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

Presbyopia Clinical Trial

— VEPRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635115
• Other study ID #: FFSA-2005-01
• Status: Completed
• Phase: N/A
• First received: March 6, 2008
• Last updated: March 12, 2008
• Start date: February 2006
• Est. completion date: January 2007

Study information

• Verified date: March 2008
• Source: Santéclair
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 43 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Presbyopia

Intervention

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

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

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Santéclair

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient preference for a corrective lens		8 weeks	No
Secondary	subjective measures of different areas of visual performance.		8 weeks	No