Status:
COMPLETED
Evaluation of Pascal Laser Trabeculoplaty
Lead Sponsor:
Santa Clara Valley Health & Hospital System
Collaborating Sponsors:
OptiMedica Corporation
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Laser Trabeculoplasty has been shown to be effective in lowering intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG). Although initially demonstrated with the Argon laser (A...
Eligibility Criteria
Inclusion
- Otherwise healthy males and females, older than 18 years of age with two (2) sighted eyes
- Have OAG, PXG, or combined mechanism glaucoma - as long as their angles are open
- Have uncontrolled IOP (\>24mmHg); or controlled with Medicine(s)
- If on medical treatment, have undergone a washout period of at least one month prior to Pascal treatment
- Able and willing to comply with the treatment/follow-up schedule and requirements;
- Able to provide written informed consent
Exclusion
- Pregnant, intending to become pregnant during course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
- Have an advanced visual field defect within 10° of fixation
- Have had previous glaucoma surgery, except for peripheral iridotomy
- Have corneal disease obviating the use of corneal applanation for a reliable IOP measurement, or would cause difficulty in viewing the TM by means of gonioscopic lens
- Using systemic steroids
- Participation in a study of another device or drug within 3 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
- Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study
- No concomitant use of IOP lowering medicine (Group 1)
- No co-existing ocular pathology with the exception of Cataract.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00838721
Start Date
March 1 2008
End Date
March 1 2010
Last Update
October 14 2016
Active Locations (1)
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1
Santa Clara Valley Medical Center
San Jose, California, United States, 95128