Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2017-03-22
2022-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Implantable Miniature Telescope (IMT)
Intervention: Implanting the Implantable Miniature Telescope (IMT) in pseudophakic eyes of patients suffering from binocular end-stage AMD.
Implantable Miniature Telescope (IMT)
Monocular implantation of the IMT.
Interventions
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Implantable Miniature Telescope (IMT)
Monocular implantation of the IMT.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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VisionCare, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sumit Garg, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine
Derek Kunimoto, MD
Role: PRINCIPAL_INVESTIGATOR
Retinal Consultants of AZ
Locations
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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
St. John's Clinic - Eye Specialists. Mercy
Springfield, Missouri, United States
Eye Associates of New Mexico Vision Research Center
Albuquerque, New Mexico, United States
Eye Specialty Group
Memphis, Tennessee, United States
Cornea Consultants of Texas
Fort Worth, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Gregory Ogawa, Dr.
Role: primary
Other Identifiers
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IMT-TES-2016
Identifier Type: -
Identifier Source: org_study_id
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