Post-Approval Study of the Implantable Miniature Telescope

AMD Clinical Trial

— PAS-01  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01757132
• Other study ID #: PAS-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 2010
• Est. completion date: December 2028

Study information

• Verified date: November 2018
• Source: VisionCare, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 770
• Est. completion date: December 2028
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AMD

Intervention

Device:
• Implantable Miniature Telescope
Device - Implantable Miniature Telescope

Locations

Country	Name	City	State
United States	University of Michigan, Kellogg Eye Center	Ann Arbor	Michigan
United States	Emory Eye Center	Atlanta	Georgia
United States	Retina-Vitreous Associates	Beverly Hills	California
United States	Arizona Eye Center	Chandler	Arizona
United States	Pepose Vision Institute	Chesterfield	Missouri
United States	Fine, Hoffman & Packer	Eugene	Oregon
United States	Retina Consultants of Orange County	Fullerton	California
United States	Loma Linda University Health Care	Loma Linda	California
United States	Valley Retina Institute	McAllen	Texas
United States	New York Eye & Ear	New York	New York
United States	Specialty Eye Care (Glaucoma Consultants of Colorado)	Parker	Colorado
United States	Retina Speciality Institute	Pensacola	Florida
United States	Barnet, Dulaney, Perkins Eye	Phoenix	Arizona
United States	Retinal Consultants of Arizona, LTD	Phoenix	Arizona
United States	University of California - Davis	Sacramento	California
United States	Sarasota Retinal Institute	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VisionCare, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term safety study of implantable miniature telescope	Number of persistent vision impairing corneal edema adverse events	5 years after implantation