Telescope Exchange Study

A Prospective, Multicenter Clinical Trial of the Implantable Miniature Telescope in Pseudophakic Eyes With Central Vision Impairment Associated With End-Stage Macular Degeneration.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03011554

Acronym

TES

Enrollment

Registered

2017-01-05

Start date

2017-03-22

Completion date

2022-12-31

Last updated

2018-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration

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.

Interventions

DEVICEImplantable Miniature Telescope (IMT)

Monocular implantation of the IMT.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

Primary ContactCarole Schreier

carole@visioncareinc.net(408) 329-9134

Backup ContactDiane Gordon

diane@visioncareinc.net+972-3-928-4002

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026