NCT00635115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
Last Updated

March 13, 2008

Status Verified

March 1, 2008

Enrollment Period

11 months

First QC Date

March 6, 2008

Last Update Submit

March 12, 2008

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

  • patient preference for a corrective lens

    8 weeks

Secondary Outcomes (1)

  • subjective measures of different areas of visual performance.

    8 weeks

Study Arms (2)

1

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

2

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

Interventions

a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal)DEVICE
Also known as: VARILUX PANAMIC ORMA CRIZAL, Essilor (R)
1
an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal)DEVICE
Also known as: VARILUX COMFORT ORMA CRIZAL, Essilor (R)
2

Eligibility Criteria

Age43 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • first prescription of corrective lenses for presbyopia
  • associated strabism
  • associated amblyopia
  • orthoptics therapy
  • associated anisometropia \> 1.5 dioptres
  • patients treated for diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Location

Related Publications (1)

  • 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.

    PMID: 18803826DERIVED

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2008

First Posted

March 13, 2008

Study Start

February 1, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

March 13, 2008

Record last verified: 2008-03

Locations

FR(1)