scholarly journals Guided meditation for vision acuity training on adolescent myopia: study protocol for an open-label, prospective, multicenter, randomized controlled trial

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

2021 ◽  
Author(s):  
Yibo Li ◽  
Lili Zhu ◽  
Raoying Wang ◽  
Xinqi Jiang ◽  
Tao Lu

Abstract Background: Currently, the population with myopia climbs steadily, and 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. 1140 primary and secondary school students aged 8-18 years old from 27 schools will be recruited and randomly divided into an experimental group 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, 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 (identifier: ChiCTR2000038642; Registered 26 September 2020, http://www.chictr.org.cn/showproj.aspx?proj=61729).


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.


2020 ◽  
Author(s):  
YANG BAI ◽  
Ying Wang ◽  
Bo Chen ◽  
Qianqian Lei ◽  
Hailong Zhao ◽  
...  

Abstract Background There are evidences for the efficacy of acupuncture treatment for chronic shoulder pain, however it remains unclear the best acupuncture modes for effective treatment. We compared the effect of myofascial trigger point (MTrp) Stuck-moving Needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The ultimate aim of the study is to select an effective therapy for patients with idiopathic frozen shoulder. Methods Randomized controlled trial will be conducted in the 3 clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital and Qingyang Second People's Hospital in China from February 2020 to January 2021. One-hundred and eight frozen shoulder patient will be recruited and randomized into one of three groups in a 1:1:1 ratio of the Stuck-moving Needle acupuncture group, Common acupuncture control group and physical exercise control group. This trial will include a 1-week baseline period, a 3-weeks of treatment period, and a 12-weeks of follow-up period. During the 3-weeks of treatment period, patients will receive 9 sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and Measurement of range of joint motion (ROM) from baseline period to the 12-week follow-up period. Secondary outcome measures will include, measurement of Pressure Pain Threshold (PPT), Pressure Pain Tolerance (PTT) Oxford Shoulder Score (OSS), 36-item Short Form survey and Patient satisfaction evaluation. Adverse events also will be recorded for safety assessment. Discussion The results of this trial will allow us to compare the difference in efficacy between Stuck-moving Needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals. Trial registration: Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). registered on 22, Dec. 2019


2020 ◽  
Author(s):  
Shangfei Yang ◽  
Hui Jiang ◽  
Kailai Nie ◽  
Liwen Feng ◽  
Wei Fan

Abstract Background: The use of capsular tension ring (CTR) implantation to treat cataract patients with weak zonules is still controversial. The aim of this study was to examine the effects of CTR implantation on capsular stability after phacoemulsification in patients with weak zonules, especially patients who have undergone pars plana vitrectomy (PPV) or those who suffer from severe myopia.Methods: A total of 42 patients who underwent phacoemulsification and received an intraocular lens (IOL) were randomized to undergo CTR implantation or not. The control and CTR groups were compared in terms of uncorrected distant visual acuity (UDVA), best corrected distant visual acuity (BCDVA), refractive prediction error, the area of anterior capsulorhexis, and IOL inclination angle. Follow-up visits were conducted postoperatively at 1 day, 1 week, 1 month and 3 months. subgroup analyses were performed based on PPV and severe myopia. Results: Surgery significantly improved UDVA and BCDVA to similar extents in CTR and control patients, and refraction prediction error was similar between the two groups at all follow-up times. At 3 months after surgery, the area of anterior capsulorhexis was significantly larger in CTR patients than in controls (p = 0.0199). These differences were also significant between the subgroups of patients with severe myopia. Vertical IOL inclination was less within CTR groups at 3 months after surgery, especially in patients with severe myopia (p = 0.0286). At 1 week postoperatively, the proportion of individuals whose posterior lens capsule that had completely adhered to the posterior IOL surface was significantly higher among CTR patients (p = 0.023). No serious surgical complications were observed.Conclusion: CTR implantation can benefit cataract patients with weak zonules by maintaining the shape of the capsular bag, reducing capsule shrinkage and stabilizing IOL inclination.Trial registration: Chinese Clinical Trial Registry ChiCTR-INR-17011217, date of registration April 22, 2017, prospectively registered.


Author(s):  
Kai-ni Shen ◽  
Wei-jun Fu ◽  
Yu Wu ◽  
Yu-jun Dong ◽  
Zhong-xia Huang ◽  
...  

Background: Doxycycline was demonstrated in a retrospective study to be associated with greater survival in patients with light chain (AL) amyloidosis. Therefore, we prospectively compared the efficacy of bortezomib-cyclophosphamide-dexamethasone (CyBorD) and CyBorD combined with doxycycline for cardiac AL amyloidosis. Methods: This was a multicenter, open-label randomized controlled trial. Patients with Mayo 2004 stage II-III AL amyloidosis were included. Patients were randomized to doxycycline 100 mg twice daily along with 9 cycles of CyBorD (doxycycline group) or to 9 cycles of CyBorD alone (control group). The primary outcome was 2-year progression-free survival (PFS). PFS was defined as the time from randomization to death, hematologic progression or organ progression (heart, kidney or liver). Hematologic progression was defined based on substantial increase in free light chain. Increase in either N-terminal pro B-type natriuretic peptide or cardiac troponin was the main criterion for defining cardiac progression. Cardiac PFS, defined as the time from randomization to cardiac progression or death, was compared between groups in an exploratory analysis. The corresponding treatment hazard ratio was estimated using a Cox regression model. Results: 140 patients underwent randomization, with 70 in each group. The median age was 61 (range, 33-78) years with a male: female ratio of 1.75:1. Stage II disease was present in 34 (48.6%) and 33 (47.1%) patients in the doxycycline and control groups, respectively. After a median follow-up duration of 24.4 months, 32/70 (45.7%) of patients in the doxycycline group and 30/70 (42.9%) of patients in the control group experienced progression. PFS was not significantly different between groups (hazard ratio 0.97, 95% CI, 0.59-1.60, p =0.91). Cardiac progression occurred in 29/70 (41.4%) of patients in the doxycycline group and 26/70 (37.1%) of patients in the control group. The death rates for both groups by the end of follow-up was the same, 25/70 (35.7%). There were no significant differences observed for either cardiac PFS (hazard ratio 0.91, 95% CI, 0.54-1.55, p =0.74) or overall survival (hazard ratio 1.04, 95% CI, 0.60-1.81, p =0.89). Conclusions: Our trial demonstrated that doxycycline combined with CyBorD failed to prolong PFS or cardiac PFS compared with CyBorD alone in cardiac AL amyloidosis. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03401372.


2017 ◽  
Vol 2017 ◽  
pp. 1-16 ◽  
Author(s):  
Alessandro Cucchi ◽  
Elisabetta Vignudelli ◽  
Simonetta Franco ◽  
Luca Levrini ◽  
Dario Castellani ◽  
...  

Purpose. To evaluate the survival, success, and complication rates of tapered double-lead threads single implants, placed in fresh extraction sockets and healed sites of the posterior jaws. Methods. The enrolled patients were randomly divided into 2 groups: in the test group (TG), all implants were inserted at the time of tooth extraction; in the control group (CG), all implants were placed 3 months after extraction. The implants were followed for a period of 1 to 3 years after loading. The main outcomes were implant survival, complications, and implant-crown success. Results. Ninety-two patients had 97 installed implants (49 in the TG, 48 in the CG). Only two implants failed, in the TG; the survival rates were therefore 95.9% (47/49) and 100% (48/48) for TG and CG, respectively. In the surviving implants, no complications were reported, for an implant-crown success of 100%. Conclusions. Although a significant difference was found in the levels of primary stability between TG and CG, single implants placed in fresh extraction sockets and healed sites of the posterior jaws had similar survival and complication rates. Crestal bone levels and peri-implant bone resorption showed similar values. A longer follow-up period is however required, to confirm these positive outcomes.


2013 ◽  
Vol 2013 ◽  
pp. 1-4 ◽  
Author(s):  
Yuan-shi Liu ◽  
Li-gong Xue ◽  
Xiao-jian Ma ◽  
Chun-shan Liu

To evaluate the effectiveness of long-round needle therapy for pain relief in patients with knee osteoarthritis, 192 patients were included in a multicenter, randomized, controlled trial. 97 patients were randomized to the long-round needle therapy group (EG), and 95 patients were randomized to the control group (CG). In EG, the long-round needle therapy was performed once every 7 days for 3 therapy sessions. Ibuprofen sustained-release capsules were administered orally in CG, 1 pill each time, twice daily for 3 weeks. Curative effect was measured after the therapy and was evaluated at a 3-month follow-up interview. In EG, the treatment resulted in a basic cure for 79 patients, was effective for 15 patients, and was ineffective for 1 patient. In CG, the treatment resulted in a basic cure for 30 patients, was effective for 38 patients, and was ineffective for 21 patients. In the follow-up examination in EG, 75 patients were basically cured, and the treatment was effective for 11 patients and ineffective for 9. In CG, 22 were basically cured, 31 found the treatment effective, and 36 found the treatment ineffective. The curative effects in EG after both the treatment and the 3-mouth followup were significantly more superior than that in CG (P<0.01) which should be adopted more widely.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Shangfei Yang ◽  
Hui Jiang ◽  
Kailai Nie ◽  
Liwen Feng ◽  
Wei Fan

Abstract Background The use of capsular tension ring (CTR) implantation to treat cataract patients with weak zonules is still controversial. The aim of this study was to examine the effects of CTR implantation on capsular stability after phacoemulsification in patients with weak zonules, especially patients who have undergone pars plana vitrectomy (PPV) or those who suffer from severe myopia. Methods A total of 42 patients who underwent phacoemulsification and received an intraocular lens (IOL) were randomized to undergo CTR implantation or not. The control and CTR groups were compared in terms of uncorrected distant visual acuity (UDVA), best corrected distant visual acuity (BCDVA), refractive prediction error, the area of anterior capsulorhexis, and IOL inclination angle. Follow-up visits were conducted postoperatively at 1 day, 1 week, 1 month and 3 months. Subgroup analyses were performed based on PPV and severe myopia. Results Surgery significantly improved UDVA and BCDVA to similar extents in CTR and control patients, and refraction prediction error was similar between the two groups at all follow-up times. At 3 months after surgery, the area of anterior capsulorhexis was significantly larger in CTR patients than in controls (p = 0.0199). These differences were also significant between the subgroups of patients with severe myopia. Vertical IOL inclination was less within CTR groups at 3 months after surgery, especially in patients with severe myopia (p = 0.0286). At 1 week postoperatively, the proportion of individuals whose posterior lens capsule that had completely adhered to the posterior IOL surface was significantly higher among CTR patients (p = 0.023). No serious surgical complications were observed. Conclusion CTR implantation can benefit cataract patients with weak zonules by maintaining the shape of the capsular bag, reducing capsule shrinkage and stabilizing IOL inclination. Trial registration Chinese Clinical Trial Registry ChiCTR-INR-17011217, date of registration April 22, 2017, prospectively registered.


2021 ◽  
Author(s):  
Du Yun ◽  
Yatong Li ◽  
Xianyun Fu ◽  
Yanan Luo ◽  
Chenjie Li

Abstract BackgroundPrimary dysmenorrhea (PD) is one of main gynecological complaints in women of child-bearing age, but there are limited effective treatments available. Guizhi Fuling Wan (GFW), one of the most widely known traditional Chinese medicine (TCM) herbal formulas, has been the treatment of choice for gynecological disease in China. A growing number of studies have shown that GFW is beneficial for patients with PD. However, the quality of evidence is limited, and there are few studies on the treatment of PD by GFW with specific TCM syndromes. Therefor we will conduct a randomized controlled trial to explore the efficacy and safety of GFW for PD patients with heat-burning blood-stasis syndrome.Methods and analysisThis study is designed as a randomized, double-blinded, placebo-controlled clinical trial. Eligible patients will be randomly assigned to the GFW group (patients receive GFW) and the control group (patients receive a matching placebo) in a 1:1 ratio. The participants will receive either GFW or placebo, twice daily for 3 menstrual cycles with a 3-month follow-up. The primary outcome is the pain intensity reduction measured by a Visual Analog Scale. The secondary outcomes is the Cox Menstrual Symptom Scale, the Self-rating Depression Scale, the Self-rating Anxiety Scale, the 12-item Short-Form Health Survey and the dysmenorrhea diarymenstrual pain.. All outcomes are assessed at baseline, and the 4th, 8th, and 12th week during the interventions, as well as at the 16th, 20th and 24th week follow-up. Any adverse events will be recorded throughout the study.DiscussionThis is the first double-blinded RCT to assess the effectiveness and safety of GFW in treating PD with the heat-burning blood-stasis syndrome. The scientific and rigorous methodology design of this trial will provide significant evidence regarding the use of GFW to treat PD in future.Trial registrationChinese Clinical Trial Registry, ID: ChiCTR2000034118. Regisrered on 25 June 2020.


2020 ◽  
Author(s):  
YANG BAI ◽  
Ying Wang ◽  
Bo Chen ◽  
Yinan QIN ◽  
Qianqian Lei ◽  
...  

Abstract Background: There are evidence for the efficacy of acupuncture treatment for chronic shoulder pain, however, it remains unclear the best acupuncture modes for effective treatment. We compared the effect of the myofascial trigger point (MTrp) Stuck-moving Needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The aim of present study is to select an effective therapy for patients with idiopathic frozen shoulder.Methods: Randomized controlled trial will be conducted in the three clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital and Qingyang Second People's Hospital in China from February 2020 to January 2021. One-hundred and eight frozen shoulder patients will be recruited and randomized into one of three groups in a 1:1:1 ratio of the Stuck-moving Needle acupuncture group, Common acupuncture control group and physical exercise control group. This trial will include a 1-week baseline period, a 3-weeks of the treatment period, and a 12-weeks of the follow-up period. During the 3-weeks of the treatment period, patients will receive nine sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and measurement of range of joint motion (ROM) from the baseline period to the 12-week follow-up period. Secondary outcome measures will include, measurement of Pressure Pain Threshold (PPT), Pressure Pain Tolerance (PTT) Oxford Shoulder Score (OSS), 36-item Short Form survey and Patient satisfaction evaluation. Adverse events also will be recorded for safety assessment.Discussion: The results of this trial will allow us to compare the difference in efficacy between Stuck-moving Needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals.Trial registration: Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). registered on 22, Dec. 2019


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