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Completed

NCT Number: NCT00635115

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

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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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

43 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Other names: VARILUX PANAMIC ORMA CRIZAL, Essilor (R)

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

Device

Other names: VARILUX COMFORT ORMA CRIZAL, Essilor (R)

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

Sponsors and collaborators

Lead sponsor

Santéclair

Other

Registry information

Acronym: VEPRO

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 13, 2008
Registry last updated
Mar 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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