Evaluation of Pascal Laser Trabeculoplaty (PLT)

Prospective Evaluation of the Efficacy of Pascal Trabeculoplasty: A Pilot Study

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 (ALT), several other laser systems have also been employed with comparable efficacy. Recently, Selective Laser Trabeculoplasty (SLT) has been shown to lower intraocular pressure comparable to ALT. The advantage of SLT is that the target eye structure, the trabecular meshwork, remains intact with minimal damage at the cellular level. In contrast, ALT lowers IOP at the expense of scarring of the trabecular meshwork. The purpose of this study is to evaluate the efficacy of lowering IOP with Pascal Laser Trabeculoplasty (PLT) employing reduced energy levels compared to ALT and a computer guided pattern of laser treatment applications.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Other: laser trabeculoplasty

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95128
      • Santa Clara Valley Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Otherwise healthy males and females, older than 18 years of age with two (2) sighted eyes
2. Have OAG, PXG, or combined mechanism glaucoma - as long as their angles are open
3. Have uncontrolled IOP (>24mmHg); or controlled with Medicine(s)
4. If on medical treatment, have undergone a washout period of at least one month prior to Pascal treatment
5. Able and willing to comply with the treatment/follow-up schedule and requirements;
6. Able to provide written informed consent

Exclusion Criteria:

1. Pregnant, intending to become pregnant during course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
2. Have an advanced visual field defect within 10° of fixation
3. Have had previous glaucoma surgery, except for peripheral iridotomy
4. 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
5. Using systemic steroids
6. 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
7. 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
8. No concomitant use of IOP lowering medicine (Group 1)
9. No co-existing ocular pathology with the exception of Cataract.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
intraocular pressure	1 week, 1 month, 3 months, 6 months, 9 months and 1 year after treatment

Collaborators and Investigators

• Sponsor: Santa Clara Valley Health & Hospital System
• Collaborators: OptiMedica Corporation
• Investigators: Principal Investigator: Christopher J Engelman, MD, Santa Clara Valley Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: February 5, 2009
• First Submitted That Met QC Criteria: February 5, 2009
• First Posted (Estimate): February 6, 2009

Study Record Updates

• Last Update Posted (Estimate): October 14, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Ocular Hypertension; Open Angle Glaucoma; Laser Trabeculoplasty
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
• Other Study ID Numbers: PASCAL-1