IRB Study Number 23-573
Status Recruiting
Location i Building - Cole Eye Institute
Institute Cole Eye Institute
Description
We invite you to take part in a research study if you have been diagnosed with central vision limiting age-related macular degeneration (AMD), which is when there is deterioration in the center of your retina, and a cataract, which is when the lens your eye uses to focus becomes cloudy, warranting removal. The purpose of this study is to evaluate the safety and effectiveness of the investigational Implantable Miniature Telescope (IMT), Model SING, and to see if it is effective in improving your vision affected by AMD after it is implanted in your eye at the time you have cataract surgery.
The SING IMT is designed to improve vision in patients with stable, yet severe central vision loss, due to age-related macular degeneration. The SING IMT device will only be implanted in one of your eyes. The other eye will not undergo any surgical procedure as part of this research study.
Study participants are expected to attend a pre-operative visit before surgery to determine if you qualify to take part in the study. You will also have visual training and assessments with a low vision specialist prior to surgery. The second visit will be for surgery during which you undergo cataract removal surgery and planned implantation of the SING IMT in one eye. After your surgery, you must return for follow-up visits. You will need to complete 5 follow-up visits after surgery as well as up to 10 in-office visits for vision training with a low vision specialist.
Your participation in the research will last about approximately 14 months after surgery.
Inclusion Criteria
Eligible subjects must meet all the following inclusion criteria:
For Both Eyes:
Be at least 65 years of age at the Pre-operative Visit;
Have ETDRS BCDVA 0.9 to 1.6 logMAR (20/160 to 20/800) at the Pre-operative Visit caused by bilateral central scotomas associated with end-stage AMD;
Have bilateral retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by standard of care fluorescein angiography (FA) prior to confirmation of eligibility at conclusion of the Pre-operative Visit;
Have been monitored by an eye care professional over the 6-month (or longer) period immediately prior to the Pre-operative Visit and have demonstrated no evidence of active choroidal neovascularization (CNV) prior to the Pre-operative Visit as demonstrated by the following:
a) lack of need of treatment for CNV over the past 6 months, and
b) lack of active exudative fluid on optical coherence tomography (OCT) over the past 6 months, and
c) lack of Retinal hemorrhage on exam over a 6-month period or longer
- Agree to participate in post-operative visual training
For the Implanted Eye:
Have evidence of visually significant cataract at the Pre-operative Visit;
Agree to undergo pre-operative training and assessment (1 or more sessions) with low vision specialists (optometrist or occupational therapist) in the use of an external telescope model sufficient for patient assessment and patient must achieve at least a 5-letter ETDRS BCDVA improvement (0.1 logMAR) in the final assessment
For the Non-Implanted Eye:
- Have adequate peripheral vision at the Pre-operative Visit to allow navigation
Exclusion Criteria
Eligible subjects must not meet any of the following exclusion criteria:
For Both Eyes:
Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device;
Have any of the following conditions at the Pre-operative Visit:
a. Stargardt macular dystrophy;
b. Diabetic retinopathy;
c. Untreated retinal tears;
d. Retinal vascular disease;
e. Optic nerve disease;
f. History of retinal detachment;
g. Intraocular tumor;
h. Retinitis pigmentosa;
History of steroid-induced rise in intraocular pressure (IOP), uncontrolled glaucoma, or IOP >22 mmHg at the Pre-operative Visit;
Have known allergy to post-operative medications;
History of eye rubbing or an ocular condition that predisposes subject to eye rubbing are contraindicated as it could cause device dislocation and result in the need for explant;
Have had prior or expected ophthalmic surgery within 30 days of the Operative Visit;
Have any circumstance that, based on the Investigator’s judgment, poses a concern for the subject’s safety;
Any systemic disease or clinical evidence of any condition at the Pre-operative Visit which would make the subject in the opinion of the investigator unsuitable for the study;
Concurrent participation or prior participation in any investigative drug or device study within last 30 days prior to Pre-operative Visit
For the Implanted Eye:
Have central anterior chamber depth (ACD) <3.0 mm from the posterior surface of the cornea (endothelium) to the anterior surface of the crystalline lens at the Pre-operative Visit;
Have an Endothelial Cell Density (ECD) below:
a. 2,000 cells per millimeter, if 65-84 years old;
b. 1,800 cells per millimeter, if 85 years old or greater
(based on the lowest value of the three cell counts performed by technician at investigative site at the Pre-operative Visit)
Have a history of corneal stromal or endothelial dystrophies, including guttata;
Have Myopia > 6.0 D or Hyperopia > 4.0 D by Manifest Refraction at the Pre-operative Visit;
Have an Axial Length (AL) < 21 mm at the Pre-operative Visit;
Have a narrow angle defined as < grade 2 on the Schaffer scale at the Pre-operative Visit;
Ongoing Inflammatory ocular disease at the Pre-operative Visit;
Zonular weakness/instability of crystalline lens, or pseudoexfoliation at the Pre-operative Visit;
Have any condition at the Pre-operative Visit which in the judgement of the Investigator indicates that the haptics cannot be placed within the capsular bag during surgery;
Have had previous intraocular or corneal surgery, including any type of surgery for refractive or therapeutic purposes;
