Telescope Exchange Study (TES)

April 25, 2018 updated by: VisionCare, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Recruiting
        • Retinal Consultants of AZ
        • Contact:
        • Principal Investigator:
          • Derek Kunimoto, MD
    • California
      • Irvine, California, United States, 92697
        • Recruiting
        • UC Irvine, Gavin Herbert Eye Institute
        • Contact:
        • Principal Investigator:
          • Sumit (Sam) Garg, MD
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Rauser, MD
      • Long Beach, California, United States, 90808
        • Recruiting
        • Eye Physicians of Long Beach
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlos E Martinez, MD
        • Sub-Investigator:
          • James W Donovan, MD
      • San Diego, California, United States, 92103
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Orange County Retina
        • Contact:
        • Principal Investigator:
          • Rajiv Rathod, MD
    • Florida
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Retina Institute
        • Contact:
        • Principal Investigator:
          • Marc Levy, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • University of Michigan, Kellogg Eye Center
        • Contact:
        • Principal Investigator:
          • Shahzad Mian, MD
    • Minnesota
      • Minnetonka, Minnesota, United States, 55305
        • Recruiting
        • Minnesota Eye Consultants
        • Principal Investigator:
          • David Hardten, MD
        • Contact:
        • Contact:
      • Stillwater, Minnesota, United States, 55082
        • Recruiting
        • Associated Eye Care
        • Contact:
        • Principal Investigator:
          • Stephen S Lane, MD
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • St. John's Clinic - Eye Specialists. Mercy
        • Contact:
        • Principal Investigator:
          • Shachar Tauber, MD
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • Eye Associates of New Mexico Vision Research Center
        • Contact:
          • Gregory Ogawa, Dr.
          • Phone Number: 505-888-5757
        • Contact:
        • Principal Investigator:
          • Gregory Ogawa, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Eye Specialty Group
        • Contact:
        • Principal Investigator:
          • Subba Gollamudi, MD
    • Texas
      • Fort Worth, Texas, United States, 76107
        • Recruiting
        • Cornea Consultants of Texas
        • Contact:
        • Principal Investigator:
          • Aaleya Korieshi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Subjects will be followed up for three years post implantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Subjects will be followed up for three years post implantation
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.
Subjects will be followed up for three years post implantation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Subjects will be followed up for three years post implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VisionCare, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sumit Garg, MD, University of California, Irvine
  • Principal Investigator: Derek Kunimoto, MD, Retinal Consultants of AZ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMT-TES-2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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