PresbyopiaNCT01933750
Trial of the PresView Implant for the Improvement of Near Vision in Presbyopic Patients
A study testing PresVIEW Device Implantation in people with Presbyopia, run by Refocus Ocular Europe, B.V. at 1 site in United Kingdom.
Trial summary
Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision in patients who require reading glasses Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- PresVIEW Device Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Mar 2016
- 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 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 45 or older at commencement of study
- Best Corrected Distance Visual Acuity of .80 (20/25) or better
- Patients must be alert, mentally competent, and able to comply with clinical study requirements
Who cannot join
- Any previous eye surgeries including cataract, LASIK (laser in situ keratomileusis), or eye muscle surgery
- Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.
- Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Controlled Clinical Study of the PresVIEW Scleral Implant for the Improvement of Near Visual Acuity in Presbyopic Patients
Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision in patients who require reading glasses
- Conditions
- Presbyopia
- Being tested
- PresVIEW Device Implantation
- Keywords
- Presbyopia, Reading Glasses, Near Vision
- Medical subject headings
- Presbyopia, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PresVIEW Device ImplantationDevice
| Study group | Role | What they receive |
|---|---|---|
| Randomized/Control | No intervention | 7 patients randomized to deferred treatment/control cohort at the 3 sub-study control sites = 21 |
| Non-Randomized/Treatment | Experimental | Patients are non-randomized and if meet inclusion criteria receive the implantation of the PresVIEW device Receives: Device: PresVIEW Device Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near Visual Acuity
Measurement of the distance Corrected Near Visual Acuity at 40 centimeters compared to baseline measurement. A minimum of 75% of patients with a bilateral post-operative Distance Corrected Near Visual Acuity of .5 (20/40) or better at 12 months
Measured: 12 Months
Secondary outcomes (2)
Uncorrected Near Visual Acuity
The percent of patients with a bilateral post-operative uncorrected near visual acuity (UCNVA) at 40 centimeters of .5 (20/40) or better at 12 months
Measured: 12 Months
Presence of Significant Safety Events
Several indicators of safety are monitored including but not limited to Best Corrected Distance Visual Acuity, Intra-ocular Pressure, and Chronic Inflammation.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Refocus Ocular Europe, B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933750
- Sponsor's protocol ID
- EU-001
- Status last verified
- Apr 2016
- First submitted
- 28 Aug 2013
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Controlled Clinical Study of the PresVIEW Scleral Implant for the Improvement of Near Visual Acuity in Presbyopic Patients
- ClinicalTrials.gov ID
- NCT01933750
- Acronym / sponsor ID
- EU-001
- Conditions
- Presbyopia
- Keywords
- Presbyopia, Reading Glasses, Near Vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Refocus Ocular Europe, B.V.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Sep 2013 (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.
Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision in patients who require reading glasses
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized/Control | No intervention | –7 patients randomized to deferred treatment/control cohort at the 3 sub-study control sites = 21 |
| Non-Randomized/Treatment | Experimental | Device: PresVIEW Device ImplantationPatients are non-randomized and if meet inclusion criteria receive the implantation of the PresVIEW device |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 45 or older at commencement of study
- Best Corrected Distance Visual Acuity of .80 (20/25) or better
- Patients must be alert, mentally competent, and able to comply with clinical study requirements
Key exclusion criteria (3 listed)
- Any previous eye surgeries including cataract, LASIK (laser in situ keratomileusis), or eye muscle surgery
- Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.
- Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases
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 |
|---|---|---|
| PresVIEW Device Implantation | Device | Non-Randomized/Treatment |
Primary outcome
Near Visual Acuity
Time frame: 12 Months
Measurement of the distance Corrected Near Visual Acuity at 40 centimeters compared to baseline measurement. A minimum of 75% of patients with a bilateral post-operative Distance Corrected Near Visual Acuity of .5 (20/40) or better at 12 months
2 secondary outcomes
Uncorrected Near Visual Acuity
Time frame: 12 Months
Presence of Significant Safety Events
Time frame: 24 months
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 6 Apr 2016.
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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 PresVIEW Device Implantation in people with Presbyopia, run by Refocus Ocular Europe, B.V. at 1 site in United Kingdom.
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 3 inclusion and 3 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 6 Apr 2016. 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 United Kingdom. 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?
Near Visual Acuity (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2016.