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

NCT05438732 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2024-12-03

No results posted yet for this study

Summary

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

Interventions

DEVICE

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)

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY
  • VisionCare, Inc.

    lead INDUSTRY

Principal Investigators

  • Rebecca J Kammer, OD, PhD · Samsara Vision Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-16
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05438732 on ClinicalTrials.gov