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|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P050034 / PAS001 |
| Date Original Protocol Accepted |
07/01/2010
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| Date Current Protocol Accepted |
03/22/2019
|
| Study Name |
IMT PAS 01 New Enrollment Study
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| Device Name |
IMPLANTABLE MINIATURE TELESCOPE (IMT)
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
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| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of the study is to assess the safety of the intraocular telescope 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).
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| Study Population |
Patients planned for implantation with an Implantable Miniature Telescope.
Inclusion Criteria:
1. Subject must be greater than or equal to 65 years of age.
2. Subject must have stable BCDVA of 20/160 to 20/800 in the study eye.
3. Subject must have geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography.
4. Subject must have evidence of visually significant cataract (greater than or equal to Grade 2) in the study eye.
5. Subject must undergo pre-surgery training and assessment (typically 2 to 4 sessions) with low vision specialists (optometrist or occupational therapist) in the use of an external telescope sufficient for patient assessment and for the patient to make an informed decision.
6. Subject must achieve at least a 1-line improvement (0.1 LogMAR equivalent) in the eye with the use of an external telescope.
7. Subject must have adequate peripheral vision in the fellow eye.
8. Subject must agree to participate in postoperative visual training with a low vision specialist.
9. Subject must meet the following minimum endothelial cell density requirements:
Exclusion Criteria:
1. Subject with Stargardt’s macular dystrophy in either eye.
2. Central anterior chamber depth (ACD) < 3.0 mm (endothelium to anterior surface of the crystalline lens) in the study eye.
3. Presence of corneal stromal or endothelial dystrophies, including guttata in either eye.
4. Cognitive impairment that would interfere with the ability to understand and complete the Acceptance of Risk and Informed Decision Agreement or prevent proper visual training/rehabilitation with the device.
5. Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or treatment for CNV within the past six months in the study eye.
6. Any ophthalmic pathology that compromises the patient’s peripheral vision in the fellow eye.
7. Previous intraocular or corneal surgery of any kind in the study eye, including any type of surgery for either refractive or therapeutic purposes.
8. History of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP >22 mm Hg, while on maximum medication in study eye.
9. Known sensitivity to post-operative medications in either eye.
10. History of eye rubbing or an ocular condition that predisposes them to eye rubbing.
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| Sample Size |
A total of 257 patients are targeted for enrollment in order to achieve 150 evaluable patients that complete the study and are included in the primary evaluations.
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| Key Study Endpoints |
The primary study endpoint will be the occurrence of persistent vision- impairing corneal edema, measured at the last available visit.
A secondary endpoint will be the rate of ECD loss and the incidence of ocular adverse events associated with use of the intraocular telescope as a marketed product will be evaluated. Events of interest include surgical complications, corneal transplantation, retinal detachment, device explant, and device malfunction.
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| Follow-up Visits and Length of Follow-up |
60 months
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| Interim or Final Data Summary |
| Interim Results |
Serious Adverse Events n (%)
Ocular BCDVA > 2-line loss (persistent)* Conjunctivitis: 3 (8.3)
Corneal ulcer: 1 (2.8)
Iris prolapse: 1 (2.8)
Posterior capsule rupture: 2 (5.6)
Unknown ADE: 1 (2.8)
Vitreous Strand: 1 (2.8)
Wound dehiscence: 1 (2.8)
Zonular dehiscence: 1 (2.8)
Endothelial cell count subjects and numbers are copied over below. Mean ECD in the Evaluable Cohort (see Table 20) prior to surgery was 2,353 cells/mm2. At Months 3, 12, 24, 36, 48 and 60 postoperative, the mean ECD % loss from preoperative baseline is 12.88%, 12.93%, 11.88%, 2.12%, 13.18% and 0.28%, respectively (these percentages were 12.88, 12.93, 10.18, 6.15, 17.74 and 5.80 in previous reporting period).
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| Actual Number of Patients Enrolled |
36
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| Actual Number of Sites Enrolled |
17
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| Patient Follow-up Rate |
37 percent, 10 subjects lost to follow-up, which is 1 more since the last report. Information on minimizing such incidences remain same in that sites are encouraged to engage subjects and motivate them to gather safety data emphasizing benefit to their clinical care (page 38).
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| Final Effect Findings |
Applicant provided (Table 12 page 19) updated BCDVA line change from baseline. Results at 60 months show little change in that 1 subject slightly improved while 2 subjects slightly worsened. Performance comparable to previous reporting period.
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