Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD
Purpose
The objective of this study is to determine the safety and effectiveness of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD).
Conditions
- Age-Related Macular Degeneration
- Geographic Atrophy
Eligibility
- Eligible Ages
- Over 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Be at least 65 years of age at the Pre-operative Visit; 2. 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; 3. Have bilateral retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by standard of care fluorescein angiography (FA) prior to the Pre-operative Visit; 4. 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: 1. lack of need of treatment for CNV over the past 6 months, and 2. lack of active exudative fluid on optical coherence tomography (OCT) over the past 6 months, and 3. lack of Retinal hemorrhage on exam over a 6-month period or longer 5. Agree to participate in post-operative visual training For the Implanted Eye: 6. Have evidence of visually significant cataract at the Pre-operative Visit; 7. 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: 8. Have adequate peripheral vision at the Pre-operative Visit to allow navigation
Exclusion Criteria
- Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device; 2. Have any of the following conditions at the Pre-operative Visit: 1. Stargardt macular dystrophy; 2. Diabetic retinopathy; 3. Untreated retinal tears; 4. Retinal vascular disease; 5. Optic nerve disease; 6. History of retinal detachment; 7. Intraocular tumor; 8. Retinitis pigmentosa; 3. History of steroid-induced rise in intraocular pressure (IOP), uncontrolled glaucoma, or IOP >22 mmHg at the Pre-operative Visit; 4. Have known allergy to post-operative medications; 5. History of eye rubbing or an ocular condition that predisposes subject to eye rubbing; 6. Have had prior or expected ophthalmic surgery within 30 days of the Operative Visit; 7. Have any circumstance that, based on the Investigator's judgment, poses a concern for the subject's safety; 8. 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; 9. 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: 10. 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; 11. Have an Endothelial Cell Density (ECD) below: 1. 2,000 cells per millimeter, if 65-84 years old; 2. 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) 12. Have a history of corneal stromal or endothelial dystrophies, including guttata; 13. Have Myopia > 6.0 D or Hyperopia > 4.0 D by Manifest Refraction at the Pre-operative Visit; 14. Have an Axial Length (AL) < 21 mm at the Pre-operative Visit; 15. Have a narrow angle defined as < grade 2 on the Schaffer scale at the Pre-operative Visit; 16. Ongoing Inflammatory ocular disease at the Pre-operative Visit; 17. Zonular weakness/instability of crystalline lens, or pseudoexfoliation at the Pre-operative Visit; 18. 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; 19. Have had previous intraocular or corneal surgery, including any type of surgery for refractive or therapeutic purposes; For the Non-Implanted Eye: 20. Have ophthalmic pathology at the Pre-operative Visit that compromises the patient's peripheral vision based on the Investigator's judgment.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Effectiveness: one-sided asymptotic normal test Safety: one-sided t-test
- Primary Purpose
- Other
- Masking
- None (Open Label)
- Masking Description
- since the IMT has a unique appearance in the eye, it cannot be masked to the Investigator or to the patient
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental SING-IMT Implanted |
the implanted eye will be the study eye which receives the SING-IMT. Implantation will occur during routine cataract surgery using a proprietary delivery system (loading cartridge and injector), via an approximately 6.5mm incision |
|
Recruiting Locations
Loma Linda University
Loma Linda, California 92354
Loma Linda, California 92354
Eye Physicians of Long Beach
Long Beach, California 90815
Long Beach, California 90815
Sarasota Retina Institute
Sarasota, Florida 34239
Sarasota, Florida 34239
Tallman Eye Associates
Lawrence, Massachusetts 01841
Lawrence, Massachusetts 01841
Oakland Ophthalmic Surgery
Birmingham, Michigan 48009
Birmingham, Michigan 48009
Vance Thompson Vision
Omaha, Nebraska 68137
Omaha, Nebraska 68137
Atlantic Eye Physicians
Eatontown, New Jersey 07724
Eatontown, New Jersey 07724
Western Carolina Retinal Associates
Asheville, North Carolina 28803
Asheville, North Carolina 28803
Cleveland Clinic | Cole Eye Institute
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Methodist Eye Associates | Houston Methodist
Houston, Texas 77030
Houston, Texas 77030
More Details
- NCT ID
- NCT05438732
- Status
- Recruiting
- Sponsor
- VisionCare, Inc.
Detailed Description
Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study, including assessment of their best-corrected distance- and near- visual acuity with and without refraction, and also when using an external telescope simulator (ETS) to determine if they are likely to benefit from receiving the IMT. If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery. Following implantation, patients will return for 5 post-operative follow-up visits over a period of approximately 12 months. Additionally, patients will have up to 12 rehabilitation/training visits with a low vision specialist