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Evaluation of Pascal Laser Trabeculoplaty (PLT)

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
laser trabeculoplasty
Sponsored by
Santa Clara Valley Health & Hospital System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Open Angle Glaucoma, Ocular Hypertension, Laser Trabeculoplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Santa Clara Valley Medical Center

Outcomes

Primary Outcome Measures

intraocular pressure

Secondary Outcome Measures

Full Information

First Posted
February 5, 2009
Last Updated
October 12, 2016
Sponsor
Santa Clara Valley Health & Hospital System
Collaborators
OptiMedica Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00838721
Brief Title
Evaluation of Pascal Laser Trabeculoplaty
Acronym
PLT
Official Title
Prospective Evaluation of the Efficacy of Pascal Trabeculoplasty: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santa Clara Valley Health & Hospital System
Collaborators
OptiMedica Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension
Keywords
Open Angle Glaucoma, Ocular Hypertension, Laser Trabeculoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
laser trabeculoplasty
Intervention Description
Deliver laser energy to the trabecular meshwork using the Pascal Laser System
Primary Outcome Measure Information:
Title
intraocular pressure
Time Frame
1 week, 1 month, 3 months, 6 months, 9 months and 1 year after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J Engelman, MD
Organizational Affiliation
Santa Clara Valley Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Clara Valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States

12. IPD Sharing Statement

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Evaluation of Pascal Laser Trabeculoplaty

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