An Open Label Study Assessing the 24-hour Intraocular Pressure Pattern in PAC and PACG Patients, Before and After Laser Peripheral Iridotomy

Sensimed

Status: Completed

Conditions: Glaucoma

Treatments: Device: SENSIMED Triggerfish®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01906138

TF-1106

Details and patient eligibility

About

The purpose of the study is to determine the relationship of the intraocular pressure patterns recorded during 2 sessions using Triggerfish, before and after elective laser peripheral iridotomy in angle closure glaucoma patients.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of primary angle closure (PAC) or primary angle closure glaucoma (PACG) with indication for laser peripheral iridotomy (PAC is defined by the presence of a partial or complete iridotrabecular contact in more than 2 quadrants with either raised intraocular pressure [i.e. more than 21 mmHg] and/or primary adhesion to the trabecular meshwork (peripheral anterior synechiae [PAS]; however, with normal optic disc and visual field. PACG is defined by the presence of iridotrabecular contact with either raised intraocular pressure and/or PAS, and evidence of glaucomatous optic disc and visual field)
• No intraocular pressure-lowering drug treatment or a 4-week wash-out period prior to study day 0 and throughout the study
• Aged ≥18 years, of either sex
• Not more than 6 diopters spherical equivalent on the study eye
• Not more than 2 diopters cylinder equivalent on the study eye
• Have given written informed consent, prior to any investigational procedure

Exclusion criteria

• History of acute angle closure glaucoma
• Secondary angle closure glaucoma
• History of ocular surgery within the last 3 months
• History of ocular laser treatment, including previous laser peripheral iridotomy
• Corneal or conjunctival abnormality precluding contact lens adaptation
• Severe dry eye syndrome
• Patients with allergy to corneal anesthetic
• Patients with contraindications for silicone contact lens wear
• Patients not able to understand the character and individual consequences of the investigation
• Participation in other clinical research within the last 4 weeks

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

SENSIMED Triggerfish®

Other group

Description:

All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish

Treatment:

Device: SENSIMED Triggerfish®