Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-25 @ 12:41 PM
NCT ID:
NCT03633695
Pre Assignment Details:
A total of 548 subjects signed the informed consent form, 79 of whom did not meet inclusion/exclusion criteria and were considered screen failures; leaving 469 subjects who were considered provisionally enrolled in the study. A total of 16 subjects were disqualified or discontinued from the study prior to second eye implantation. There were 453 subjects who were successfully bilaterally implanted in the study (reporting group).
Recruitment Details:
Subjects were recruited from 21 investigative sites within the United States from 04 December 2018 to 21 August 2019. The investigative sites were comprised of similar clinic, surgical center, and equipment requirements necessary for the intended use of the IC-8™ IOL.
Type Units Analyzed:
Eyes
Study:
NCT03633695
Study Brief:
Results Section:
NCT03633695