽

Antibiotic Prescribing ◽

Gram Negative ◽

Time Out ◽

Days Of Therapy ◽

Gram Negative Bacteremia ◽

Secondary Outcomes ◽

The Impact

Abstract Background In an effort to minimize complications associated with over-utilization of antibiotics, many antimicrobial stewardship programs have incorporated an antibiotic time out (ATO). Despite the increasing adoption of the ATO, limited data are available to support its effectiveness. This study was designed to assess the impact of an automated ATO integrated into the electronic medical record (EMR) on the rate of antibiotic modification in patients receiving broad-spectrum antibiotic(s) for Gram-negative bacteremia (GNB). Methods This was a single-center retrospective cohort study of inpatients from January 2017 to June 2018 conducted at a large academic medical center. ATO was implemented on October 31, 2017. Adult patients with GNB who received at least 72 hours of a systemic antibiotic were included. Patients with neutropenia or polymicrobial infections were excluded. The primary outcome was the proportion of patients who received a modification of therapy within 24 hours of final culture results. Secondary outcomes included modification at any point in therapy, time to modification of therapy, time to de-escalation, and days of therapy of broad-spectrum antibiotics. Results There was a total of 88 patients who met inclusion criteria, 37 patients pre-ATO and 51 patients post-ATO. The primary outcome of modification of therapy within 24 hours of final culture results was not significantly different for patients in the pre-ATO and post-ATO groups (19% vs. 20%, P = 0.94, respectively). The secondary outcome of modification of therapy at any point in therapy was not significantly different between the two groups (62% vs. 66%, P = 0.67). Of the 47 patients who received a modification of therapy, the mean time to modification was significantly shorter in the post-ATO group (52.8 hours vs. 45.26 hours, P < 0.05,). All other secondary outcomes were not significantly different between study groups. Conclusion The ATO alert was not associated with a higher rate of antibiotic modification within 24 hours of culture results in patients with GNB, although there was a significant reduction in the time to antibiotic modification. Further efforts are needed to improve the time to modification and optimize antibiotic prescribing practices. Disclosures All authors: No reported disclosures.

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Effect of medically lowering intraocular pressure in glaucoma suspects with high myopia (GSHM study): study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-020-04748-7 ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 1

Author(s):

Feng Bin Lin ◽

◽

Shi Da Chen ◽

Yun He Song ◽

Wei Wang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Intraocular Pressure ◽

High Myopia ◽

Primary Outcome ◽

Controlled Trial ◽

Secondary Outcome ◽

Rank Test ◽

Inner Plexiform Layer ◽

Randomized Controlled ◽

The Impact

Abstract Background Currently, whether and when intraocular pressure (IOP)-lowering medication should be used in glaucoma suspects with high myopia (GSHM) remains unknown. Glaucoma suspects are visual field (VF) defects that cannot be explained by myopic macular changes or other retinal and neurologic conditions. Glaucoma progression is defined by VF deterioration. Here we describe the rationale, design, and methodology of a randomized controlled trial (RCT) designed to evaluate the effects of medically lowering IOP in GSHM (GSHM study). Methods The GSHM study is an open-label, single-center, RCT for GSHM. Overall, 264 newly diagnosed participants, aged 35 to 65 years, will be recruited at the Zhongshan Ophthalmic Center, Sun Yat-sen University, between 2020 and 2021. Participants will be randomly divided into two arms at a 1:1 ratio. Participants in the intervention arm will receive IOP-lowering medication, while participants in the control arm will be followed up without treatment for 36 months or until they reach the end point. Only one eye per participant will be eligible for the study. If both eyes are eligible, the eye with the worse VF will be recruited. The primary outcome is the incidence of glaucoma suspect progression by VF testing over 36 months. The secondary outcomes include the incidence of changes in the optic nerve head morphology including the retinal nerve fiber layer, and retinal ganglion cell-inner plexiform layer loss, progression of myopic maculopathy, visual function loss, and change in the quality of life. Statistical analyses will include baseline characteristics comparison between the intervention and control groups using a two-sample t-test and Wilcoxon rank sum test; generalized linear models with Poisson regression for the primary outcome; Kaplan-Meier curve and log-rank test for the incidence of the secondary outcome; and longitudinal analyses to assess trends in outcomes across time. Discussion To the best of our knowledge, the GSHM study is the first RCT to investigate the impact of medically lowering IOP in GSHM. The results will have implications for the clinical management of GSHM. Trial registration ClinicalTrials.gov NCT04296916. Registered on 4 March 2020

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