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Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia.

ABSTRACT: There is a major lack of randomized controlled clinical trials evaluating the efficacy of prismatic treatments for hemianopia. Evidence for their effectiveness is mostly based on anecdotal case reports and open-label evaluations without a control condition.To evaluate the efficacy of real relative to sham peripheral prism glasses for patients with complete homonymous hemianopia.Double-masked, randomized crossover trial at 13 study sites, including the Peli laboratory at Schepens Eye Research Institute, 11 vision rehabilitation clinics in the United States, and 1 in the United Kingdom. Patients were 18 years or older with complete homonymous hemianopia for at least 3 months and without visual neglect or significant cognitive decline.Patients were allocated by minimization into 2 groups. One group received real (57-prism diopter) oblique and sham (<5-prism diopter) horizontal prisms; the other received real horizontal and sham oblique, in counterbalanced order. Each crossover period was 4 weeks.The primary outcome was the overall difference, across the 2 periods of the crossover, between the proportion of participants who wanted to continue with (said yes to) real prisms and the proportion who said yes to sham prisms. The secondary outcome was the difference in perceived mobility improvement between real and sham prisms.Of 73 patients randomized, 61 completed the crossover. A significantly higher proportion said yes to real than sham prisms (64% vs 36%; odds ratio, 5.3; 95% CI, 1.8-21.0). Participants who continued wear after 6 months reported greater improvement in mobility with real than sham prisms at crossover end (P =?.002); participants who discontinued wear reported no difference.Real peripheral prism glasses were more helpful for obstacle avoidance when walking than sham glasses, with no differences between the horizontal and oblique designs. Peripheral prism glasses provide a simple and inexpensive mobility rehabilitation intervention for hemianopia.clinicaltrials.gov Identifier: NCT00494676.

SUBMITTER: Bowers AR

PROVIDER: S-EPMC3945165 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia.

Bowers Alex R AR Keeney Karen K Peli Eli E

JAMA ophthalmology 20140201 2

<h4>Importance</h4>There is a major lack of randomized controlled clinical trials evaluating the efficacy of prismatic treatments for hemianopia. Evidence for their effectiveness is mostly based on anecdotal case reports and open-label evaluations without a control condition.<h4>Objective</h4>To evaluate the efficacy of real relative to sham peripheral prism glasses for patients with complete homonymous hemianopia.<h4>Design, setting, and participants</h4>Double-masked, randomized crossover tria ...[more]

PMID: 24201760

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Project description:PurposeThe aim of the study was to investigate the effects of the Allergan Intranasal Tear Neurostimulator (ITN) on conjunctival goblet cell (GC) degranulation.DesignA randomized, double-masked, placebo-controlled crossover trial.MethodsA total of 15 subjects (5 normal and 10 dry eye) were enrolled in a 3-visit study consisting of 1 screening and 2 separate randomized-masked ITN treatments (sham extranasal or intranasal). Tear meniscus height (TMH) was measured by anterior segment optical coherence tomography before and after applications. Impression cytology (IC) was taken from the bulbar conjunctiva of the right eye for periodic acid-Schiff staining and from the left eye for MUC5AC mucin immunostaining at baseline and after each treatment. The ratio of degranulated to nondegranulated GCs was measured as a marker of secretion.ResultsIn all participants, both inferior bulbar (IB) and temporal bulbar (TB) cytology specimens stained for MUC5AC revealed a significantly higher ratio of degranulated to nondegranulated GCs after the ITN (IB: 2.28 ± 1.27 and TB: 1.81 ± 1.01) compared to baseline (IB: 0.56 ± 0.55, P = .015) (TB: 0.56 ± 0.32, P = .003) and extranasal sham application (IB: 0.37 ± 0.29, P = .001) (TB: 0.39 ± 0.33, P = .001). When the same analysis was repeated in the dry eye or control groups, the ratio was significantly higher after ITN than the baseline ratio and ratio after extranasal application in both groups (P < .05). Moreover, although control subjects had a higher ratio of degranulated to nondegranulated GCs at baseline (0.75 ± 0.52) compared with the dry eye group (0.41 ± 0.27), the ratio became slightly higher in dry eye (2.04 ± 1.12 vs 1.99 ± 1.21 in control) after the ITN application. There was no significant difference between the IB or TB conjunctiva locations in terms of the effectiveness of the ITN application on conjunctival goblet cell secretory response.ConclusionsThese preliminary results document that the Allergan ITN can stimulate degranulation of goblet cells in the conjunctiva, which is a promising new approach for the management of dry eye.

Project description:BackgroundCentral obesity is considered as a significant health threat to individuals. Scientific research has demonstrated that intra-abdominal fat accumulation is associated with higher metabolic and cardiovascular disease risks independent of Body Mass Index (BMI). This study aimed to evaluate the efficacy and safety of electro-acupuncture in treating central obesity compared with sham acupuncture.MethodThis was a patient-assessor blinded, randomized, sham-controlled clinical trial. One hundred sixty eight participants aged between 18 and 65 years old with BMI ≥ 25 kg/m2 and waist circumference (WC) of men ≥ 90 cm / women ≥ 80 cm were enrolled and allocated to the acupuncture or sham acupuncture group equally. For the acupuncture group, disposable acupuncture needles were inserted into eight body acupoints, including Tianshu (ST-25), Daheng (SP-15), Daimai (GB-26), Qihai (CV-6), Zhongwan (CV-12), Zusanli (ST-36), Fenglong (ST-40), and Sanyinjiao (SP-6) with electrical stimulation. For the control group, Streitberger's non-invasive acupuncture needles were utilized at the same acupoints with identical stimulation modalities. The treatment duration was 8 weeks with 2 sessions per week and the follow-up period was 8 weeks. The primary outcome was the change in WC before and after the treatment. The secondary outcomes were the changes in hip circumference, waist-to-hip circumference ratio, BMI, and body fat percentage during the treatment and follow-up period.ResultsThe acupuncture group displayed a significant change in WC compared to the sham group both treatment and follow-up period (MD = -1.1 cm, 95% CI = -2.8 to 4.1). Significant change in body fat percentage was recorded for both groups after treatment but no significance was observed during the follow-up period (MD = -0.1%, 95% CI = -1.9 to 2.2). The changes in hip circumference were also significant both treatment and follow-up period for the acupuncture group (MD = -2.0 cm, 95% CI = -3.7 to -1.7). Compared with sham acupuncture, the body weight (MD = -1 kg, 95% CI = -3.3 to 5.3), BMI (MD = -0.5, 95% CI = -0.7 to 1.9) also decreased significantly within and between groups. The incidence of adverse events was similar in the two groups.ConclusionThis study provided evidence that electro-acupuncture could be effective in treating central obesity by reducing WC, hip circumference, body weight, BMI, and waist-to-hip circumference ratio.Trial registrationClinicalTrials.gov Identifier: NCT03815253, Registered 24 Jan 2019.

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Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia.

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Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia.

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