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Telescope Exchange Study (TES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03011554
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
VisionCare, Inc.

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
Age-related Macular Degeneration Device: Implantable Miniature Telescope (IMT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 22, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Adverse events [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011554


Contacts
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Contact: Carole Schreier (408) 329-9134 carole@visioncareinc.net
Contact: Diane Gordon +972-3-928-4002 diane@visioncareinc.net

Locations
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United States, Arizona
Retinal Consultants of AZ Recruiting
Phoenix, Arizona, United States, 85014
Contact: Ronald Hawkins    602-222-2221 ext 1104    rhawkins@retinalconsultantsaz.com   
Principal Investigator: Derek Kunimoto, MD         
United States, California
UC Irvine, Gavin Herbert Eye Institute Recruiting
Irvine, California, United States, 92697
Contact: 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
Contact: Marcia Easterly    909-558-2732 ext 22732    MEasterly@llu.edu   
Principal Investigator: Michael Rauser, MD         
Eye Physicians of Long Beach Recruiting
Long Beach, California, United States, 90808
Contact: Marisela Silva    562-421-2757    marisela@eplb.com   
Contact: Martha Cazares    (562) 421-2757    marthac@eplb.com   
Principal Investigator: Carlos E Martinez, MD         
Sub-Investigator: James W Donovan, MD         
Eye Care of San Diego Recruiting
San Diego, California, United States, 92103
Contact: Natasha Ozerskiy    800-765-2737 ext 133    Natasha@EyeCareofSanDiego.com   
Contact: Kim Holdsworth       KimH@eyecareofsandiego.com   
Principal Investigator: John Bokosky, MD         
Orange County Retina Recruiting
Santa Ana, California, United States, 92705
Contact: Marinel Casiano    714-972-8432    mcasiano@ocretina.net   
Principal Investigator: Rajiv Rathod, MD         
United States, Florida
Sarasota Retina Institute Recruiting
Sarasota, Florida, United States, 34239
Contact: Peggy Jelemensky    941-921-5335 ext 232    SRQresearch@aol.com   
Principal Investigator: Marc Levy, MD         
United States, Michigan
University of Michigan, Kellogg Eye Center Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Munira Hussain    734-647-8397    hussain@umich.edu   
Principal Investigator: Shahzad Mian, MD         
United States, Minnesota
Minnesota Eye Consultants Recruiting
Minnetonka, Minnesota, United States, 55305
Contact: Tessa Hugo    952-567-6111    Tlhugo@mneye.colm   
Contact: Lindsey Fallenstein    (952) 567-6111    lrfallenstein@mneye.com   
Principal Investigator: David Hardten, MD         
Associated Eye Care Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Trish Johnson    651-275-3077    pjohnson@associatedeyecare.com   
Principal Investigator: Stephen S Lane, MD         
United States, Missouri
St. John's Clinic - Eye Specialists. Mercy Recruiting
Springfield, Missouri, United States, 65804
Contact: Crystal Trythall    417-820-7493    Crystal.trythall@mercy.net   
Principal Investigator: Shachar Tauber, MD         
United States, New Mexico
Eye Associates of New Mexico Vision Research Center Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Gregory Ogawa, Dr.    505-888-5757      
Contact: Tegan VandenBosch    505.348-9393    tvandenbosch@lrri.org   
Principal Investigator: Gregory Ogawa, MD         
United States, Tennessee
Eye Specialty Group Recruiting
Memphis, Tennessee, United States, 38120
Contact: Michael Sanford    901-685-2200 ext 683    MichaelSanford@esg.md   
Principal Investigator: Subba Gollamudi, MD         
United States, Texas
Cornea Consultants of Texas Recruiting
Fort Worth, Texas, United States, 76107
Contact: Monica Clark    817-529-3100 ext 6    mclark@corneaconsultantstx.com   
Principal Investigator: Aaleya Korieshi, MD         
Sponsors and Collaborators
VisionCare, Inc.
Investigators
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Principal Investigator: Sumit Garg, MD University of California, Irvine
Principal Investigator: Derek Kunimoto, MD Retinal Consultants of AZ
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Responsible Party: VisionCare, Inc.
ClinicalTrials.gov Identifier: NCT03011554    
Other Study ID Numbers: IMT-TES-2016
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases