Clinical trial NCT01906138: An Open Label Study Assessing the 24-hour Intraocular Pressure Pattern in PAC and PACG Patients, Before and After Laser Peripheral Iridotomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2013-07-23
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: The 24-hour Intraocular pressure pattern as recorded by Triggerfish in patients with Primary Angle Closure and Primary Angle Closure Glaucoma
timeFrame: 24 hours
Secondary outcomes:
measure: To assess the nycthemeral Intraocular pressure patterns specific to PAC and PACG
timeFrame: 24 hours
measure: To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern for each group of patients
timeFrame: 24 hours
measure: To assess the comfort of contact lens sensor wear in patients of Indian origin
timeFrame: 24 hours
Other outcomes:
Locations:
city: Haryana
country: India
facility: Fortis Memorial Research Institute, Glaucoma facility
Study officials:
affiliation: Fortis Memorial Research Institute
name: Shibal Bhartiya, MD
role: PRINCIPAL_INVESTIGATOR
References: