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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: SENSIMED Triggerfish®

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana, India, 122002
    • Fortis Memorial Research Institute, Glaucoma facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SENSIMED Triggerfish®; All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish	Device: SENSIMED Triggerfish®; All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Sensimed AG
• Investigators: Principal Investigator: Shibal Bhartiya, MD, Fortis Memorial Research Institute

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 19, 2013
• First Submitted That Met QC Criteria: July 19, 2013
• First Posted (Estimate): July 23, 2013

Study Record Updates

• Last Update Posted (Estimate): August 26, 2014
• Last Update Submitted That Met QC Criteria: August 25, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: TF-1106