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

A Prospective, Open Label Study Assessing the 24-hour Intraocular Pressure Pattern Monitored by SENSIMED Triggerfish® in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After Laser Peripheral Iridotomy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01906138

Enrollment

Registered

2013-07-23

Start date

2013-07-31

Completion date

2014-07-31

Last updated

2014-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Brief summary

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.

Interventions

DEVICESENSIMED Triggerfish®

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The 24-hour Intraocular pressure pattern as recorded by Triggerfish in patients with Primary Angle Closure and Primary Angle Closure Glaucoma	24 hours

Secondary

Measure	Time frame
To assess the nycthemeral Intraocular pressure patterns specific to PAC and PACG	24 hours
To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern for each group of patients	24 hours
To assess the comfort of contact lens sensor wear in patients of Indian origin	24 hours

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026