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Telescope Exchange Study | Clinical Trials | Clareo Health

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Telescope Exchange Study

A Prospective, Multicenter Clinical Trial of the Implantable Miniature Telescope in Pseudophakic Eyes With Central Vision Impairment Associated With End-Stage Macular Degeneration.

NCT03011554•VisionCare, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by FA
•Be age 65 or older
•Have BCDVA between 20/160 to 20/800 (inclusive) on ETDRS chart
•Be pseudophakic in the eye selected for telescope implantation
•Agree to undergo pre-surgery training with a low vision specialist
•Achieve at least a 5-letter improvement on the ETDRS chart with an external telescope
•Agree to participate in postoperative vision training with a low vision specialist.
•Patients must be able to provide and sign a voluntary informed consent.

Exclusion Criteria

•Stargardt's macular dystrophy
•Cognitive impairment that would interfere with the ability to understand instructions, follow directions, or prevent proper visual training/rehabilitation with the device.
•Any ophthalmic pathology that compromises fellow-eye peripheral vision
•A history of steroid-responsive rise in intraocular pressure (IOP), uncontrolled glaucoma, or preoperative IOP \>22mmHg while on maximum medication
•Known sensitivity to planned study concomitant medications.
•An ocular condition that predisposes the patient to eye rubbing.
•Patients participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
•Operative eye with:
•* Evidence of active CNV or treatment of CNV within 6 months
•* IOLs of the following types: PMMA, Crystalens, Tetraflex, Synchrony.
+19 more criteria

Locations (14)

Retinal Consultants of AZ

Phoenix, Arizona, United States

UC Irvine, Gavin Herbert Eye Institute

Irvine, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Eye Physicians of Long Beach

Long Beach, California, United States

Eye Care of San Diego

San Diego, California, United States

Orange County Retina

Santa Ana, California, United States

Sarasota Retina Institute

Sarasota, Florida, United States

University of Michigan, Kellogg Eye Center

Ann Arbor, Michigan, United States

Minnesota Eye Consultants

Minnetonka, Minnesota, United States

Associated Eye Care

Stillwater, Minnesota, United States

Key Dates

Start Date

March 22, 2017

Primary Completion Date

December 1, 2019

Completion Date

December 31, 2022

Last Updated

April 26, 2018

Enrollment

ESTIMATED participants

Conditions

Age-related Macular Degeneration

Interventions

Implantable Miniature Telescope (IMT)

DEVICE

Contacts

Carole Schreier

CONTACT

(408) 329-9134 carole@visioncareinc.net

Diane Gordon

CONTACT

+972-3-928-4002 diane@visioncareinc.net

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 26, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Telescope Exchange Study

Inclusion Criteria

Exclusion Criteria

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