Dataset Information

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

ACCESS DATA

Publications

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

Similar Datasets

Project description:Importance:Tear film breakup time assessment is an integral component of dry eye evaluation. To our knowledge, the comparative discriminative ability of the noninvasive Keratograph (Oculus) vs conventional fluorescein method in detecting dry eye is unknown. Objective:To compare tear film stability measurements obtained with an automated noninvasive corneal topographer vs conventional fluorescein methods and evaluate their respective discriminative ability in detecting dry eye. Design, Setting, and Participants:This investigator-masked randomized crossover trial was conducted at a single-center university clinic between May 26, 2016, and October 3, 2016, and included 74 participants 18 years or older. Participants were recruited into 2 equally sized age, sex, and race/ethnicity-matched groups, with and without symptomatic dry eye (Ocular Surface Disease Index ?13). Interventions:Participants were assigned to receive a noninvasive keratograph evaluation and topical fluorescein instillation in a randomized order. Main Outcomes and Measures:Noninvasive keratograph breakup time (NIKBUT) and fluorescein breakup time (TBUT). Area under the receiver operating characteristic curve, Youden-optimal diagnostic cutoff sensitivity, and specificity of NIKBUT and TBUT in detecting dry eye. Results:Seventy-four participants (74 eyes; 43 women [58.1%]) with a mean (SD) age of 24 (4) years were randomized. Noninvasive keratograph breakup time was significantly longer than TBUT in participants with dry eye (median, 6.3 seconds vs 4.3 seconds [difference, 2.0 seconds]; 95% CI, 1.1-3.4 seconds; P?=?.003), and healthy participants (median, 11.9 seconds vs 5.0 seconds [difference, 6.9 seconds]; 95% CI, 4.7-7.6 seconds; P?<?.001). Fluorescein breakup time measurements were more narrowly distributed in both the dry eye (variance, 188 seconds2 vs 27.9 seconds2; P?<?.001) and control groups (variance, 113 seconds2 vs 13.4 seconds2; P?<?.001). The discriminative ability of NIKBUT in detecting dry eye (area under the receiver operating characteristic curve, 0.68; 95% CI, 0.56-0.81; P?=?.007) was greater than that of TBUT (area under the receiver operating characteristic curve, 0.57; 95% CI, 0.44-0.70; P?=?.31). The optimal diagnostic cutoff for NIKBUT was 9 seconds or less with a sensitivity of 68% (95% CI, 50%-82%), specificity of 70% (95% CI, 53%-84%), positive likelihood ratio of 2.27 (95% CI, 1.32-3.91), and negative likelihood ratio of 0.46 (95% CI, 0.28-0.77). The optimal threshold for TBUT was 5 seconds or less with a sensitivity of 54% (95% CI, 37%-71%), specificity of 68% (95% CI, 50%-82%), positive likelihood ratio of 1.67 (95% CI, 0.96-2.89), and negative likelihood ratio of 0.68 (95% CI, 0.45-1.03). Conclusions and Relevance:Conventional fluorescein tear film breakup time measurements were significantly shorter with narrower distributions, while automated noninvasive keratograph readings displayed superior discriminative ability in detecting dry eye. Trial Registration:anzctr.org.au Identifier: ACTRN12617001428358.

Project description:The aim of the study was to investigate the effects of the Allergan Intranasal Tear Neurostimulator (ITN) on conjunctival goblet cell (GC) degranulation.A randomized, double-masked, placebo-controlled crossover trial.A 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.In 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.These 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:BACKGROUND:Chronic low back pain (CLBP) is the most common chronic pain condition and is often resistant to conventional treatments. Acupuncture is a popular alternative for treating CLBP but its mechanisms of action remain poorly understood. Evidence suggests that pain regulatory mechanisms (particularly the ascending and secondarily the descending pain modulatory pathways) and psychological mechanisms (e.g., expectations, pain catastrophizing and self-efficacy) may be involved in the pathogenesis of CLBP and its response to treatments. We will examine these mechanisms in the treatment of CLBP by electroacupuncture (EA). METHODS:We present the aims and methods of a placebo-controlled, participant-blinded and assessor-blinded mechanistic study. Adult patients with CLBP will be randomized to receiving 16 sessions of real (active) or sham (placebo) EA over the course of 8?weeks. The primary pain regulatory measure for which the study was powered is temporal summation (TS), which approximates ascending pain facilitation. Conditioned pain modulation (CPM), representing a descending pain modulatory pathway, will be our secondary pain regulatory measure. The primary psychological measure is expectations of benefit, and the secondary psychological measures are pain catastrophizing and self-efficacy in managing pain. Main clinical outcomes are back pain bothersomeness on a 0-100 visual analog scale (primary), Roland Morris Disability Questionnaire (secondary), and relevant items from the National Institutes of Health (NIH) Patient-Reported Outcome Measures Information System (secondary). We hypothesize that compared to sham, real EA will lead to greater reduction in TS after 8 treatment sessions (4?weeks); and that reduction in TS (and secondarily, increase in CPM) after 8 treatment sessions will mediate reduction in back pain bothersomeness from baseline to week 10 (clinical response) to EA. We also hypothesize that the three psychological factors are moderators of clinical response. With 100 treatment completers, the study is designed to have 80% power to detect a medium-sized between-group effect (d =?0.5) on temporal summation. DISCUSSION:To the best of our knowledge, this is the first appropriately powered, placebo-controlled clinical trial evaluating mechanisms of EA in the treatment of CLBP. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02503475 . Registered on 15 July 15 2015. Retrospectively registered.

Project description:BACKGROUND:Approximately 50 to 70% of post-stroke subjects present a reduction in the upper limb (UL) function even during the chronic phase. An adjuvant technique widely used in neurorehabilitation is elastic taping applications. However, its efficacy in UL treatment for post-stroke subjects still requires further investigation. OBJECTIVE:To verify the effects of elastic tape (ET) used on the paretic shoulder in upper limb (UL) performance during a drinking task. METHOD:A single-center randomized sham-controlled crossover trial randomized thirteen post-stroke subjects with mild to moderate UL impairment for group allocation to receive first Sham Tape (ST) or first Elastic Tape (ET), with one month of washout. Kinematic measures of a drinking task were taken before and after each intervention (elastic and sham tape), using Three-Dimensional Motion Analysis, and studied using feature analysis and Statistical Parametric Mapping. Outcome measures included spatiotemporal variables, scalar kinematic parameters (starting angles, range of motion-ROM, and endpoint angles) and time-normalized kinematic waveforms of trunk and UL joint angles (scapulothoracic, humerothoracic and elbow). RESULTS:Elastic tape provided common modifications throughout the task (shoulder more towards midline, reduced scapula protraction and trunk flexion) and important alterations at specific time-instants. At the end of the reaching phase, for both groups (ET and ST), the elastic tape increased elbow extension [ET: CI = 12.57 (6.90 to 18.17), p<0.001; ST: CI: 12.89 (6.79 to 18.98), p<0.001). At the end of transporting the glass to the mouth, patients who underwent the elastic tape intervention presented more shoulder elevation [ET: CI = 16.40 (4.28 to 28.52), p = 0.007; ST: CI: 15.13 (5.79 to 24.48), p = 0.002)]. Moreover, an increase of elbow extension at the end of transporting the glass to the table was observed for both groups [ET: CI = 8.13 (1.48 to 14.79), p = 0.014; ST: CI: 8.20 (4.03 to 12.38), p<0.001)]. However, no changes in the spatiotemporal parameters were observed for both groups during all the phases of the task (p>0.05). CONCLUSION:The ET changed UL joint motions and posture during a drinking task in chronic hemiparetic subjects, which defines its role as an adjuvant therapy.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets