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

Santéclair

Status: Completed

Conditions: Presbyopia

Treatments: 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)

Study type: Interventional

Funder types: Other

Identifiers

NCT00635115

FFSA-2005-01

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 43 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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127 participants in 2 patient groups

1

Experimental group

Treatment:

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

2

Active Comparator group

Treatment:

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