Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT00976235
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2009-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Long-Term Monitoring Study of the IMT-002 Patients
Sponsor:
VisionCare, Inc.
Organization:
Study Overview
Official Title:
Five Year Follow up of IMT-002 Patients; A Long-Term Monitoring Study of IMT-002 Patients
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 5-year study of patients implanted with the Implantable Miniature Telescope (IMT by Dr. Isaac Lipshitz) under Protocol IMT-002. All patients implanted with the telescope prosthesis who enrolled in the IMT-002 trial were asked to participate in this study to monitor long-term safety. Patients will undergo examinations at six-month intervals up to a total of 5 years following implantation.
Detailed Description:
Every 6 months, manifest refraction, visual acuity, intraocular pressure, slit lamp examination, endothelial cell density, device failures, complications and adverse events will be assessed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: