Clinical trial NCT01757132: Post-Approval Study of the Implantable Miniature Telescope
Official title: Post-approval Study of VisionCare's Implantable Miniature Telescope (by Dr. Isaac Lipshitz) in Patients With Bilateral Severe to Profound Central Vision Impairment Assoc. With End-stage Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: AMD
Lead sponsor: VisionCare, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-28
Enrollment: 770
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of the PAS-01 study is to assess the safety of the intraocular as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity \>2 lines from pre-surgery baseline level).

The study will test the null hypothesis that the percentage of patients who experience persistent vision-impairing corneal edema is \>17% against the alternative that the percentage is \<17%. The null hypothesis will be rejected if the upper bound of the two-sided 95% confidence integral for the observed percentage is \<17%.

Detailed description: ECD sub-study. At investigative sites participating in the ECD Sub-Group study, corneal endothelial cell density will be measured by non-contact specular microscopy in a subgroup of 150 patients enrolled in the IMT-PAS-01 in the eye schedule for and implanted with the intraocular telescope at study entry, 3 months, 12, months, 24 months, 36 months, 48 months and 60 months.

Eligibility criteria: Inclusion Criteria:

* stable severe (BVDCA of 10/160 or poorer) to profound (BCDVA of 20/800 or better) vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration.
* 65 years of age or older
* retinal findings of geographic atrophy or disciform scar with foveal involvement
* visually significant cataract
* agree to undergo pre- and post-surgery training and assessment
* achieve at least a 5-letter improvement with external telescope
* have adequate peripheral vision in the eye not scheduled for surgery

Exclusion Criteria:

* Stargardt's macular dystrophy
* Anterior chamber depth \< 3.0mm
* Presence of corneal guttate
* Do not meet minimum age and endothelial cell density requirements
* evidence of CNV or treatment of CNV within the past 6 months
* cognitive impairment that would interfere with ability to understand and complete Acceptance of Risk and Informed Decision Agreement or prevent proper training/rehabilitation
* previous intraocular or cornea surgery of any kind in operative eye, including any type of surgery for either refractive or therapeutic purposes or who have prior or expected ophthalmic related surgery within 30 days preceding intraocular telescope surgery
* history of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP \>22 mm Hg while on maximum medication
* known sensitivity to post-operative medications
* history of eye rubbing or an ocular condition that predisposes eye rubbing
* myopia \>6.0 D
* hyperopia \>4.0D
* axial length \<21mm
* narrow angle, i.e., \<Schaffer grade 2
* cornea stromal or endothelian dystrophies, including guttate
* inflammatory ocular disease
* zonular weakness/instability of crystalline lens, or pseudoexfoliation
* diabetic retinopathy
* untreated retinal tears
* retinal vascular disease
* optic nerve disease
* history of retinal detachment
* intraocular tumor
* retinitis pigmentosa

Primary outcomes:
measure: Long term safety study of implantable miniature telescope
timeFrame: 5 years after implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona, LTD
state: Arizona
city: Phoenix
country: United States
facility: Barnet, Dulaney, Perkins Eye
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Health Care
state: California
city: Sacramento
country: United States
facility: University of California - Davis
state: California
city: Parker
country: United States
facility: Specialty Eye Care (Glaucoma Consultants of Colorado)
state: Colorado
city: Pensacola
country: United States
facility: Retina Speciality Institute
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retinal Institute
state: Florida
city: Atlanta
country: United States
facility: Emory Eye Center
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan, Kellogg Eye Center
state: Michigan
city: Chesterfield
country: United States
facility: Pepose Vision Institute
state: Missouri
city: New York
country: United States
facility: New York Eye & Ear
state: New York
city: Eugene
country: United States
facility: Fine, Hoffman & Packer
state: Oregon
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
Study officials:
affiliation: Johns Hopkins University
name: Oliver D Schein, MD
role: PRINCIPAL_INVESTIGATOR
References: