Evaluation of Pascal Laser Trabeculoplaty

Ocular Hypertension Clinical Trial

— PLT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838721
• Other study ID #: PASCAL-1
• Status: Completed
• Phase: N/A
• First received: February 5, 2009
• Last updated: October 12, 2016
• Start date: March 2008
• Est. completion date: March 2010

Study information

• Verified date: February 2009
• Source: Santa Clara Valley Health & Hospital System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Other:
• laser trabeculoplasty
Deliver laser energy to the trabecular meshwork using the Pascal Laser System

Locations

Country	Name	City	State
United States	Santa Clara Valley Medical Center	San Jose	California

Sponsors (2)

Lead Sponsor	Collaborator
Santa Clara Valley Health & Hospital System	OptiMedica Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraocular pressure		1 week, 1 month, 3 months, 6 months, 9 months and 1 year after treatment	No