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

NCT ID: NCT00635115

Last Updated: 2008-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2007-01-31

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.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

2

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Other Intervention Names

VARILUX PANAMIC ORMA CRIZAL; Essilor (R); VARILUX COMFORT ORMA CRIZAL; Essilor (R)

Eligibility 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

• Minimum Eligible Age: 43 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santéclair

OTHER

Sponsor Role: lead

Locations

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

Countries

France

References

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.

Reference Type: DERIVED

PMID: 18803826 (View on PubMed)

Other Identifiers

FFSA-2005-01

Identifier Type: -

Identifier Source: org_study_id