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Telescope Exchange Study

NCT03011554 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2018-04-26

No results posted yet for this study

Summary

VisionCare's Implantable Miniature Telescope (IMT, intraocular telescope or telescope) is indicated for monocular implantation to improve vision in eyes of patients at least 65 years of age with severe to profound vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration (AMD).

Patients with end-stage AMD who have undergone bilateral cataract removal and intraocular lens placement are currently contraindicated for telescope surgery.

These patients have no viable therapy available to improve their vision.

The objective of the TES pilot study is to evaluate the safety and effectiveness of implanting the intraocular telescope for improving vision in patients with bilateral end-stage age- related macular degeneration who are pseudophakic.

Conditions

  • Age-related Macular Degeneration

Interventions

DEVICE

Implantable Miniature Telescope (IMT)

Monocular implantation of the IMT.

Sponsors & Collaborators

  • VisionCare, Inc.

    lead INDUSTRY

Principal Investigators

  • Sumit Garg, MD · University of California, Irvine

  • Derek Kunimoto, MD · Retinal Consultants of AZ

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-22
Primary Completion
2019-12-31
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03011554 on ClinicalTrials.gov