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CompletedNCT00635115VEPROUpdated Mar 13, 2008

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

An interventional study of a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal) and an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal) in Presbyopia, sponsored by Santéclair. Completed at 1 site in France. Open to participants aged 43 Years to 60 Years. Per ClinicalTrials.gov, last updated 2008-03-13.

Sponsored by Santéclair · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
43 Years to 60 Years
Sex
All
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Study 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.

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Conditions studied

  • Presbyopia

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03

In context

Presbyopia

330 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's enrollment of 127 is above the median of 60 across 271 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

This is the only study on the registry with Santéclair as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
43 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • first prescription of corrective lenses for presbyopia
  • associated strabism
  • associated amblyopia
  • orthoptics therapy
  • associated anisometropia > 1.5 dioptres
  • patients treated for diabetes
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
127 participants (actual)

Study arms

  • Experimental
    1

    Device: a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal)

  • Active comparator
    2

    Device: an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal)

Interventions

  • Devicea new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal)

    Also known as: VARILUX PANAMIC ORMA CRIZAL, Essilor (R)

  • Devicean old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal)

    Also known as: VARILUX COMFORT ORMA CRIZAL, Essilor (R)

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What researchers measure

Primary outcomes

  1. patient preference for a corrective lens

    Time frame: 8 weeks

Secondary outcomes

  1. subjective measures of different areas of visual performance.

    Time frame: 8 weeks

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Study locations

1 site
  • 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, 75018, France
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References and documents

Publications

  • Boutron I, Touizer C, Pitrou I, Roy C, Ravaud P. The VEPRO trial: a cross-over randomised controlled trial comparing 2 progressive lenses for patients with presbyopia. Trials. 2008 Sep 19;9:54. doi: 10.1186/1745-6215-9-54. PubMed 18803826 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00635115
Lead sponsor
Santéclair
First posted
Mar 13, 2008
Start date
Feb 2006
Primary completion
Jan 2007
Completion
Jan 2007
Last update
Mar 13, 2008

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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