Telescope Exchange Study

NCT03011554 | Unknown FDA Device

• 1 other identifier: IMT-TES-2016
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 14

Brief 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

Outcome Measures

Primary Outcomes (1)

• Adverse events

  All reported adverse events will be summarized by number and percent of occurence.

  Subjects will be followed up for three years post implantation

Secondary Outcomes (2)

• Decrease in best corrected distance visual acuity (BCDVA)

  Subjects will be followed up for three years post implantation

• Endothelial Cell Density

  Subjects will be followed up for three years post implantation

Other Outcomes (1)

• Increase in best corrected distance visual acuity (BCDVA)

  Subjects will be followed up for three years post implantation

Study Arms (1)

Implantable Miniature Telescope (IMT)

EXPERIMENTAL

Intervention: Implanting the Implantable Miniature Telescope (IMT) in pseudophakic eyes of patients suffering from binocular end-stage AMD.

Device: Implantable Miniature Telescope (IMT)

Interventions

Implantable Miniature Telescope (IMT) DEVICE

Monocular implantation of the IMT.

Implantable Miniature Telescope (IMT)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Central anterior chamber depth (ACD) \< 3.0 mm; measurement of the ACD should be taken from the posterior surface of the cornea (endothelium) to the anterior surface of the IOL.
• Axial length \< 21 mm or \>27 mm
• Endothelial cell density (ECD) lower than 2300 cells/mm2 for subjects between the ages 65-69, lower than 2000 cells/mm2 for subjects between the ages of 70-74, and lower than 1800 cells/mm2 for subjects 75 years old or greater.
• Corneal stromal or endothelial dystrophies, including guttata
• History of intraocular or corneal surgery (including DSEK) except cataract removal and IOL placement

Sponsors & Collaborators

• VisionCare, Inc.: lead

Study Sites (14)

Retinal Consultants of AZ

Phoenix, Arizona, 85014, United States

RECRUITING

UC Irvine, Gavin Herbert Eye Institute

Irvine, California, 92697, United States

RECRUITING

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

RECRUITING

Eye Physicians of Long Beach

Long Beach, California, 90808, United States

RECRUITING

Eye Care of San Diego

San Diego, California, 92103, United States

RECRUITING

Orange County Retina

Santa Ana, California, 92705, United States

RECRUITING

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

RECRUITING

University of Michigan, Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

RECRUITING

Minnesota Eye Consultants

Minnetonka, Minnesota, 55305, United States

RECRUITING

Associated Eye Care

Stillwater, Minnesota, 55082, United States

RECRUITING

St. John's Clinic - Eye Specialists. Mercy

Springfield, Missouri, 65804, United States

RECRUITING

Eye Associates of New Mexico Vision Research Center

Albuquerque, New Mexico, 87109, United States

RECRUITING

Eye Specialty Group

Memphis, Tennessee, 38120, United States

RECRUITING

Cornea Consultants of Texas

Fort Worth, Texas, 76107, United States

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Sumit Garg, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Derek Kunimoto, MD

  Retinal Consultants of AZ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carole Schreier

CONTACT

(408) 329-9134; carole@visioncareinc.net

Diane Gordon

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 5, 2017
• Study Start: March 22, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2022
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

US (14)