- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00635115
The VEPRO Trial: A Cross-Over Randomised Controlled Trial Comparing 2 Corrective Lenses for Patients With Presbyopia (VEPRO)
March 12, 2008 updated by: Santéclair
The VEPRO trial is a cross-over randomised controlled trial comparing 2 corrective lenses for patients with presbyopia.
The aim of the study is to compare the effectiveness of two corrective lenses: an old generation (Varilux Comfort Orma Crizal) and a new generation (Varilux Panamic Orma Crizal) of corrective lenses prescribed in presbyopia.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
127
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75018
- INSERM, U738, Paris, France ; Université Paris 7 Denis Diderot, UFR de Médecine, Paris, France ; AP-HP, Hôpital Bichat, Département d'Epidémiologie, Biostatistique et Recherche Clinique
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
43 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 43 to 60 years old
- outpatients wearing corrective lenses for presbyopia, referred to an optician within the last 6 months for a change in their optical correction
- associated hyperopia or astigmatism, the required correction had to be ≤ 3 dioptres in that case
- understanding, speaking French and able to answer a questionnaire
Exclusion Criteria:
- first prescription of corrective lenses for presbyopia
- associated strabism
- associated amblyopia
- orthoptics therapy
- associated anisometropia > 1.5 dioptres
- patients treated for diabetes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Other Names:
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Active Comparator: 2
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
patient preference for a corrective lens
Time Frame: 8 weeks
|
8 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
subjective measures of different areas of visual performance.
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
March 6, 2008
First Submitted That Met QC Criteria
March 12, 2008
First Posted (Estimate)
March 13, 2008
Study Record Updates
Last Update Posted (Estimate)
March 13, 2008
Last Update Submitted That Met QC Criteria
March 12, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FFSA-2005-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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