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

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
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)
Sponsored by
Santéclair
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

43 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

patient preference for a corrective lens

Secondary Outcome Measures

subjective measures of different areas of visual performance.

Full Information

First Posted
March 6, 2008
Last Updated
March 12, 2008
Sponsor
Santéclair
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1. Study Identification

Unique Protocol Identification Number
NCT00635115
Brief Title
The VEPRO Trial: A Cross-Over Randomised Controlled Trial Comparing 2 Corrective Lenses for Patients With Presbyopia
Acronym
VEPRO
Official Title
The VEPRO Trial: A Cross-Over Randomised Controlled Trial Comparing 2 Corrective Lenses for Patients With Presbyopia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Santéclair

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal)
Other Intervention Name(s)
VARILUX PANAMIC ORMA CRIZAL, Essilor (R)
Intervention Type
Device
Intervention Name(s)
an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal)
Other Intervention Name(s)
VARILUX COMFORT ORMA CRIZAL, Essilor (R)
Primary Outcome Measure Information:
Title
patient preference for a corrective lens
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
subjective measures of different areas of visual performance.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
43 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
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
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18803826
Citation
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.
Results Reference
derived

Learn more about this trial

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

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