Recruiting

Observational StudyTelescope Exchange Study

Sponsor:

VisionCare, Inc.

Code:

NCT03011554

Conditions

Age-related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Implantable Miniature Telescope (IMT)

Study Details

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

Study ID

NCT03011554

Start date

Mar 22, 2017

Status verified date

Apr, 2018

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.
Patients must not meet any of the exclusion criteria below.

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.
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
History of complicated cataract surgery
Compromised capsular bag (previous YAG posterior capsulotomy, evidence of tearing)
History of Radial Keratotomy
Inflammatory ocular disease
Pseudoexfoliation or zonular weakness
Diabetic retinopathy
Untreated retinal tears
Retinal vascular disease
Optic nerve disease
A history of retinal detachment
Intraocular tumor
Retinitis pigmentosa
Prior or expected ophthalmic related surgery within 30 days preceding telescope implantation
Any medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation in the study

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Implantable Miniature Telescope (IMT)

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

Interventions

Implantable Miniature Telescope (IMT)

Monocular implantation of the IMT.

Primary outcome measure

Adverse events [ Time Frame: Subjects will be followed up for three years post implantation ]

Central Contacts and Locations

Central contacts

Carole Schreier

(408) 329-9134 carole@visioncareinc.net

Diane Gordon

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

Locations

Retinal Consultants of AZ

Recruiting

Phoenix, Arizona, United States, 85014

Contacts

Ronald Hawkins

602-222-2221 rhawkins@retinalconsultantsaz.com

Principal Investigator:

Derek Kunimoto, MD

UC Irvine, Gavin Herbert Eye Institute

Recruiting

Irvine, California, United States, 92697

Contacts

Rosie Magallon

949-824-8297 rmagallo@uci.edu

Principal Investigator:

Sumit (Sam) Garg, MD

Loma Linda University Medical Center

Recruiting

Loma Linda, California, United States, 92354

Contacts

Marcia Easterly

909-558-2732 MEasterly@llu.edu

Principal Investigator:

Michael Rauser, MD

Eye Physicians of Long Beach

Recruiting

Long Beach, California, United States, 90808

Contacts

Marisela Silva

562-421-2757 marisela@eplb.com

Martha Cazares

(562) 421-2757 marthac@eplb.com

Principal Investigator:

Carlos E Martinez, MD

Eye Care of San Diego

Recruiting

San Diego, California, United States, 92103

Contacts

Natasha Ozerskiy

800-765-2737 Natasha@EyeCareofSanDiego.com

Kim Holdsworth

KimH@eyecareofsandiego.com

Principal Investigator:

John Bokosky, MD

Orange County Retina

Recruiting

Santa Ana, California, United States, 92705

Contacts

Marinel Casiano

714-972-8432 mcasiano@ocretina.net

Principal Investigator:

Rajiv Rathod, MD

Sarasota Retina Institute

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Peggy Jelemensky

941-921-5335 SRQresearch@aol.com

Principal Investigator:

Marc Levy, MD

University of Michigan, Kellogg Eye Center

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Munira Hussain

734-647-8397 hussain@umich.edu

Principal Investigator:

Shahzad Mian, MD

Minnesota Eye Consultants

Recruiting

Minnetonka, Minnesota, United States, 55305

Contacts

Tessa Hugo

952-567-6111 Tlhugo@mneye.colm

Lindsey Fallenstein

(952) 567-6111 lrfallenstein@mneye.com

Principal Investigator:

David Hardten, MD

Associated Eye Care

Recruiting

Stillwater, Minnesota, United States, 55082

Contacts

Trish Johnson

651-275-3077 pjohnson@associatedeyecare.com

Principal Investigator:

Stephen S Lane, MD

St. John's Clinic - Eye Specialists. Mercy

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Crystal Trythall

417-820-7493 Crystal.trythall@mercy.net

Principal Investigator:

Shachar Tauber, MD

Eye Associates of New Mexico Vision Research Center

Recruiting

Albuquerque, New Mexico, United States, 87109

Contacts

Gregory Ogawa, Dr.

505-888-5757

Tegan VandenBosch

505.348-9393 tvandenbosch@lrri.org

Principal Investigator:

Gregory Ogawa, MD

Eye Specialty Group

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Michael Sanford

901-685-2200 MichaelSanford@esg.md

Principal Investigator:

Subba Gollamudi, MD

Cornea Consultants of Texas

Recruiting

Fort Worth, Texas, United States, 76107

Contacts

Monica Clark

817-529-3100 mclark@corneaconsultantstx.com

Principal Investigator:

Aaleya Korieshi, MD

More Information

Sponsor

VisionCare, Inc.

Last update posted

Apr 26, 2018

Last verified

Apr, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VisionCare, Inc. on 2018-04-26.