Telescope Exchange Study

Age-related Macular Degeneration Clinical Trial

— TES  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03011554
• Other study ID #: IMT-TES-2016
• Status: Recruiting
• Phase: N/A
• First received: January 2, 2017
• Last updated: April 25, 2018
• Start date: March 22, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2018
• Source: VisionCare, Inc.
• Contact: Carole Schreier
• Phone: (408) 329-9134
• Email: carole[@]visioncareinc.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2022
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
United States	Eye Associates of New Mexico Vision Research Center	Albuquerque	New Mexico
United States	University of Michigan, Kellogg Eye Center	Ann Arbor	Michigan
United States	Cornea Consultants of Texas	Fort Worth	Texas
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 Specialty Group	Memphis	Tennessee
United States	Minnesota Eye Consultants	Minnetonka	Minnesota
United States	Retinal Consultants of AZ	Phoenix	Arizona
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	St. John's Clinic - Eye Specialists. Mercy	Springfield	Missouri
United States	Associated Eye Care	Stillwater	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VisionCare, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Increase in best corrected distance visual acuity (BCDVA)	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
Primary	Adverse events	All reported adverse events will be summarized by number and percent of occurence.	Subjects will be followed up for three years post implantation
Secondary	Decrease in best corrected distance visual acuity (BCDVA)	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
Secondary	Endothelial Cell Density	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