RECRUITING

Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Prospective, Multicenter Clinical Study of the Implantable Miniature Telescope, Model SING in Patients with Central Vision Impairment Associated with End-stage Age-related Macular Degeneration (AMD)

Quick Facts

Study Start:2022-06-16

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05438732

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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 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 8. Have adequate peripheral vision at the Pre-operative Visit to allow navigation	1. 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 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; 20. Have ophthalmic pathology at the Pre-operative Visit that compromises the patient's peripheral vision based on the Investigator's judgment.

Inclusion Criteria

Exclusion Criteria

1. 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
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
8. Have adequate peripheral vision at the Pre-operative Visit to allow navigation

1. 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
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;
20. Have ophthalmic pathology at the Pre-operative Visit that compromises the patient's peripheral vision based on the Investigator's judgment.

Contacts and Locations

Study Contact

Rebecca Kammer, OD, PhD

CONTACT

+1 (714) 728-1575

rkammer@samsaravision.com

Colleen Collier

CONTACT

+1 (609) 213-9420

ccollier@samsaravision.com

Principal Investigator

Rebecca J Kammer, OD, PhD

STUDY_DIRECTOR

Samsara Vision Inc.

Study Locations (Sites)

Loma Linda University

Loma Linda, California, 92354

United States

Eye Physicians of Long Beach

Long Beach, California, 90815

United States

Sarasota Retina Institute

Sarasota, Florida, 34239

United States

Tallman Eye Associates

Lawrence, Massachusetts, 01841

United States

Oakland Ophthalmic Surgery

Birmingham, Michigan, 48009

United States

Vance Thompson Vision

Omaha, Nebraska, 68137

United States

Atlantic Eye Physicians

Eatontown, New Jersey, 07724

United States

Western Carolina Retinal Associates

Asheville, North Carolina, 28803

United States

Cleveland Clinic | Cole Eye Institute

Cleveland, Ohio, 44195

United States

Methodist Eye Associates | Houston Methodist

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: VisionCare, Inc.

Rebecca J Kammer, OD, PhD, STUDY_DIRECTOR, Samsara Vision Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-16

Study Completion Date2025-12

Study Record Updates

Study Start Date2022-06-16

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

cataract
best-corrected distance visual acuity

Additional Relevant MeSH Terms

Age-Related Macular Degeneration
Geographic Atrophy