Open Angle GlaucomaPLTNCT00838721
Evaluation of Pascal Laser Trabeculoplaty
A study testing laser trabeculoplasty in people with Open Angle Glaucoma and Ocular Hypertension, run by Santa Clara Valley Health & Hospital System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- laser trabeculoplasty
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Santa Clara Valley Medical Center
San Jose, California, 95128
About this study
Official title: 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.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- laser trabeculoplasty
- Keywords
- Open Angle Glaucoma, Ocular Hypertension, Laser Trabeculoplasty
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser trabeculoplastyOther
Deliver laser energy to the trabecular meshwork using the Pascal Laser System
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure
Measured: 1 week, 1 month, 3 months, 6 months, 9 months and 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Clara Valley Health & Hospital System
- Sponsor type
- University, hospital or other
- Collaborators
- OptiMedica Corporation
- Responsible party
- Sponsor
- Investigators
- Christopher J Engelman, MD, Principal investigator, Santa Clara Valley Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838721
- Sponsor's protocol ID
- PASCAL-1
- Acronym
- PLT
- Status last verified
- Feb 2009
- First submitted
- 5 Feb 2009
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Efficacy of Pascal Trabeculoplasty: A Pilot Study
- ClinicalTrials.gov ID
- NCT00838721
- Acronym / sponsor ID
- PLT / PASCAL-1
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Open Angle Glaucoma, Ocular Hypertension, Laser Trabeculoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Santa Clara Valley Health & Hospital SystemUniversity, hospital or other
- Collaborators
- OptiMedica Corporation
- Study start
- Mar 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser trabeculoplastyDeliver laser energy to the trabecular meshwork using the Pascal Laser System | Other | – |
Primary outcome
intraocular pressure
Time frame: 1 week, 1 month, 3 months, 6 months, 9 months and 1 year after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Engelman, MD principal investigator
Santa Clara Valley Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser trabeculoplasty in people with Open Angle Glaucoma and Ocular Hypertension, run by Santa Clara Valley Health & Hospital System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure (time frame: 1 week, 1 month, 3 months, 6 months, 9 months and 1 year after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.