Post-Approval Study of the Implantable Miniature Telescope

Status:	Enrolling by invitation
Healthy:	No
Age Range:	65 - Any
Updated:	11/18/2018
Start Date:	August 2010
End Date:	December 2028

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

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%.

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.

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.,
- 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

We found this trial at

sites

Sarasota Retinal Institute

Sarasota, Florida 34239

from

Sarasota, FL