Trials / Unknown
UnknownNCT03011554
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- VisionCare, Inc. · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Implantable Miniature Telescope (IMT) | Monocular implantation of the IMT. |
Timeline
- Start date
- 2017-03-22
- Primary completion
- 2019-12-01
- Completion
- 2022-12-31
- First posted
- 2017-01-05
- Last updated
- 2018-04-26
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03011554. Inclusion in this directory is not an endorsement.