Status:
COMPLETED
An Open Label Study Assessing the 24-hour Intraocular Pressure Pattern in PAC and PACG Patients, Before and After Laser Peripheral Iridotomy
Lead Sponsor:
Sensimed AG
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ang...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01906138
Start Date
July 1 2013
End Date
July 1 2014
Last Update
August 26 2014
Active Locations (1)
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1
Fortis Memorial Research Institute, Glaucoma facility
Haryāna, Haryana, India, 122002