Telescope Exchange Study



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:65 - Any
Updated:4/28/2018
Start Date:March 22, 2017
End Date:December 31, 2022
Contact:Carole Schreier
Email:carole@visioncareinc.net
Phone:(408) 329-9134

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

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.


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
We found this trial at
14
sites
1200 North Tustin Avenue
Santa Ana, California 92705
Principal Investigator: Rajiv Rathod, MD
Phone: 714-972-8432
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Albuquerque, New Mexico 87109
Principal Investigator: Gregory Ogawa, MD
Phone: 505-888-5757
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Ann Arbor, Michigan 48105
Principal Investigator: Shahzad Mian, MD
Phone: 734-647-8397
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Ann Arbor, MI
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3455 Locke Avenue
Fort Worth, Texas 76107
Principal Investigator: Aaleya Korieshi, MD
Phone: 817-529-3100
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850 Health Sciences Road
Irvine, California 92697
Principal Investigator: Sumit (Sam) Garg, MD
Phone: 949-824-8297
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Irvine, CA
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Michael Rauser, MD
Phone: 909-558-2732
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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3325 Palo Verde Avenue
Long Beach, California 90808
Principal Investigator: Carlos E Martinez, MD
Phone: 562-421-2757
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Long Beach, CA
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825 Ridge Lake Boulevard
Memphis, Tennessee 38120
Principal Investigator: Subba Gollamudi, MD
Phone: 901-685-2200
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10709 Wayzata Boulevard
Minnetonka, Minnesota 55305
Principal Investigator: David Hardten, MD
Phone: 952-567-6111
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Phoenix, Arizona
Principal Investigator: Derek Kunimoto, MD
Phone: 602-222-2221
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San Diego, California 92103
Principal Investigator: John Bokosky, MD
Phone: 800-765-2737
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Sarasota, Florida 34239
Principal Investigator: Marc Levy, MD
Phone: 941-921-5335
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1229 East Seminole Street
Springfield, Missouri 65804
Principal Investigator: Shachar Tauber, MD
Phone: 417-820-7493
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Stillwater, Minnesota 55082
Principal Investigator: Stephen S Lane, MD
Phone: 651-275-3077
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