Telescope Exchange Study

• Implantable Miniature Telescope (IMT) (Device): Monocular implantation of the IMT.

Primary outcomes

• Adverse events [Subjects will be followed up for three years post implantation]: All reported adverse events will be summarized by number and percent of occurence.

Secondary outcomes

• Decrease in best corrected distance visual acuity (BCDVA) [Subjects will be followed up for three years post implantation]: Change in LogMar BCDVA from pre-operative visit will be summarized starting at 1 month post-op.
• Endothelial Cell Density [Subjects will be followed up for three years post implantation]: ECD change and % change from preoperative visit will be summarized at each visit starting at 3 months post-op.

Other outcomes

• Increase in best corrected distance visual acuity (BCDVA) [Subjects will be followed up for three years post implantation]: Change in LogMar BCDVA from pre-operative visit will be summarized starting at 1 month post-op.

Sex: All, ages: 65 Years to any

Inclusion Criteria:

* Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by FA
* Be age 65 or older
* Have BCDVA between 20/160 to 20/800 (inclusive) on ETDRS chart
* Be pseudophakic in the eye selected for telescope implantation
* Agree to undergo pre-surgery training with a low vision specialist
* Achieve at least a 5-letter improvement on the ETDRS chart with an external telescope
* Agree to participate in postoperative vision training with a low vision specialist.
* Patients must be able to provide and sign a voluntary informed consent.
* Patients must not meet any of the exclusion criteria below.

Exclusion Criteria:

* Stargardt's macular dystrophy
* Cognitive impairment that would interfere with the ability to understand instructions, follow directions, or prevent proper visual training/rehabilitation with the device.
* Any ophthalmic pathology that compromises fellow-eye peripheral vision
* A history of steroid-responsive rise in intraocular pressure (IOP), uncontrolled glaucoma, or preoperative IOP >22mmHg while on maximum medication
* Known sensitivity to planned study concomitant medications.
* An ocular condition that predisposes the patient to eye rubbing.
* Patients participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
* Operative eye with:

  * Evidence of active CNV or treatment of CNV within 6 months
  * IOLs of the following types: PMMA, Crystalens, Tetraflex, Synchrony.
  * Central anterior chamber depth (ACD) < 3.0 mm; measurement of the ACD should be taken from the posterior surface of the cornea (endothelium) to the anterior surface of the IOL.
  * Axial length < 21 mm or >27 mm
  * Endothelial cell density (ECD) lower than 2300 cells/mm2 for subjects between the ages 65-69, lower than 2000 cells/mm2 for subjects between the ages of 70-74, and lower than 1800 cells/mm2 for subjects 75 years old or greater.
  * Corneal stromal or endothelial dystrophies, including guttata
  * History of intraocular or corneal surgery (including DSEK) except cataract removal and IOL placement
  * History of complicated cataract surgery
  * Compromised capsular bag (previous YAG posterior capsulotomy, evidence of tearing)
  * History of Radial Keratotomy
  * Inflammatory ocular disease
  * Pseudoexfoliation or zonular weakness
  * Diabetic retinopathy
  * Untreated retinal tears
  * Retinal vascular disease
  * Optic nerve disease
  * A history of retinal detachment
  * Intraocular tumor
  * Retinitis pigmentosa
  * Prior or expected ophthalmic related surgery within 30 days preceding telescope implantation
  * Any medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation in the study

• Sumit Garg, MD, Principal investigator, University of California, Irvine
• Derek Kunimoto, MD, Principal investigator, Retinal Consultants of AZ