NCT00976235

A Long-Term Monitoring Study of the IMT-002 Patients

Five Year Follow up of IMT-002 Patients; A Long-Term Monitoring Study of IMT-002 Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: VisionCare, Inc. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DEVICE	IMT - Implantable Miniature Telescope	Implantation of the telescope prosthesis (performed under the initial study)

Timeline

• Start date: 2006-06-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-09-14
• Last updated: 2017-11-06

Locations

28 sites across 1 country: United States