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 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
NCT ID:
NCT03789669
Pre Assignment Details:
A total of 200 subjects were enrolled in the study. 45 subjects were consented but not treated in the study. 3 subjects were one-eye treated with ELITA; and 197 subjects were treated bilateral (one eye treated with ELITA, one eye treated with controlled system iFS). 3 unilaterally treated subjects were excluded from the analysis. A score of 4 or 5: study eye was better than the control eye. A score of 3: equal performance. A score of 1 or 2: study eye was worse than the control eye.
Recruitment Details:
This is a paired-eye study design in which for each subject, one eye is treated with ELITA and the fellow eye is treated with iFS. For the primary endpoints, a relative scale of 1-5 was used to compare the performance of the ELITA treated eye vs iFS treated eye. The primary endpoint evaluations require both eyes to be treated; thus, 3 unilaterally treated subjects were excluded from the analysis. There is only one arm for primary endpoint evaluation; and two arms for other analyses.
Type Units Analyzed:
Eyes
Study:
NCT03789669
Study Brief:
Results Section:
NCT03789669