Evaluation of Pascal Laser Trabeculoplaty (PLT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Santa Clara Valley Health & Hospital System.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Optimedica, inc.
Information provided by:
Santa Clara Valley Health & Hospital System
ClinicalTrials.gov Identifier:
NCT00838721
First received: February 5, 2009
Last updated: September 28, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention
Open Angle Glaucoma
Ocular Hypertension
Other: laser trabeculoplasty

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of the Efficacy of Pascal Trabeculoplasty: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Santa Clara Valley Health & Hospital System:

Primary Outcome Measures:
  • intraocular pressure [ Time Frame: 1 week, 1 month, 3 months, 6 months, 9 months and 1 year after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: laser trabeculoplasty
    Deliver laser energy to the trabecular meshwork using the Pascal Laser System
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838721

Contacts
Contact: Christopher J Engelman, MD 408-885-6877 engelman@stanford.edu
Contact: Mona Littman 408-885-6770

Locations
United States, California
Santa Clara Valley Medical Center Recruiting
San Jose, California, United States, 95128
Contact: Kevin Hutchcroft    408-885-3856    kevin.hutchcroft@hhs.sccgov.org   
Sponsors and Collaborators
Santa Clara Valley Health & Hospital System
Optimedica, inc.
Investigators
Principal Investigator: Christopher J Engelman, MD Santa Clara Valley Medical Center
  More Information

No publications provided

Responsible Party: Christopher Engelman, MD, santa Clara Valley Medical Center
ClinicalTrials.gov Identifier: NCT00838721     History of Changes
Other Study ID Numbers: PASCAL-1
Study First Received: February 5, 2009
Last Updated: September 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Santa Clara Valley Health & Hospital System:
Open Angle Glaucoma
Ocular Hypertension
Laser Trabeculoplasty

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014