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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT05739656
Brief Summary:
The primary objective of this study is to evaluate rotational stability and functional improvements in visual acuity of the enVista monofocal Toric IOL (MX60ET) following cataract surgery.
Detailed Description:
This is a prospective, multicenter, post-market observational study at approximately 5 sites in the United States. All clinical sites will have Institutional Review Board (IRB) approval prior to recruiting potential subjects. All subjects who meet eligibility criteria will be consecutively offered enrollment into the trial. Approximately up to 100 subjects (100 eyes) will be successfully implanted with an enVista Toric IOL (Model MX60ET) in one or both eyes at up to 5 clinical sites in the United States. For subjects with pre-existing cataracts in both eyes requiring removal and IOL implantation, the eye with the worse BCDVA at the preoperative visit will be designated the study eye. If BCDVA is the same for both eyes, the right eye will be designated the study eye. Postoperatively, all subjects will undergo ophthalmic examinations at regular intervals per the study visit schedule through Form 4 (120-180 days postoperative).
Study:
NCT05739656
Study Brief:
Protocol Section:
NCT05739656