A prospective, open label study assessing the 24-hour intraocular pressure pattern monitored by SENSIMED TriggerfishÂ® in primary angle closure and primary angle closure glaucoma patients, before and after laser peripheral iridotomy

SENSIMED AG0 个研究点目标入组 30 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

•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

发起方

SENSIMED AG