NCT01757132

Post-Approval Study of the Implantable Miniature Telescope

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 770 (estimated)
• Sponsor: VisionCare, Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• AMD

Interventions

Type	Name	Description
DEVICE	Implantable Miniature Telescope	Device - Implantable Miniature Telescope

Timeline

• Start date: 2010-08-01
• Primary completion: 2023-12-01
• Completion: 2028-12-01
• First posted: 2012-12-28
• Last updated: 2018-11-16

Locations

16 sites across 1 country: United States