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The VEPRO Trial: A Cross-Over Randomised Controlled Trial Comparing 2 Corrective Lenses for Patients With Presbyopia (VEPRO)

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ClinicalTrials.gov Identifier: NCT00635115
Recruitment Status : Completed
First Posted : March 13, 2008
Last Update Posted : March 13, 2008
Sponsor:
Information provided by:
Santéclair

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Presbyopia Device: a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal) Device: an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The VEPRO Trial: A Cross-Over Randomised Controlled Trial Comparing 2 Corrective Lenses for Patients With Presbyopia
Study Start Date : February 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Device: a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal)
Other Names:
  • VARILUX PANAMIC ORMA CRIZAL
  • Essilor (R)
Active Comparator: 2 Device: an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal)
Other Names:
  • VARILUX COMFORT ORMA CRIZAL
  • Essilor (R)


Outcome Measures
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Primary Outcome Measures :
  1. patient preference for a corrective lens [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. subjective measures of different areas of visual performance. [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   43 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635115


Locations
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France
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
Paris, France, 75018
Sponsors and Collaborators
Santéclair
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00635115    
Other Study ID Numbers: FFSA-2005-01
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: March 13, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases