Back to resultsAn Open Label Study Assessing the 24-hour Intraocular Pressure Pattern in PAC and PACG Patients, Before and After Laser Peripheral Iridotomy
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
SENSIMED Triggerfish®
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma
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
Sites / Locations
- Fortis Memorial Research Institute, Glaucoma facility
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SENSIMED Triggerfish®
Arm Description
All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish
Outcomes
Primary Outcome Measures
The 24-hour Intraocular pressure pattern as recorded by Triggerfish in patients with Primary Angle Closure and Primary Angle Closure Glaucoma
Secondary Outcome Measures
To assess the nycthemeral Intraocular pressure patterns specific to PAC and PACG
To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern for each group of patients
To assess the comfort of contact lens sensor wear in patients of Indian origin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01906138
Brief Title
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
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sensimed AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SENSIMED Triggerfish®
Arm Type
Other
Arm Description
All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish
Intervention Type
Device
Intervention Name(s)
SENSIMED Triggerfish®
Intervention Description
All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish
Primary Outcome Measure Information:
Title
The 24-hour Intraocular pressure pattern as recorded by Triggerfish in patients with Primary Angle Closure and Primary Angle Closure Glaucoma
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
To assess the nycthemeral Intraocular pressure patterns specific to PAC and PACG
Time Frame
24 hours
Title
To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern for each group of patients
Time Frame
24 hours
Title
To assess the comfort of contact lens sensor wear in patients of Indian origin
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shibal Bhartiya, MD
Organizational Affiliation
Fortis Memorial Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fortis Memorial Research Institute, Glaucoma facility
City
Haryana
ZIP/Postal Code
122002
Country
India
12. IPD Sharing Statement
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An Open Label Study Assessing the 24-hour Intraocular Pressure Pattern in PAC and PACG Patients, Before and After Laser Peripheral Iridotomy
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