TF for the Prediction of Visual Field Progression

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03047239
Study type	Interventional
Source	Sensimed AG
Contact
Status	Withdrawn
Phase	N/A
Start date	June 1, 2023
Completion date	June 1, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.