Dataset Information

The VEPRO trial: a cross-over randomised controlled trial comparing 2 progressive lenses for patients with presbyopia.

ABSTRACT: The aim of this trial was to compare the effectiveness of two generations of progressive lenses for presbyopia.A multicenter cross-over randomized controlled trial performed in a primary care setting (5 optical dispensaries) was planned. Two categories of progressive lenses were compared: 1) a new-generation lens (i.e., VARILUX PANAMIC ORMA CRIZAL), which is expensive but a supposed improvement in comfort, and 2) an older-generation lens (i.e., VARILUX CONFORT ORMA CRIZAL), which is less expensive and is considered the reference lens. Patients were randomized to wear one generation of progressive lens for 4 weeks, then cross over to wear the other lens for 4 weeks, without knowing the sequence of lenses. Inclusion criteria were 1) age 43-60 years; 2) outpatients already wearing progressive lenses and referred to an optician ophthalmologist for optical correction prescription within the last 6 months; 3) receiving a correction of

SUBMITTER: Boutron I

PROVIDER: S-EPMC2556995 | biostudies-literature | 2008 Sep

REPOSITORIES: biostudies-literature

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The VEPRO trial: a cross-over randomised controlled trial comparing 2 progressive lenses for patients with presbyopia.

Boutron Isabelle I Touizer Caroline C Pitrou Isabelle I Roy Carine C Ravaud Philippe P

Trials 20080919

<h4>Unlabelled</h4>The aim of this trial was to compare the effectiveness of two generations of progressive lenses for presbyopia.<h4>Methods</h4>A multicenter cross-over randomized controlled trial performed in a primary care setting (5 optical dispensaries) was planned. Two categories of progressive lenses were compared: 1) a new-generation lens (i.e., VARILUX PANAMIC ORMA CRIZAL), which is expensive but a supposed improvement in comfort, and 2) an older-generation lens (i.e., VARILUX CONFORT ...[more]

PMID: 18803826

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Project description:ObjectivesPhysical exertion is a high-risk activity for aerosol emission of respiratory pathogens. We aimed to determine the safety and tolerability of healthy young adults wearing different types of face mask during moderate-to-high intensity exercise.DesignCross-over randomised controlled study, completed between June 2021 and January 2022.ParticipantsVolunteers aged 18-35 years, who exercised regularly and had no significant pre-existing health conditions.InterventionsComparison of wearing a surgical, cloth and filtering face piece (FFP3) mask to no mask during 4×15 min bouts of exercise. Exercise was running outdoors or indoor rowing at moderate-to-high intensity, with consistency of distance travelled between bouts confirmed using a smartphone application (Strava). Each participant completed each bout in random order.OutcomesThe primary outcome was change in oxygen saturations. Secondary outcomes were change in heart rate, perceived impact of face mask wearing during exercise and willingness to wear a face mask for future exercise.ResultsAll 72 volunteers (mean age 23.9) completed the study. Changes in oxygen saturations did not exceed the prespecified non-inferiority margin (2% difference) with any mask type compared with no mask. At the end of exercise, the estimated average difference in oxygen saturations for cloth mask was -0.07% (95% CI -0.39% to 0.25%), for surgical 0.28% (-0.04% to 0.60%) and for FFP3 -0.21% (-0.53% to 0.11%). The corresponding estimated average difference in heart rate for cloth mask was -1.20 bpm (95% CI -4.56 to 2.15), for surgical 0.36 bpm (95% CI -3.01 to 3.73) and for FFP3 0.52 bpm (95% CI -2.85 to 3.89). Wearing a face mask caused additional symptoms such as breathlessness (n=13, 18%) and dizziness (n=7, 10%). 33 participants broadly supported face mask wearing during exercise, particularly indoors, but 22 were opposed.ConclusionThis study adds to previous findings (mostly from non-randomised studies) that exercising at moderate-to-high intensity wearing a face mask appears to be safe in healthy, young adults.Trial registration numberNCT04932226.

Project description:BackgroundText messaging systems are used to collect data on symptom prevalence. Using a text messaging system, we evaluated the effects of question load, question frequency, and financial incentive on response rates and reported infant diarrhoea rates in an infant diarrhoea survey.MethodsWe performed a factorial cross-over randomised controlled trial of an SMS surveying system for infant diarrhoea surveillance with treatments: financial incentive (yes/no), question load (1-question/3-question), and questioning frequency (daily/fortnightly). Participants progressed through all treatment combinations over eight two-week rounds. Data were analysed using multivariable logistic regressions to determine the impacts of the treatments on the response rates and reported diarrhoea rates. Attitudes were explored through qualitative interviews.ResultsFor the 141 participants, the mean response rate was 47%. In terms of percentage point differences (ppd), daily questioning was associated with a lower response rate than fortnightly (- 1·2[95%CI:-4·9,2·5]); high (3-question) question loads were associated with a lower response rate than low (1-question) question loads (- 7·0[95%CI:- 10·8,-3·1]); and financial incentivisation was associated with a higher response rate than no financial incentivisation (6·4[95%CI:2·6,10·2]). The mean two-week diarrhoea rate was 36·4%. Daily questioning was associated with a higher reported diarrhoea rate than fortnightly (29·9[95%CI:22·8,36·9]); with little evidence for impact by incentivisation or question load.ConclusionsClose to half of all participants responded to the SMS survey. Daily questioning evoked a statistically higher rate of reported diarrhoea, while financial incentivisation and low (1-question) question loads evoked higher response rates than no incentive and high (3-question) question loads respectively.Trial registrationThe protocol was prospectively registered on ISRCTN on the 20th of March 2019 under number ISRCTN11410773 .

Dataset Information

The VEPRO trial: a cross-over randomised controlled trial comparing 2 progressive lenses for patients with presbyopia.

Publications

The VEPRO trial: a cross-over randomised controlled trial comparing 2 progressive lenses for patients with presbyopia.

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