Trial record 9 of 357 for:    macular degeneration | Open Studies

Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by VisionCare Ophthalmic Technologies, Inc.
Sponsor:
Information provided by (Responsible Party):
VisionCare Ophthalmic Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01731964
First received: November 14, 2012
Last updated: April 30, 2014
Last verified: April 2014

November 14, 2012
April 30, 2014
November 2012
December 2014   (final data collection date for primary outcome measure)
Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Positional stability assessed by slit lamp examination and anterior segment OCT
Same as current
Complete list of historical versions of study NCT01731964 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
adverse events
Same as current
Not Provided
Not Provided
 
Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
Pilot Study of WA-NG Telescope Prosthesis in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration

This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.

Patients will be screened for eligibility and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible patients will be examined preoperatively to obtain a medical history and to establish a baseline for ocular condition. Baseline measurements will include successful use of an external telescope.

Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as specified in this protocol and will be required to return for 6 to 10 additional visits for vision training with a low vision specialist.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Age Related Macular Degeneration
  • Device: Telescope prosthesis
    Monocular implantation of the telescope prosthesis after cataract extraction
    Other Name: IMT-NG
  • Device: WA-NG Telescope Prothesis
    The WA-NG telescope prosthesis (Figure 1) is the next generation telescopic implantable device which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with severe to profound vision impairment due to bilateral, end-stage age-related macular degeneration. The device is implanted in one of the patient's eyes. In this way, the implanted eye provides central vision and the non-implanted eye can continue to provide peripheral vision.
Experimental: WA- NG Telescope Prothesis
Implantable Miniature Telescope for end stage AMD
Interventions:
  • Device: Telescope prosthesis
  • Device: WA-NG Telescope Prothesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

Bi-lateral, stable, moderate to profound (20/80 to 20/800) central vision impairment due to bilateral scotoma associated with end-stage macular degeneration, defined as retinal finds of bilateral, geographic atrophy or disciform scar with foveal involvment. Phakic in the operative eye. Must achieve a 5 letter improved with external telescope simulator.

Exclusion Criteria:

Evidence of active CNV or any ophthalmic pathology that compromises peripheral vision of fellow eye or predisposes eye rubbing. Previous intraocular of corneal surgery of any kind in operative eye. Retinal disease, optic nerve disease, diabetic retinopathy, retinal tears, or any introcular tumor or medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation.

Both
65 Years and older
No
Israel
 
NCT01731964
WA-NG-001 ASSAF HAROFEH
No
VisionCare Ophthalmic Technologies, Inc.
VisionCare Ophthalmic Technologies, Inc.
Not Provided
Principal Investigator: Isaac Avni, MD Assaf-Harofeh Medical Center
VisionCare Ophthalmic Technologies, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP