TES: Telescope Exchange Study

Sponsor
VisionCare, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03011554
Collaborator
(none)
75
14
1
69.3
5.4
0.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Implantable Miniature Telescope (IMT)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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.
Actual Study Start Date :
Mar 22, 2017
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Implantable Miniature Telescope (IMT)

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

Device: Implantable Miniature Telescope (IMT)
Monocular implantation of the IMT.

Outcome Measures

Primary Outcome Measures

  1. Adverse events [Subjects will be followed up for three years post implantation]

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

Secondary Outcome Measures

  1. Decrease in best corrected distance visual acuity (BCDVA) [Subjects will be followed up for three years post implantation]

    Change in LogMar BCDVA from pre-operative visit will be summarized starting at 1 month post-op.

  2. Endothelial Cell Density [Subjects will be followed up for three years post implantation]

    ECD change and % change from preoperative visit will be summarized at each visit starting at 3 months post-op.

Other Outcome Measures

  1. Increase in best corrected distance visual acuity (BCDVA) [Subjects will be followed up for three years post implantation]

    Change in LogMar BCDVA from pre-operative visit will be summarized starting at 1 month post-op.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Retinal Consultants of AZ Phoenix Arizona United States 85014
2 UC Irvine, Gavin Herbert Eye Institute Irvine California United States 92697
3 Loma Linda University Medical Center Loma Linda California United States 92354
4 Eye Physicians of Long Beach Long Beach California United States 90808
5 Eye Care of San Diego San Diego California United States 92103
6 Orange County Retina Santa Ana California United States 92705
7 Sarasota Retina Institute Sarasota Florida United States 34239
8 University of Michigan, Kellogg Eye Center Ann Arbor Michigan United States 48105
9 Minnesota Eye Consultants Minnetonka Minnesota United States 55305
10 Associated Eye Care Stillwater Minnesota United States 55082
11 St. John's Clinic - Eye Specialists. Mercy Springfield Missouri United States 65804
12 Eye Associates of New Mexico Vision Research Center Albuquerque New Mexico United States 87109
13 Eye Specialty Group Memphis Tennessee United States 38120
14 Cornea Consultants of Texas Fort Worth Texas United States 76107

Sponsors and Collaborators

  • VisionCare, Inc.

Investigators

  • Principal Investigator: Sumit Garg, MD, University of California, Irvine
  • Principal Investigator: Derek Kunimoto, MD, Retinal Consultants of AZ

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VisionCare, Inc.
ClinicalTrials.gov Identifier:
NCT03011554
Other Study ID Numbers:
  • IMT-TES-2016
First Posted:
Jan 5, 2017
Last Update Posted:
Apr 26, 2018
Last Verified:
Apr 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2018