Health Condition 1: H400- Glaucoma suspect
Conditions
Interventions
Intervention1: SENSIMED Triggerfish: SENSIMED Triggerfish® (Triggerfish) is a CE-marked portable device that monitors the 24-hour intraocular pressure (IOP) pattern by a wireless contact lens sensor
Sponsors
SENSIMED AG
Max Neeman International
Eligibility
Inclusion criteria
Inclusion criteria: 1) Diagnosis of primary angle closure (PAC) or primary angle closure glaucoma (PACG) with indication for LPI a. PAC is defined by the presence of a partial or complete iridotrabecular contact (ITC) in more than 2 quadrants with either raised IOP (ie. more than 21 mmHg) and/or primary adhesion to the trabecular meshwork (peripheral anterior synechiae, PAS); however, with normal optic disc and visual field. b. PACG is defined by the presence of ITC with either raised IOP and/or PAS, and evidence of glaucomatous optic disc and visual field. 2) No IOP-lowering drug treatment or a 4-week wash-out period prior to SD0 and throughout the study 3) Aged greater than or equal to 18 years, of either sex 4) Not more than 6 diopters spherical equivalent on the study eye 5) Not more than 2 diopters cylinder equivalent on the study eye 6) Have given written informed consent, prior to any investigational procedure
Exclusion criteria
Exclusion criteria: 1) History of acute angle closure glaucoma 2) Secondary angle closure glaucoma 3) History of penetrating ocular surgery within the last 3 months 4) History of glaucoma surgery, including previous LPI 5) Corneal or conjunctival abnormality precluding contact lens adaptation 6) Severe dry eye syndrome 7) Patients with allergy to corneal anesthetic 8) Patients with contraindications for silicone contact lens wear 9) Patients not able to understand the character and individual consequences of the investigation 10) Participation in other clinical research within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 24-hour IOP pattern as recorded by Triggerfish in patients with PAC and PACGTimepoint: The 24-hour IOP pattern as recorded by Triggerfish in patients with PAC and PACG | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Safety endpoint: Adverse events and serious adverse events will be collected throughout the duration of the study Timepoint: During all visits (Visit 1 to Visit 6) ;â?¢ To assess the comfort of CLS wear in both groups before and after LPI by use of a visual analog scale (VAS) Timepoint: Before and after LPI ;â?¢ To assess the following endpoints before and after LPI: o Diurnal and nocturnal IOP pattern o The wake/sleep and sleep/wake slopes o Timing of the nycthemeral IOP acrophase Timepoint: Visit 5 & Visit 6 ;â?¢ To assess the following endpoints specific to PAC and PACG o Diurnal and nocturnal IOP pattern o The wake/sleep and sleep/wake slopes o Timing of the nycthemeral IOP acrophase Timepoint: Visit1, Visit 2 & Visit 4 | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
Max Neeman International
Outcome results
None listed