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

NCT ID: NCT01906138

Last Updated: 2014-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-07-31

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.

Conditions

Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

SENSIMED Triggerfish®

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

Group Type: OTHER

SENSIMED Triggerfish®

Intervention Type: DEVICE

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

Interventions

SENSIMED Triggerfish®

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sensimed AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shibal Bhartiya, MD

Role: PRINCIPAL_INVESTIGATOR

Fortis Memorial Research Institute

Locations

Fortis Memorial Research Institute, Glaucoma facility

Haryāna, Haryana, India

Countries

India

Other Identifiers

TF-1106

Identifier Type: -

Identifier Source: org_study_id