AMDPAS-01NCT01757132
Post-Approval Study of the Implantable Miniature Telescope
A study testing Implantable Miniature Telescope in people with AMD, run by VisionCare, Inc. at 16 sites in United States.
Trial summary
The objective of the PAS-01 study is to assess the safety of the intraocular as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity >2 lines from… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- AMD
- What is being tested?
- Implantable Miniature Telescope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 770 participants
- Where
- 16 sitesUnited States
- Study dates
- Aug 2010to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- stable severe (BVDCA of 10/160 or poorer) to profound (BCDVA of 20/800 or better) vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration.
- 65 years of age or older
- retinal findings of geographic atrophy or disciform scar with foveal involvement
- visually significant cataract
- agree to undergo pre- and post-surgery training and assessment
- achieve at least a 5-letter improvement with external telescope
- have adequate peripheral vision in the eye not scheduled for surgery
Who cannot join
- Stargardt's macular dystrophy
- Anterior chamber depth < 3.0mm
- Presence of corneal guttate
- Do not meet minimum age and endothelial cell density requirements
- evidence of CNV or treatment of CNV within the past 6 months
- cognitive impairment that would interfere with ability to understand and complete Acceptance of Risk and Informed Decision Agreement or prevent proper training/rehabilitation
Show all 24Show fewer
- previous intraocular or cornea surgery of any kind in operative eye, including any type of surgery for either refractive or therapeutic purposes or who have prior or expected ophthalmic related surgery within 30 days preceding intraocular telescope surgery
- history of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP >22 mm Hg while on maximum medication
- known sensitivity to post-operative medications
- history of eye rubbing or an ocular condition that predisposes eye rubbing
- myopia >6.0 D
- hyperopia >4.0D
- axial length <21mm
- narrow angle, i.e., <Schaffer grade 2
- cornea stromal or endothelian dystrophies, including guttate
- inflammatory ocular disease
- zonular weakness/instability of crystalline lens, or pseudoexfoliation
- diabetic retinopathy
- untreated retinal tears
- retinal vascular disease
- optic nerve disease
- history of retinal detachment
- intraocular tumor
- retinitis pigmentosa
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, 48105
Emory Eye Center
Atlanta, Georgia, 30322
Retina-Vitreous Associates
Beverly Hills, California, 90211
Arizona Eye Center
Chandler, Arizona, 85225
Pepose Vision Institute
Chesterfield, Missouri, 63017
Fine, Hoffman & Packer
Eugene, Oregon, 97401
Retina Consultants of Orange County
Fullerton, California, 92835
Loma Linda University Health Care
Loma Linda, California, 92350
Valley Retina Institute
McAllen, Texas, 78503
New York Eye & Ear
New York, New York, 10003
Specialty Eye Care (Glaucoma Consultants of Colorado)
Parker, Colorado, 80134
Retina Speciality Institute
Pensacola, Florida, 32503
Retinal Consultants of Arizona, LTD
Phoenix, Arizona, 85014
Barnet, Dulaney, Perkins Eye
Phoenix, Arizona, 85016
University of California - Davis
Sacramento, California, 95817
Sarasota Retinal Institute
Sarasota, Florida, 34239
About this study
Official title: Post-approval Study of VisionCare's Implantable Miniature Telescope (by Dr. Isaac Lipshitz) in Patients With Bilateral Severe to Profound Central Vision Impairment Assoc. With End-stage Age-related Macular Degeneration
The objective of the PAS-01 study is to assess the safety of the intraocular as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity >2 lines from pre-surgery baseline level).
The study will test the null hypothesis that the percentage of patients who experience persistent vision-impairing corneal edema is >17% against the alternative that the percentage is <17%. The null hypothesis will be rejected if the upper bound of the two-sided 95% confidence integral for the observed percentage is <17%.
Read the detailed description
ECD sub-study. At investigative sites participating in the ECD Sub-Group study, corneal endothelial cell density will be measured by non-contact specular microscopy in a subgroup of 150 patients enrolled in the IMT-PAS-01 in the eye schedule for and implanted with the intraocular telescope at study entry, 3 months, 12, months, 24 months, 36 months, 48 months and 60 months.
- Conditions
- AMD
- Being tested
- Implantable Miniature Telescope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Miniature TelescopeDevice
Device - Implantable Miniature Telescope
| Study group | Role | What they receive |
|---|---|---|
| Implantable Miniature Telescope | Other | Post approval study Receives: Device: Implantable Miniature Telescope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term safety study of implantable miniature telescope
Number of persistent vision impairing corneal edema adverse events
Measured: 5 years after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startAug 2010
- Primary completionDec 2023 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMDStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VisionCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver D Schein, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757132
- Sponsor's protocol ID
- PAS-01
- Acronym
- PAS-01
- Status last verified
- Nov 2018
- First submitted
- 13 Nov 2012
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-approval Study of VisionCare's Implantable Miniature Telescope (by Dr. Isaac Lipshitz) in Patients With Bilateral Severe to Profound Central Vision Impairment Assoc. With End-stage Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01757132
- Acronym / sponsor ID
- PAS-01 / PAS-01
- Conditions
- AMD
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- VisionCare, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Dec 2012 (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 objective of the PAS-01 study is to assess the safety of the intraocular as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity >2 lines from pre-surgery baseline level).
The study will test the null hypothesis that the percentage of patients who experience persistent vision-impairing corneal edema is >17% against the alternative that the percentage is <17%. The null hypothesis will be rejected if the upper bound of the two-sided 95% confidence integral for the observed percentage is <17%.
Detailed description
ECD sub-study. At investigative sites participating in the ECD Sub-Group study, corneal endothelial cell density will be measured by non-contact specular microscopy in a subgroup of 150 patients enrolled in the IMT-PAS-01 in the eye schedule for and implanted with the intraocular telescope at study entry, 3 months, 12, months, 24 months, 36 months, 48 months and 60 months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantable Miniature Telescope | Other | Device: Implantable Miniature TelescopePost approval study |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- stable severe (BVDCA of 10/160 or poorer) to profound (BCDVA of 20/800 or better) vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration.
- 65 years of age or older
- retinal findings of geographic atrophy or disciform scar with foveal involvement
- visually significant cataract
- agree to undergo pre- and post-surgery training and assessment
Key exclusion criteria (24 listed)
- Stargardt's macular dystrophy
- Anterior chamber depth < 3.0mm
- Presence of corneal guttate
- Do not meet minimum age and endothelial cell density requirements
- evidence of CNV or treatment of CNV within the past 6 months
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 |
|---|---|---|
| Implantable Miniature TelescopeDevice - Implantable Miniature Telescope | Device | Implantable Miniature Telescope |
Primary outcome
Long term safety study of implantable miniature telescope
Time frame: 5 years after implantation
Number of persistent vision impairing corneal edema adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
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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.
Oliver D Schein, MD principal investigator
Johns Hopkins University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Miniature Telescope in people with AMD, run by VisionCare, Inc. at 16 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 24 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: enrolling by invitation, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
This study is still under way. Results are not available in the source record yet.
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?
Long term safety study of implantable miniature telescope (time frame: 5 years after implantation). 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 16 Nov 2018.