Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT05438732
Brief 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).
Detailed Description:
Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study, including assessment of their best-corrected distance- and near- visual acuity with and without refraction, and also when using an external telescope simulator (ETS) to determine if they are likely to benefit from receiving the IMT. If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery. Following implantation, patients will return for 5 post-operative follow-up visits over a period of approximately 12 months. Additionally, patients will have up to 12 rehabilitation/training visits with a low vision specialist
Study:
NCT05438732
Study Brief:
Protocol Section:
NCT05438732