NCT03047239

TF for the Prediction of Visual Field Progression

A Prospective Study Investigating the Relationship Between SENSIMED Triggerfish® Ocular Dimensional Profiles and Disease Progression in Patients With Open Angle Glaucoma

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sensimed AG · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Baseline 24-hour SENSIMED Triggerfish (TF) recordings as well as functional and structural vision tests measured prospectively every 3 months over a 2-year period, will be used to model TF's ability to serve as a risk factor for individual progression rates.

Detailed description

Glaucoma subjects will be selected based on scheduled appointments (consecutive selection) and clinic records such as patient databases (convenience selection) and invited to participate in the study. After having signed and dated the informed consent form, they will receive an appointment for a screening visit, during which they will undergo an ophthalmic examination and review of their medical and ophthalmic history as well as prior and current treatments. The eye at higher risk of disease progression will be selected for the study if both eyes are eligible. On study day 0 (SD0), subjects will receive TF for a 24-hour recording of the profile of ocular dimensional changes, starting between 11 am and 3 pm, with simultaneous recording of 24-hour blood pressure (BP). The recordings will be carried out in ambulatory conditions with the subjects pursuing as close to normal daily activities as possible. Subject activities will be captured in a logbook. After completion of the recording, subjects will receive an ophthalmic exam to exclude or adequately address any side effects and provide the logbook to the investigator. At 3-month intervals following the TF recording until 2 years after the TF recording, follow-up visits will be scheduled for assessment of the visual field (VF), the retinal nerve fiber layer (RNFL) thickness by optical coherence tomography (OCT), optic disc photo and intraocular pressure (IOP). 24-hour TF recording (starting at the same time as on SD0) will be performed at 1 and 2 years and, if glaucoma subjects undergo a glaucoma surgery in the follow-up period, an additional 24-hour TF profile will be recorded approximately 3 months after the intervention (again starting at the same time as on SD0).

Conditions

• Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	SENSIMED Triggerfish	Smart contact lens based device indicated to detect the peak patterns of variation in intraocular pressure over a maximum period of 24 hours

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2017-02-08
• Last updated: 2025-05-15