A clinical trial to monitor the 24 hour intraocular pressure (IOP) with the help of a device named SENSIMED Triggerfish® in patients having primary angle closure and primary angle closure glaucoma before and after laser treatment (peripheral iridotomy)
- Conditions
- Health Condition 1: H400- Glaucoma suspect
- Registration Number
- CTRI/2012/10/003067
- Lead Sponsor
- SENSIMED AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method â?¢Safety endpoint: Adverse events and serious adverse events will be collected throughout the duration of the study <br/ ><br>Timepoint: During all visits (Visit 1 to Visit 6) <br/ ><br>;â?¢To assess the comfort of CLS wear in both groups before and after LPI by use of a visual analog scale (VAS) <br/ ><br>Timepoint: Before and after LPI <br/ ><br>;â?¢To assess the following endpoints before and after LPI: <br/ ><br>oDiurnal and nocturnal IOP pattern <br/ ><br>oThe wake/sleep and sleep/wake slopes <br/ ><br>oTiming of the nycthemeral IOP acrophase <br/ ><br>Timepoint: Visit 5 & Visit 6 <br/ ><br>;â?¢To assess the following endpoints specific to PAC and PACG <br/ ><br>oDiurnal and nocturnal IOP pattern <br/ ><br>oThe wake/sleep and sleep/wake slopes <br/ ><br>oTiming of the nycthemeral IOP acrophase <br/ ><br>Timepoint: Visit1, Visit 2 & Visit 4