Clinical trial NCT03011554: Telescope Exchange Study
Official title: A Prospective, Multicenter Clinical Trial of the Implantable Miniature Telescope in Pseudophakic Eyes With Central Vision Impairment Associated With End-Stage Macular Degeneration.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Age-related Macular Degeneration
Lead sponsor: VisionCare, Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-05
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse events
timeFrame: Subjects will be followed up for three years post implantation
Secondary outcomes:
measure: Decrease in best corrected distance visual acuity (BCDVA)
timeFrame: Subjects will be followed up for three years post implantation
measure: Endothelial Cell Density
timeFrame: Subjects will be followed up for three years post implantation
Other outcomes:
measure: Increase in best corrected distance visual acuity (BCDVA)
timeFrame: Subjects will be followed up for three years post implantation
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of AZ
state: Arizona
city: Irvine
country: United States
facility: UC Irvine, Gavin Herbert Eye Institute
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Long Beach
country: United States
facility: Eye Physicians of Long Beach
state: California
city: San Diego
country: United States
facility: Eye Care of San Diego
state: California
city: Santa Ana
country: United States
facility: Orange County Retina
state: California
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan, Kellogg Eye Center
state: Michigan
city: Minnetonka
country: United States
facility: Minnesota Eye Consultants
state: Minnesota
city: Stillwater
country: United States
facility: Associated Eye Care
state: Minnesota
city: Springfield
country: United States
facility: St. John's Clinic - Eye Specialists. Mercy
state: Missouri
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico Vision Research Center
state: New Mexico
city: Memphis
country: United States
facility: Eye Specialty Group
state: Tennessee
city: Fort Worth
country: United States
facility: Cornea Consultants of Texas
state: Texas
Study officials:
affiliation: University of California, Irvine
name: Sumit Garg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retinal Consultants of AZ
name: Derek Kunimoto, MD
role: PRINCIPAL_INVESTIGATOR
References: