A Long-Term Monitoring Study of the IMT-002 Patients

VisionCare

Status: Completed

Conditions: Macular Degeneration

Treatments: Device: IMT - Implantable Miniature Telescope

Study type: Interventional

Funder types: Industry

Identifiers

NCT00976235

IMT-002-LTM

Details and patient eligibility

About

This is a 5-year study of patients implanted with the Implantable Miniature Telescope (IMT by Dr. Isaac Lipshitz) under Protocol IMT-002. All patients implanted with the telescope prosthesis who enrolled in the IMT-002 trial were asked to participate in this study to monitor long-term safety. Patients will undergo examinations at six-month intervals up to a total of 5 years following implantation.

Full description

Every 6 months, manifest refraction, visual acuity, intraocular pressure, slit lamp examination, endothelial cell density, device failures, complications and adverse events will be assessed.

Enrollment: 129 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have participated in the IMT-002 trial.
• Patients must be able to understand and comply with the requirements of the clinical study, and be able to abide by the requirements and restrictions of the study.
• Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.

Exclusion criteria

• Patients who have not participated in the IMT-002 trial.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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129 participants in 1 patient group

IMT

Experimental group

Treatment:

Device: IMT - Implantable Miniature Telescope