Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD
NCT ID: NCT05438732
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
125 participants
INTERVENTIONAL
2022-06-16
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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
smaller incision, new generation implantable miniature telescope (SING-IMT)
The IMT (model SING) is an intraocular implant comprised of 2 micro lenses in a glass tube (optics) in a flexible silicone carrier (haptics)
Interventions
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smaller incision, new generation implantable miniature telescope (SING-IMT)
The IMT (model SING) is an intraocular implant comprised of 2 micro lenses in a glass tube (optics) in a flexible silicone carrier (haptics)
Eligibility Criteria
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Inclusion Criteria
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
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.
65 Years
ALL
No
Sponsors
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ORA, Inc.
INDUSTRY
VisionCare, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rebecca J Kammer, OD, PhD
Role: STUDY_DIRECTOR
Samsara Vision Inc.
Locations
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Loma Linda University
Loma Linda, California, United States
Eye Physicians of Long Beach
Long Beach, California, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Tallman Eye Associates
Lawrence, Massachusetts, United States
Oakland Ophthalmic Surgery
Birmingham, Michigan, United States
Vance Thompson Vision
Omaha, Nebraska, United States
Atlantic Eye Physicians
Eatontown, New Jersey, United States
Western Carolina Retinal Associates
Asheville, North Carolina, United States
Cleveland Clinic | Cole Eye Institute
Cleveland, Ohio, United States
Methodist Eye Associates | Houston Methodist
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Michael Rauser, MD
Role: backup
Carlos Martinez, MD
Role: backup
Marc Levy, MD
Role: backup
Justine St. Croix, VP of Operations
Role: backup
Tomasz Stryjewski, MD
Role: backup
Timothy Page, MD
Role: backup
Tiffany Facile, MBA, MHA, BS, RN, Research Director
Role: backup
Brandon Baartman, MD
Role: backup
Ravi Patel, MD
Role: backup
W. Zachery Bridges, Jr., MD
Role: backup
Aleksandra Rachitskaya, MD
Role: backup
Jennifer Garrett, BSN, CCRP, Clinical Trials Manager
Role: backup
Rahul Pandit, MD
Role: backup
Other Identifiers
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CDV-SNG-21-001
Identifier Type: -
Identifier Source: org_study_id