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New telescope implant for patients with late-stage age-related macular degeneration

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)

Not applicable Interventional VisionCare, Inc. · NCT05438732

This study is testing a new small telescope implant to see if it can help older patients with severe vision loss from age-related macular degeneration see better after surgery.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment125 (estimated)
Ages65 Years and up
SexAll
SponsorVisionCare, Inc. Industry-sponsored
Locations10 sites (Loma Linda, California and 9 other locations)
Trial IDNCT05438732 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of a smaller incision, new generation implantable miniature telescope (SING-IMT) in patients suffering from moderate to severe central vision loss due to late-stage age-related macular degeneration (AMD). Eligible patients, aged 65 and older, will undergo assessments to determine their potential benefit from the implant before being scheduled for outpatient surgery during routine cataract procedures. Following the implantation, participants will have multiple follow-up visits and rehabilitation sessions with a low vision specialist over approximately 12 months to monitor their progress and recovery.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 65 and older with specific visual acuity levels and retinal findings associated with late-stage AMD.

Not a fit: Patients with active choroidal neovascularization or those who do not meet the visual acuity criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life for patients with severe vision loss due to AMD by enhancing their visual acuity.

How similar studies have performed: Previous studies involving similar implantable devices have shown promising results, indicating potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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

   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:

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

   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.

Where this trial is running

Loma Linda, California and 9 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Age-Related Macular DegenerationGeographic Atrophycataractbest-corrected distance visual acuity
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.