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

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Device: SENSIMED Triggerfish®

• Registration Number: NCT01906138
• Lead Sponsor: Sensimed AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-19
• Study First Posted: 2013-07-23
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-25
• Last Update Posted: 2014-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SENSIMED Triggerfish®	SENSIMED Triggerfish®	All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fortis Memorial Research Institute, Glaucoma facility; 🇮🇳 Haryana, India