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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT01319604
Brief Summary:
The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.
Detailed Description:
60 subjects will be enrolled in total. Enrolled patients will be randomized into one of 8 device groups of 6 subjects each or into the control group containing 12 subjects. Patients in the device arm will receive one session of 3-to 24-hour continuous IOP monitoring with SENSIMED Triggerfish®. SENSIMED Triggerfish® monitoring will begin at 18h ± 2 hours for all patients. SENSIMED Triggerfish® will be installed randomly on right or left eyes. During SENSIMED Triggerfish® monitoring on one eye, GAT and/or Perkins IOP measurements will be taken in the fellow eye every 3 hours. Outside this time they will receive GAT and/or IOP measurements every 3 hours in both eyes until the end of the 24-hours period. Patients in the control group will receive GAT and/or ICare PRO IOP measurements every 3 hours for 24 hours in both eyes.
Study:
NCT01319604
Study Brief:
Protocol Section:
NCT01319604