Back to resultsIOP Pattern in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After LPI
Primary Purpose
Glaucoma
Status
Withdrawn
Phase
Not Applicable
Locations
France
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 (LPI). PAC is defined by the presence of a partial or complete iridotrabecular contact(ITC) in more than 2 quadrants with either raised intraocular pressure (IOP) (ie. more than 21 mmHg) and/or PAS; however, with normal optic disc and visual field. PACG is defined by the presence of ITC with either raised IOP and/or PAS, and evidence of glaucomatous optic disc and visual field
- No IOP-lowering drug treatment or a 4-week wash-out period prior to Study Day 0
- Aged ≥18 years, of either sex
- Not more than 6 diopters spherical equivalent on the study eye
- Have given written informed consent, prior to any investigational procedures
Exclusion Criteria:
- History of acute angle closure glaucoma on the study eye
- Secondary angle closure glaucoma on the study eye
- History of ocular surgery within the last 3 months on the study eye
- History of ocular laser treatment, including previous LPI on the study eye
- Corneal or conjunctival abnormality precluding contact lens adaptation on the study eye
- Severe dry eye syndrome on the study eye
- 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
Sites / Locations
- CHNO des Quinze-Vingts, 28 rue Charenton
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SENSIMED Triggerfish®
Arm Description
SENSIMED Triggerfish® (TF) is a CE-marked portable device that monitors the 24-hour intraocular pressure (IOP) pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals wirelessly via a periorbital patched adhesive antenna to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization
Outcomes
Primary Outcome Measures
To evaluate the differences between the nycthemeral intraocular pressure patterns recorded with Triggerfish during two 24-hour periods, in patients with Primary angle closure and Primary angle closure glaucoma, before and after laser peripheral iridotomy
Secondary Outcome Measures
To assess the nycthemeral intraocular pressure patterns specific to primary angle closure and primary angle closure glaucoma
To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern in primary angle closure and primary angle closure glaucoma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01906151
Brief Title
IOP Pattern in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After LPI
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
May 2014
Overall Recruitment Status
Withdrawn
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 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
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SENSIMED Triggerfish®
Arm Type
Other
Arm Description
SENSIMED Triggerfish® (TF) is a CE-marked portable device that monitors the 24-hour intraocular pressure (IOP) pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals wirelessly via a periorbital patched adhesive antenna to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization
Intervention Type
Device
Intervention Name(s)
SENSIMED Triggerfish®
Intervention Description
SENSIMED Triggerfish® (TF) is a CE-marked portable device that monitors the 24-hour intraocular pressure (IOP) pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals wirelessly via a periorbital patched adhesive antenna to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization
Primary Outcome Measure Information:
Title
To evaluate the differences between the nycthemeral intraocular pressure patterns recorded with Triggerfish during two 24-hour periods, in patients with Primary angle closure and Primary angle closure glaucoma, before and after laser peripheral iridotomy
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
To assess the nycthemeral intraocular pressure patterns specific to primary angle closure and primary angle closure glaucoma
Time Frame
24 hours
Title
To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern in primary angle closure and primary angle closure glaucoma
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 (LPI). PAC is defined by the presence of a partial or complete iridotrabecular contact(ITC) in more than 2 quadrants with either raised intraocular pressure (IOP) (ie. more than 21 mmHg) and/or PAS; however, with normal optic disc and visual field. PACG is defined by the presence of ITC with either raised IOP and/or PAS, and evidence of glaucomatous optic disc and visual field
No IOP-lowering drug treatment or a 4-week wash-out period prior to Study Day 0
Aged ≥18 years, of either sex
Not more than 6 diopters spherical equivalent on the study eye
Have given written informed consent, prior to any investigational procedures
Exclusion Criteria:
History of acute angle closure glaucoma on the study eye
Secondary angle closure glaucoma on the study eye
History of ocular surgery within the last 3 months on the study eye
History of ocular laser treatment, including previous LPI on the study eye
Corneal or conjunctival abnormality precluding contact lens adaptation on the study eye
Severe dry eye syndrome on the study eye
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Baudouin, MD
Organizational Affiliation
CHNO des Quinze-Vingts, 28 rue Charenton, 75571 Paris Cedex 12, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHNO des Quinze-Vingts, 28 rue Charenton
City
Paris
ZIP/Postal Code
75571
Country
France
12. IPD Sharing Statement
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IOP Pattern in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After LPI
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