PresbyopiaNCT01166568
Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia
A study testing PresVIEW Scleral Implants in people with Presbyopia, run by VisDura, Inc. at 14 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and effectiveness of the PresVIEW™ Scleral Implant (PSI) for the improvement of near visual acuity in presbyopic patients. Read more about this study
- Who is it for?
- Ages 50 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- PresVIEW Scleral Implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 14 sitesUnited States
- Study dates
- Dec 2003to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must be between 50-60 years old
- Subject must have a best corrected distance visual acuity of 20/20 or better
- Subject must have SLOAN distance corrected near visual acuity @ 40cm in the operative eye/eyes of 20/50 to 20/100 (inclusive).
- Subject should have a manifest distance spherical equivalent refractive correction in the operative eye/eyes of from -0.50 to +0.75 diopters with no more than 1.00 diopter of astigmatism and should require at least a +1.50 diopter add. The distance manifest refraction spherical equivalent and the distance cycloplegic refraction spherical equivalent must be within 0.50 diopters of each other.
- Subject must be phakic in the study eye
- Subject must be mentally competent to understand and comply with the requirements of the study.
- Subject must be able to provide written informed consent.
Who cannot join
- Chronic uveitis or other recurrent anterior or posterior segment inflammation in either eye.
- Scleral thickness less than 530 μm in the operative eye/eyes.
- Any previous eye surgeries including cataract, LASIK, or Muscle surgery
- Any history of prior extraocular muscle surgery, specifically the recti or oblique muscles.
- Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.
- Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases
- Allergic to any medications used in the study.
- The patient may not have participated in a device clinical study for the operative eye within the last 3 months and may not have been implanted with PSI devices in this or any other study.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Fichte, Endl and Elmer Eyecare Creekside Center
Amherst, New York, 14228
Boxer-Wachler Vision Institute
Beverly Hills, California, 90210
The Midwest Center for Sight
Des Plaines, Illinois, 60016
Southeastern Eye Center
Greensboro, North Carolina, 27410
Jacksoneye
Lake Villa, Illinois, 60046
Vision/Advanced Eye Center
Lombard, Illinois, 60148
The Eye Care Institute
Louisville, Kentucky, 40206
Wang Vision Institute
Nashville, Tennessee, 37203
Cornea Associates
Omaha, Nebraska, 68144
Braverman-Terry-Oei-Eye Associates
San Antonio, Texas, 78212
The Center for Corrective Eye Surgery
San Antonio, Texas, 78215
Gordon-Weiss-Schanzlin Vision Institute
San Diego, California, 92122
Associated Vision Consultants
Southfield, Michigan, 48034
Eye Associates of South Tulsa
Tulsa, Oklahoma, 74133
About this study
Official title: A Prospective, Multicenter Clinical Trial Of the PresVIEW Scleral Implant (PSI) For the Improvement Of Near Visual Acuity In Presbyopic Patients
The primary objective of this study is to evaluate the safety and effectiveness of the PresVIEW™ Scleral Implant (PSI) for the improvement of near visual acuity in presbyopic patients.
Read the detailed description
The clinical investigation of the PresView™ Scleral Implant (PSI) is a prospective multicenter clinical trial in which a total of 330 subjects were enrolled and implanted with the PSI and followed for a period of 24 months at up to 14 clinical sites.
An additional randomized sub-study was performed on 48 subjects with the PSI Second Generation PresView™(SGP) implant, model number SGP-046. A 2:1 randomization was used to determine the 32 subjects assigned to be implanted and the 16 subjects assigned to the observation/deferred implantation control arm. Subjects randomized to the deferred implantation control arm were eligible to receive the PSI after completion of the 6 months of observation in the study.
All subjects interested in participating in the study were screened for eligibility, and informed consent was obtained from those who meet the inclusion/exclusion criteria. Eligible subjects were examined preoperatively to obtain a medical history and baseline ocular data.
Effectiveness: The following tests/measurements used to evaluate the effectiveness of the PSI procedure will be included in the study protocol:
- Near visual acuity of the operated eye/eyes as compared with baseline (uncorrected and distance corrected)
- Reading acuity of the operated eye/eyes as compared with baseline (uncorrected and distance corrected)
The PSI procedure will be defined as successful if a logMar equivalent to Snellen 20/40 or better (logMar 0.3) is achieved in ≥ 75% of patients or if 75% of patients realize an improvement ≥ 2 lines in distance corrected near visual acuity (DCNVA). For most patients, this will translate into the ability to read the majority of newspaper and magazine print without a near optical aid.
Safety: Primary safety outcomes for safety will include:
- Incidence of anterior segment ischemia
- Decrease in Best Corrected Distance Visual Acuity (BCDVA) of more than 2 lines from baseline at 1-month or more postoperatively
- Decrease in best distance corrected near acuity (with add) of more than 2 lines from baseline at 1-month or more postoperatively
- Intraocular Pressure (IOP) increase > 10mm Hg over baseline or IOP > 25mm Hg after 1 Day postoperative
- Signs of chronic inflammation (e.g. uveitis or chronic conjunctival hyperemia) at 2 months or more postoperatively
- Increase in axial length of ≥ 0.20mm accompanied by a > 0.5 diopter myopic shift in manifest spherical equivalent distance refraction.
- Incidence of adverse events: total not to exceed 5%, and the incidence of each event should not exceed 1-2%
- Conditions
- Presbyopia
- Being tested
- PresVIEW Scleral Implants
- Keywords
- Presbyopia, Reading Vision, 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 Scleral ImplantsDevice
Subjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Implantation-Non Randomized | Experimental | Subjects are not participants in the randomized sub-study. PresView Scleral Implants surgical placed in the eye(s) after enrollment and meeting inclusion/exclusion criteria. Receives: Device: PresVIEW Scleral Implants |
| Implantation-Randomized | Experimental | Subjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. PresView Scleral Implants surgical placed in the eye(s)Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Receives: Device: PresVIEW Scleral Implants |
| Deferred Implantation-Randomized | No intervention | Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have PresView Scleral Implants surgically placed in the eye(s) and become part of the overall study experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines
Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better or improvement of 2 or more lines at 24 months for the primary eye.
Measured: From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.
Secondary outcomes (1)
Presence of Significant Safety Events (SAEs).
The point estimate were calculated for clinically significant adverse events (SAE's) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.
NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Measured: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startDec 2003
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Model description
- A non-randomized arm was run in parallel with a randomized sub-study consisting of 2 arms; Immediate Treatment and Deferred Treatment. Upon completion of the 6 month observation period, the Deferred Treatment group then crosses over upon implantation to become part of the overall study group.
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- VisDura, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Schanzlin, M.D., Principal investigator, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166568
- Sponsor's protocol ID
- P-277-5
- Status last verified
- Aug 2018
- First submitted
- 16 Jul 2010
- Last updated
- 28 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Trial Of the PresVIEW Scleral Implant (PSI) For the Improvement Of Near Visual Acuity In Presbyopic Patients
- ClinicalTrials.gov ID
- NCT01166568
- Acronym / sponsor ID
- P-277-5
- Conditions
- Presbyopia
- Keywords
- Presbyopia, Reading Vision, Near Vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- VisDura, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Jul 2010 (estimated)
- Results
- Posted 28 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and effectiveness of the PresVIEW™ Scleral Implant (PSI) for the improvement of near visual acuity in presbyopic patients.
Detailed description
The clinical investigation of the PresView™ Scleral Implant (PSI) is a prospective multicenter clinical trial in which a total of 330 subjects were enrolled and implanted with the PSI and followed for a period of 24 months at up to 14 clinical sites.
An additional randomized sub-study was performed on 48 subjects with the PSI Second Generation PresView™(SGP) implant, model number SGP-046. A 2:1 randomization was used to determine the 32 subjects assigned to be implanted and the 16 subjects assigned to the observation/deferred implantation control arm. Subjects randomized to the deferred implantation control arm were eligible to receive the PSI after completion of the 6 months of observation in the study.
All subjects interested in participating in the study were screened for eligibility, and informed consent was obtained from those who meet the inclusion/exclusion criteria. Eligible subjects were examined preoperatively to obtain a medical history and baseline ocular data.
Effectiveness: The following tests/measurements used to evaluate the effectiveness of the PSI procedure will be included in the study protocol:
- Near visual acuity of the operated eye/eyes as compared with baseline (uncorrected and distance corrected)
- Reading acuity of the operated eye/eyes as compared with baseline (uncorrected and distance corrected)
The PSI procedure will be defined as successful if a logMar equivalent to Snellen 20/40 or better (logMar 0.3) is achieved in ≥ 75% of patients or if 75% of patients realize an improvement ≥ 2 lines in distance corrected near visual acuity (DCNVA). For most patients, this will translate into the ability to read the majority of newspaper and magazine print without a near optical aid.
Safety: Primary safety outcomes for safety will include:
- Incidence of anterior segment ischemia
- Decrease in Best Corrected Distance Visual Acuity (BCDVA) of more than 2 lines from baseline at 1-month or more postoperatively
- Decrease in best distance corrected near acuity (with add) of more than 2 lines from baseline at 1-month or more postoperatively
- Intraocular Pressure (IOP) increase > 10mm Hg over baseline or IOP > 25mm Hg after 1 Day postoperative
- Signs of chronic inflammation (e.g. uveitis or chronic conjunctival hyperemia) at 2 months or more postoperatively
- Increase in axial length of ≥ 0.20mm accompanied by a > 0.5 diopter myopic shift in manifest spherical equivalent distance refraction.
- Incidence of adverse events: total not to exceed 5%, and the incidence of each event should not exceed 1-2%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A non-randomized arm was run in parallel with a randomized sub-study consisting of 2 arms; Immediate Treatment and Deferred Treatment. Upon completion of the 6 month observation period, the Deferred Treatment group then crosses over upon implantation to become part of the overall study group.
| Arm | Type | Receives |
|---|---|---|
| Implantation-Non Randomized | Experimental | Device: PresVIEW Scleral ImplantsSubjects are not participants in the randomized sub-study. PresView Scleral Implants surgical placed in the eye(s) after enrollment and meeting inclusion/exclusion criteria. |
| Implantation-Randomized | Experimental | Device: PresVIEW Scleral ImplantsSubjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. PresView Scleral Implants surgical placed in the eye(s)Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. |
| Deferred Implantation-Randomized | No intervention | –Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have PresView Scleral Implants surgically placed in the eye(s) and become part of the overall study experimental group. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject must be between 50-60 years old
- Subject must have a best corrected distance visual acuity of 20/20 or better
- Subject must have SLOAN distance corrected near visual acuity @ 40cm in the operative eye/eyes of 20/50 to 20/100 (inclusive).
- Subject should have a manifest distance spherical equivalent refractive correction in the operative eye/eyes of from -0.50 to +0.75 diopters with no more than 1.00 diopter of astigmatism and should require at least a +1.50 diopter add. The distance manifest refraction spherical equivalent and the distance cycloplegic refraction spherical equivalent must be within 0.50 diopters of each other.
- Subject must be phakic in the study eye
Key exclusion criteria (8 listed)
- Chronic uveitis or other recurrent anterior or posterior segment inflammation in either eye.
- Scleral thickness less than 530 μm in the operative eye/eyes.
- Any previous eye surgeries including cataract, LASIK, or Muscle surgery
- Any history of prior extraocular muscle surgery, specifically the recti or oblique muscles.
- Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.
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 Scleral ImplantsSubjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months. | Device | Implantation-Non Randomized, Implantation-Randomized |
Primary outcome
Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines
Time frame: From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.
Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better or improvement of 2 or more lines at 24 months for the primary eye.
1 secondary outcome
Presence of Significant Safety Events (SAEs).
Time frame: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- US Food and Drug Administration WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
David Schanzlin, M.D. principal investigator
Chief Medical Officer
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PresVIEW Scleral Implants in people with Presbyopia, run by VisDura, Inc. at 14 sites in United States.
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 7 inclusion and 8 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 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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?
Yes. Results are posted in the registry (first posted 28 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines (time frame: From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.). 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 28 Sep 2018.