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OpenTrials
Completed

NCT Number: NCT00838721

Evaluation of Pascal Laser Trabeculoplaty

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.

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laser trabeculoplasty

Other

Deliver laser energy to the trabecular meshwork using the Pascal Laser System

Primary outcomes

  1. intraocular pressure

    Time frame: 1 week, 1 month, 3 months, 6 months, 9 months and 1 year after treatment

Sponsors and collaborators

Lead sponsor

Santa Clara Valley Health & Hospital System

Other

Collaborators

  • OptiMedica Corporation

Registry information

Official study title

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

Acronym: PLT

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 6, 2009
Registry last updated
Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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