Atropine or Patching for Treatment of Moderate Amblyopia in Children

2020 ◽  
pp. 291-296
Author(s):  
Alan D. Penman ◽  
Kimberly W. Crowder ◽  
William M. Watkins
Keyword(s):  
Clinical Trial ◽  
Visual Acuity ◽  
Randomized Clinical Trial ◽  
Initial Treatment ◽  
Mean Difference ◽  
Treatment Groups ◽  
The Difference

The Patching Versus Atropine Trial was a randomized clinical trial in children less than seven years of age with moderate amblyopia and a visual acuity in the amblyopic eye between 20/40 and 20/100, to determine whether treatment with atropine drops was as effective as patching. The study found that patching and atropine were equally effective in the initial treatment of moderate amblyopia. Visual acuity in the amblyopic eye improved in both groups (improvement from baseline to 6 months was 3.16 lines in the patching group and 2.84 lines in the atropine group). Improvement was initially faster in the patching group, but, after 6 months, the difference in visual acuity between treatment groups was small and clinically inconsequential (mean difference at 6 months, 0.034 logMAR units).

scholarly journals A randomized clinical trial of chlorambucil versus COP in stage B chronic lymphocytic leukemia. The French Cooperative Group on Chronic Lymphocytic Leukemia

Blood ◽  
1990 ◽  
Vol 75 (7) ◽  
pp. 1422-1425 ◽  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Chronic Lymphocytic Leukemia ◽  
Randomized Clinical Trial ◽  
Survival Rates ◽  
Lymphocytic Leukemia ◽  
Cooperative Group ◽  
Survival Times ◽  
Treatment Groups ◽  
Significant Difference

Abstract In 1980, the French Cooperative Group on Chronic Lymphocytic Leukemia started a randomized clinical trial in which intermediate prognosis patients (stage B) received either an indefinite course of chlorambucil (0.1 mg/kg/d) or 12 cycles of the COP regimen (vincristine, cyclophosphamide, and prednisone). We present the results of the third interim analysis based on 291 patients (151 in the chlorambucil group and 140 in the COP group) with a mean follow-up of 53 months at the reference date of June 1, 1987. At this date, 129 deaths were observed, 65 in the chlorambucil group and 64 in the COP group; there was no improvement in overall survival with the COP regimen (P = .44) even after adjusting for both prognostic and imbalanced factors (P = .24). The 3-year and 5-year overall survival rates were, respectively, 69% and 44% in the chlorambucil group as compared with 73% and 43% in the COP group. The median survival times were 58 months in the chlorambucil group and 57 months in the COP group. Moreover, no significant difference was observed between the two treatment groups in terms of either treatment response, 9-month status, time to disease progression to stage C, or causes of death.

Clinical outcomes with the Prestige II cervical disc: preliminary results from a prospective randomized clinical trial

2004 ◽  
Vol 17 (3) ◽  
pp. 1-43 ◽  
Author(s):  
Francois Porchet ◽  
Newton H. Metcalf
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Outcome Measures ◽  
Cervical Disc ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Prospective Randomized Clinical Trial ◽  
Treatment Groups ◽  
Preliminary Results ◽  
The Prestige

Object A prospective, randomized clinical trial was conducted to compare the Prestige II Cervical Disc with anterior decompression and fusion for the treatment of single-level degenerative disease. Standardized clinical outcome measures and radiographic examinations were used at prescribed postoperative intervals to compare the treatment groups. Methods Patients with symptomatic single-level cervical disc disease who met the inclusion/exclusion criteria defined in the protocol were randomized to receive the Prestige II disc or iliac crest autograft fusion. All patients underwent a standardized neurological and radiographic examination and completed outcomes questionnaires (Neck Disability Index and Short Form–36) preoperatively and at each postoperative interval (6 weeks and 3, 6, 12, and 24 months). Two independent radiologists reviewed all x-ray films and assessed motion at the treated level and adjacent segments. Standard statistical methods were used to compare all outcome measures. Preliminary results in 55 patients enrolled in the study are presented. Several patients have reached the final (24-month) follow-up interval. Clinical and radiographic results are encouraging, with significant improvement seen in both treatment groups. Radiographic results show that the Prestige II disc maintains motion at the treated level without adjacent-segment compromise. Conclusions Cervical spine arthroplasty is an exciting and rapidly developing surgical treatment option. An objective comparison with fusion is important to advance this option. This is the first prospective randomized trial in which cervical arthroplasty is compared with fusion. The preliminary results from this limited number of patients indicate that the Prestige II disc is potentially a viable alternative to fusion for primary cervical disc disease; however, further clinical studies with larger sample sizes will be required to show statistical equivalence.

scholarly journals The Comparison of the Effect of Repetitive Doses of Succinylcholine and Thiopental Sodium on the Duration and Severity of Seizure in Electro Convulsive Therapy: Randomized Clinical Trial

2019 ◽  
pp. 1-8
Author(s):  
Farhad Nanaei ◽  
Hadi Bahrami ◽  
Aziz Kasani
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Initial Dose ◽  
Psychiatric Ward ◽  
Convulsive Therapy ◽  
Treatment Groups ◽  
Significant Difference ◽  
Thiopental Sodium ◽  
Hypnotic Drugs

Background and Aim: Regarding the controversial results on the effects of anesthetics, especially thiopental sodium, on the duration and severity of seizure and the lack of adequate information on the use of doses of anesthetic and paralysing drugs during ECT, this study was designed to determine the effect of repetitive doses of succinylcholine and Thiopental sodium was administered on the duration and severity of seizure during ECT. Materials and Methods: The present study was a one-blind randomized clinical trial on patients admitted to the psychiatric ward of Dezful Ganjavian Hospital. The research samples were selected after informed consent and entry criteria. Then, the samples were randomly assigned to two groups. In one group, succinylcholine dose was repeated (one third of the initial dose), and in the other group, the dose of thiopental sodium was repeated (one third of the initial dose). In all patients, seizure duration based on EEG monitoring and severity of seizure was determined by the psychiatrist based on the symptoms of the patient during seizure. Results: There was a significant difference between the quality of seizure in the two treatment groups after the intervention. There was a strong and good seizure in the thiopental sodium group (p <0.0001). There was a significant difference between the variables of seizure status in comparison with the previous shock in the two treatment groups after the intervention (p <0.0001). The duration of seizure was higher in thiopental sodium treatment group, but no significant difference was observed (p = 0.82). Conclusion: The results of this study showed that the duration and quality of seizure was better in patients requiring repetitive doses of hypnotic drugs (Thiopental Sodium), which was used to repeat the dose of muscle relaxant (succinylcholine).

scholarly journals A randomized clinical trial of chlorambucil versus COP in stage B chronic lymphocytic leukemia. The French Cooperative Group on Chronic Lymphocytic Leukemia

Blood ◽  
1990 ◽  
Vol 75 (7) ◽  
pp. 1422-1425 ◽  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Chronic Lymphocytic Leukemia ◽  
Randomized Clinical Trial ◽  
Survival Rates ◽  
Lymphocytic Leukemia ◽  
Cooperative Group ◽  
Survival Times ◽  
Treatment Groups ◽  
Significant Difference

In 1980, the French Cooperative Group on Chronic Lymphocytic Leukemia started a randomized clinical trial in which intermediate prognosis patients (stage B) received either an indefinite course of chlorambucil (0.1 mg/kg/d) or 12 cycles of the COP regimen (vincristine, cyclophosphamide, and prednisone). We present the results of the third interim analysis based on 291 patients (151 in the chlorambucil group and 140 in the COP group) with a mean follow-up of 53 months at the reference date of June 1, 1987. At this date, 129 deaths were observed, 65 in the chlorambucil group and 64 in the COP group; there was no improvement in overall survival with the COP regimen (P = .44) even after adjusting for both prognostic and imbalanced factors (P = .24). The 3-year and 5-year overall survival rates were, respectively, 69% and 44% in the chlorambucil group as compared with 73% and 43% in the COP group. The median survival times were 58 months in the chlorambucil group and 57 months in the COP group. Moreover, no significant difference was observed between the two treatment groups in terms of either treatment response, 9-month status, time to disease progression to stage C, or causes of death.

Adjunctive Triamcinolone Acetonide for Ahmed Glaucoma Valve Implantation: A Randomized Clinical Trial

2016 ◽  
Vol 27 (4) ◽  
pp. 411-416 ◽  
Author(s):  
Shahin Yazdani ◽  
Azadeh Doozandeh ◽  
Mohammad Pakravan ◽  
Vahid Ownagh ◽  
Mehdi Yaseri
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Triamcinolone Acetonide ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Final Analysis ◽  
Ahmed Glaucoma Valve ◽  
Hypertensive Phase ◽  
The Difference ◽  
Valve Implantation

Purpose To evaluate the effect of intraoperative sub-Tenon injection of triamcinolone acetonide (TA) as an adjunct to Ahmed glaucoma valve (AGV) implantation. Methods In this triple-blind randomized clinical trial, 104 eyes with refractory glaucoma were randomly assigned to conventional AGV (non-TA group) or AGV with adjunctive triamcinolone (TA group). In the TA group, 10 mg TA was injected in the sub-Tenon space around the AGV plate intraoperatively. Patients were followed for 1 year. The main outcome measure was intraocular pressure (IOP). Other outcome measures included best-corrected visual acuity (BCVA), occurrence of hypertensive phase (HP), peak IOP, number of antiglaucoma medications, and complications. Results A total of 90 patients were included in the final analysis. Mean IOP was lower in the TA group at most follow-up visits; however, the difference was statistically significant only at the first month (p = 0.004). Linear mixed model showed that mean IOP was 1.5 mm Hg lower in the TA group throughout the study period (p = 0.006). Peak postoperative IOP was significantly lower in the TA group (19.3 ± 4.8 mm Hg versus 29 ± 9.2 mm Hg, p = 0.032). Rates of success (defined as 6 < IOP <21 mm Hg) were similar in both groups at 12 months. There was no difference in the occurrence of the HP between the 2 groups (p = 0.123). Loss of BCVA >2 lines was more common in the non-TA group (p = 0.032). Conclusions Adjunctive intraoperative TA injection during AGV implantation can blunt peak IOP levels and reduce mean IOP up to 1 year. Visual outcomes also seem to be superior to standard surgery.

Randomized Trial of Silver Nitrate with Sodium Fluoride for Caries Arrest

2019 ◽  
Vol 4 (2) ◽  
pp. 126-134 ◽  
Author(s):  
S.S. Gao ◽  
D. Duangthip ◽  
M.C.M. Wong ◽  
E.C.M. Lo ◽  
C.H. Chu
Keyword(s):  
Clinical Trial ◽  
Preschool Children ◽  
Silver Nitrate ◽  
Randomized Clinical Trial ◽  
Sodium Fluoride ◽  
Silver Diamine Fluoride ◽  
Group A ◽  
The Mean ◽  
The Difference ◽  
Group B

Objectives: The aim of this noninferiority double-blind randomized clinical trial was to compare the effectiveness of the topical semiannual application of a 25% silver nitrate (AgNO3) solution followed by a 5% sodium fluoride (NaF) varnish with that of a 38% silver diamine fluoride (SDF) solution in arresting caries among preschool children. Methods: Healthy 3-y-old children with active dentine carious lesions were randomly allocated to 2 groups via computer-generated random numbers. Lesions in group A received applications of a 25% AgNO3 solution followed by a 5% NaF varnish semiannually (every 6 mo). Lesions in group B received semiannual applications of a 38% SDF solution followed by a placebo varnish. A trained examiner recorded the status of caries and oral hygiene at baseline and during follow-up examinations. The examiner, children, and their caretakers were blinded to the intervention allocation. This study adopted an intention-to-treat analysis. A noninferiority test was conducted for the data analysis. Group A’s noninferiority was accepted if the lower limit of the 95% CI for the difference in the mean number of arrested surfaces was >−0.5. Results: A total of 1,070 children were recruited at baseline, with 535 children in each group. After 18 mo, the mean ± SD number of arrested surfaces was 3.3 ± 3.4 in group A (n = 484) and 3.2 ± 3.5 in group B (n = 476; P = 0.664). The difference in the mean number of arrested surfaces between the groups was 0.092 (95% CI, −0.322 to 0.505). Apart from black staining on the arrested lesions, no other significant side effect was observed. Conclusion: A semiannual application of 25% AgNO3 followed by 5% NaF is no worse than a 38% SDF in arresting dentine caries among preschool children over 18 mo. The Hong Kong Research Grants Council (GRF 17107315) funded this trial, which was registered at ClinicalTrials.gov (NCT02019160). Knowledge Transfer Statement: This randomized clinical trial found that silver nitrate solution followed by sodium fluoride varnish is effective in arresting dentine caries among preschool children. As silver nitrate followed by sodium fluoride is a noninvasive and simple protocol, it can be an alternative strategy to manage dental caries among young children, especially in countries where silver diamine fluoride is not available.

scholarly journals Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jumara Martins ◽  
Ana Francisca Vaz ◽  
Regina Celia Grion ◽  
Lúcia Costa-Paiva ◽  
Luiz Francisco Baccaro
Keyword(s):  
Clinical Trial ◽  
Cervical Cancer ◽  
Randomized Clinical Trial ◽  
Open Label ◽  
Treatment Groups ◽  
Vaginal Stenosis ◽  
Significant Difference ◽  
Vaginal Dilators ◽  
The Mean ◽  
Topical Estrogen

Abstract Background We aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer. Methods open-label randomized clinical trial of 195 women, stage I-IIIB, aged 18–75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression. Results the mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period. There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p < 0.01), except for the users of vaginal dilator (p = 0.37). Conclusions there was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment. Trial registration Brazilian Registry of Clinical Trials, RBR-23w5fv. Registered 10 January 2017 - Retrospectively registered.

Sign in / Sign up

Export Citation Format

Share Document