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|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P050034 / PAS001 |
| Date Original Protocol Accepted |
07/01/2010
|
| Date Current Protocol Accepted |
12/17/2024
|
| Study Name |
IMT PAS 01 New Enrollment Study
|
| Device Name |
IMPLANTABLE MINIATURE TELESCOPE (IMT)
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| 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 [BCDVA] >2 lines from pre-surgery baseline level).
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| Study Population |
Adult: >21
|
| Sample Size |
Number of subjects: 257
Assumptions for sample size estimation: A total of 257 patients planned for implantation with the intraocular telescope will be enrolled, in order to achieve 150 evaluable patients.
Number of sites: 14
Sites location: US
|
| Key Study Endpoints |
Safety Endpoints
Primary: Primary: the occurrence of persistent vision-impairing corneal edema (corneal edema leading to a persistent loss of BCDVA > 2 lines (> 0.2 LogMAR units) from pre-surgery baseline level at the last available visit).
Secondary: Endothelial cell density (ECD) counts and the rate of endothelial cell loss (ECL) in the implanted eye will be evaluated at baseline and postoperative visits.
Effectiveness Endpoints
Primary: N/A
Secondary: N/A
|
| Follow-up Visits and Length of Follow-up |
60 months
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results:
Adverse Events of Interest:
Persistent BCDVA loss > 2 lines from pre-surgery baseline (present at study exit): 4
Inflammatory Deposits or Precipitates on IMT: 9
Device explant: 1
Mean Endothelial Cell Density (ECD) by Visit
Mean ECD in the Evaluable Cohort 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 was 13%, 13%, 12%, 2%, 14% and 0.3%, respectively.
Other adverse events that may be related to the device
Constricted / Distorted pupil: 2
Iris prolapse: 2
Diplopia: 2
Endothelial Pigment Cornea: 2
Corneal Folds (Corneal/Descemet/Endothelium): 4
Posterior capsular opacification: 1
Posterior capsular rupture: 1
Pseudophacodonesis: 1
Zonular dehiscence: 1
Effectiveness Results:
The primary study outcome was the occurrence of persistent vision-impairing corneal edema (corneal edema leading to a persistent loss of BCDVA > 2 lines from pre-surgery baseline level at the last available visit). Loss of BCDVA > 2 lines was:
* 11% subjects at 12 months,
* 8% subjects at 24 months,
* 18% subjects at 48 months, and
* 19% subjects at the final visit (60 months).
|
| Actual Number of Patients Enrolled |
36
|
| Actual Number of Sites Enrolled |
14
|
| Patient Follow-up Rate |
36/36 subjects completed 1 month
34/36 subjects completed 3 months
32/35 subjects completed 6 months
28/33 subjects completed 12 months
24/30 subjects completed 24 months
22/27 subjects completed 36 months
18/19 subjects completed 48 months
16/16 subjects completed 60 months
There were 25 missed visits.
19 subjects have discontinued.
9 subjects have been lost to follow-up.
There is one active subject (has completed 12 month visit).
|
| 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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