PresbyopiaNCT01895088
A Continuation Study To Monitor The Long Term Safety Of Patients Completing Protocols ACU-P08-020/020A
A study testing AcuFocus Corneal Inlay ACI 7000 PDT in people with Presbyopia, run by AcuFocus, Inc. at 13 sites in United States.
Trial summary
This is a 2 year follow up study to monitor the long term safety of the ACI 7000PDT in subjects who are still implanted with the ACI and have successfully completed the ACU-P08-020/020A studies. 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?
- AcuFocus Corneal Inlay ACI 7000 PDT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 13 sitesUnited States
- Study dates
- May 2011to Aug 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 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients must have completed participation in the ACU-P08-020/020A clinical trial.
- Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.
Who cannot join
- Patients who did not complete ACU-P08-020/020A.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Pepose Vision Institute
Chesterfield, Missouri, 63017
Kraff Eye Institute
Chicago, Illinois, 60602
McDonald Eye Associates
Fayetteville, Arkansas, 72703
Eye Center NOCO
Fort Collins, Colorado, 80525
Eye Surgeons of Indiana
Indianapolis, Indiana, 46256
Maloney Vision
Los Angeles, California, 90024
Davis Duehr Dean
Madison, Wisconsin, 53715
NVision
Newport Beach, California, 92660
Durrie Vision
Overland Park, Kansas, 66211
University of Rochester Eye Institute - Strong Vision
Rochester, New York, 14618
Hoopes Vision
Sandy City, Utah, 84070
Vance Thompson Vision
Sioux Falls, South Dakota, 57105
The Cornea & Laser Eye Institute, P.A
Teaneck, New Jersey, 07666
About this study
Official title: A Continuation Study To Monitor The Long Term Safety Of The AcuFocus ™ ACI 7000PDT Patients Completing Protocols ACU-P08-020/020A
This is a 2 year follow up study to monitor the long term safety of the ACI 7000PDT in subjects who are still implanted with the ACI and have successfully completed the ACU-P08-020/020A studies.
Read the detailed description
This is a two year follow up study designed to monitor and obtain long-term safety data of the ACI 7000PDT in subjects who participated and successfully completed the ACU-P08-020/020A studies. Subjects must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form prior to participating. This continuation study follows subjects still implanted with the ACI and includes two visits, at 12-month intervals, after subjects have been exited (at Month 36) from the ACU-P08-020/020A studies. The first visit is at Month 48 following implantation followed by a final Month 60 visit. The study parameters being measured at these two visits include:
- Specular microscopy
- Slit lamp and fundus examination (ocular health)
- Corrected and uncorrected visual acuity
- Manifest mid-point refraction
- Corneal topography
- Dry eye assessment
- Mesopic and Photopic contrast sensitivity
- Adverse events and complications
All sites participating in the ACU-P08-020/020A studies were invited to participate in the continuation study.
- Conditions
- Presbyopia
- Being tested
- AcuFocus Corneal Inlay ACI 7000 PDT
- Keywords
- presbyopia
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcuFocus Corneal Inlay ACI 7000 PDTDevice
Also called AcuFocus KAMRA inlay
Inlay implanted in cornea for improvement of near vision
| Study group | Role | What they receive |
|---|---|---|
| Patients prev. impl. with ACI 7000 PDT | Experimental | AcuFocus Corneal Inlay ACI 7000 PDT Receives: Device: AcuFocus Corneal Inlay ACI 7000 PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (Increase) in Uncorrected Near Visual Acuity
The change in the number of lines of threshold visual acuity achieved postoperatively.
Measured: Baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startMay 2011
- Primary completionApr 2015
- Study completionAug 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- AcuFocus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Durrie, M.D., Principal investigator, Durrie VisionChad Betts, M.D., R.Ph, Principal investigator, MacDonald Eye AssociatesVance Thompson, M.D., Principal investigator, Vance Thompson VisionJay Pepose, M.D., Principal investigator, Pepose Vision InstituteKevin Waltz, M.D., Principal investigator, Eye Surgeons of IndianaJohn Vukich, M.D., Principal investigator, Davis Duehr DeanPeter Hersh, M.D., Principal investigator, Cornea and Laser Eye InstituteThomas Tooma, M.D., Principal investigator, NVision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895088
- Sponsor's protocol ID
- ACU-P12-020C
- Status last verified
- Jul 2017
- First submitted
- 3 May 2013
- Last updated
- 1 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Continuation Study To Monitor The Long Term Safety Of The AcuFocus ™ ACI 7000PDT Patients Completing Protocols ACU-P08-020/020A
- ClinicalTrials.gov ID
- NCT01895088
- Acronym / sponsor ID
- ACU-P12-020C
- Conditions
- Presbyopia
- Keywords
- presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- AcuFocus, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2 year follow up study to monitor the long term safety of the ACI 7000PDT in subjects who are still implanted with the ACI and have successfully completed the ACU-P08-020/020A studies.
Detailed description
This is a two year follow up study designed to monitor and obtain long-term safety data of the ACI 7000PDT in subjects who participated and successfully completed the ACU-P08-020/020A studies. Subjects must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form prior to participating. This continuation study follows subjects still implanted with the ACI and includes two visits, at 12-month intervals, after subjects have been exited (at Month 36) from the ACU-P08-020/020A studies. The first visit is at Month 48 following implantation followed by a final Month 60 visit. The study parameters being measured at these two visits include:
- Specular microscopy
- Slit lamp and fundus examination (ocular health)
- Corrected and uncorrected visual acuity
- Manifest mid-point refraction
- Corneal topography
- Dry eye assessment
- Mesopic and Photopic contrast sensitivity
- Adverse events and complications
All sites participating in the ACU-P08-020/020A studies were invited to participate in the continuation study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients prev. impl. with ACI 7000 PDT | Experimental | Device: AcuFocus Corneal Inlay ACI 7000 PDTAcuFocus Corneal Inlay ACI 7000 PDT |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients must have completed participation in the ACU-P08-020/020A clinical trial.
- Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.
Key exclusion criteria (1 listed)
- Patients who did not complete ACU-P08-020/020A.
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 |
|---|---|---|
| AcuFocus Corneal Inlay ACI 7000 PDTAlso: AcuFocus KAMRA inlayInlay implanted in cornea for improvement of near vision | Device | Patients prev. impl. with ACI 7000 PDT |
Primary outcome
Change (Increase) in Uncorrected Near Visual Acuity
Time frame: Baseline and 2 years
The change in the number of lines of threshold visual acuity achieved postoperatively.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor 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.
Daniel Durrie, M.D. principal investigator
Durrie Vision
Chad Betts, M.D., R.Ph principal investigator
MacDonald Eye Associates
Vance Thompson, M.D. principal investigator
Vance Thompson Vision
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcuFocus Corneal Inlay ACI 7000 PDT in people with Presbyopia, run by AcuFocus, Inc. at 13 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 2 inclusion and 1 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 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 Jun 2017). 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?
Change (Increase) in Uncorrected Near Visual Acuity (time frame: Baseline and 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 1 Aug 2017.