PresbyopiaVEPRONCT00635115
The VEPRO Trial: A Cross-Over Randomised Controlled Trial Comparing 2 Corrective Lenses for Patients With Presbyopia
A study testing a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal) and an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal) in people with Presbyopia, run by Santéclair at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 43 to 60 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal) and an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2006to Jan 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 43 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- first prescription of corrective lenses for presbyopia
- associated strabism
- associated amblyopia
- orthoptics therapy
- associated anisometropia > 1.5 dioptres
- patients treated for diabetes
Trial locations and contacts
1 site in 1 country.
France1 site
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
About this study
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
- Being tested
- 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)
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal)Device
Also called VARILUX PANAMIC ORMA CRIZAL, Essilor (R)
an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal)Device
Also called VARILUX COMFORT ORMA CRIZAL, Essilor (R)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal) |
| 2 | Active comparator | Not described Receives: Device: an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient preference for a corrective lens
Measured: 8 weeks
Secondary outcomes (1)
subjective measures of different areas of visual performance.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startFeb 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santéclair
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635115
- Sponsor's protocol ID
- FFSA-2005-01
- Acronym
- VEPRO
- Status last verified
- Mar 2008
- First submitted
- 6 Mar 2008
- Last updated
- 13 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18803826
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VEPRO Trial: A Cross-Over Randomised Controlled Trial Comparing 2 Corrective Lenses for Patients With Presbyopia
- ClinicalTrials.gov ID
- NCT00635115
- Acronym / sponsor ID
- VEPRO / FFSA-2005-01
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- SantéclairUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 43 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- first prescription of corrective lenses for presbyopia
- associated strabism
- associated amblyopia
- orthoptics therapy
- associated anisometropia > 1.5 dioptres
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal)Also: VARILUX PANAMIC ORMA CRIZAL, Essilor (R) | Device | 1 |
| an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal)Also: VARILUX COMFORT ORMA CRIZAL, Essilor (R) | Device | 2 |
Primary outcome
patient preference for a corrective lens
Time frame: 8 weeks
1 secondary outcome
subjective measures of different areas of visual performance.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2008.
- Derived from this study: PubMed 18803826Boutron 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal) and an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal) in people with Presbyopia, run by Santéclair at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient preference for a corrective lens (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00635115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2008.