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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906138
• Other study ID #: TF-1106
• Status: Completed
• Phase: N/A
• First received: July 19, 2013
• Last updated: August 25, 2014
• Start date: July 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• SENSIMED Triggerfish®
All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish

Locations

Country	Name	City	State
India	Fortis Memorial Research Institute, Glaucoma facility	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Sensimed AG

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 24-hour Intraocular pressure pattern as recorded by Triggerfish in patients with Primary Angle Closure and Primary Angle Closure Glaucoma		24 hours	No
Secondary	To assess the nycthemeral Intraocular pressure patterns specific to PAC and PACG		24 hours	No
Secondary	To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern for each group of patients		24 hours	No
Secondary	To assess the comfort of contact lens sensor wear in patients of Indian origin		24 hours	No