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

NCT01906138 | Completed

• 1 other identifier: TF-1106
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The 24-hour Intraocular pressure pattern as recorded by Triggerfish in patients with Primary Angle Closure and Primary Angle Closure Glaucoma

  24 hours

Secondary Outcomes (3)

• 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

Study Arms (1)

SENSIMED Triggerfish®

OTHER

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

Device: SENSIMED Triggerfish®

Interventions

SENSIMED Triggerfish® DEVICE

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

SENSIMED Triggerfish®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensimed AG: lead

Study Sites (1)

Fortis Memorial Research Institute, Glaucoma facility

Haryāna, Haryana, 122002, India

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Shibal Bhartiya, MD

  Fortis Memorial Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: July 23, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

IN (1)