Open Angle GlaucomaNCT01342406
Effects of Selective Laser Trabeculoplasty on Aqueous Humor Dynamics
An observational study of Open Angle Glaucoma, run by University of Nebraska at 2 sites in United States.
Trial summary
This study will compare aqueous humor dynamics in adults with primary open angle glaucoma that receive Selective Laser Trabeculoplasty (SLT). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Open Angle Glaucoma
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2010to 1 Nov 2013
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with open angle glaucoma
Who may be able to join
- 40 years of age and older
- Eye consideration for SLT (intraocular pressure above target with current medications, intolerance/allergy to topical medications, patient preference as primary treatment)
- Open angles on gonioscopy
Who cannot join
- Any previous surgical or laser procedures
- Secondary glaucoma including pigmentary, exfoliative, uveitic, and traumatic glaucomas
- Corneal opacities interfering with adequate fluorophotometry
- Any active ocular infection within the past 2 months
- Any corneal pathology increasing the likelihood of corneal abrasions
- Inability to safely washout medications prior to laser treatment
- Allergies to fluorescein, timolol, dorzolamide, or sulfa
- Excessive (3+) trabecular meshwork pigmentation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Nebraska Medical Center, Department of Ophthalmology
Omaha, Nebraska, 68198-5540
University of Nebraska Medical Center, Department of Ophthalmology
Omaha, Nebraska, 68198
About this study
This study will compare aqueous humor dynamics in adults with primary open angle glaucoma that receive Selective Laser Trabeculoplasty (SLT).
Read the detailed description
Describe the background of the study. Include a critical evaluation of existing knowledge, and specifically identify the information gaps that the project is intended to fill.
Laser trabeculoplasty is currently a well established treatment option for lowering the intraocular pressure in the management of open angle glaucoma1,2. The procedure involves placement of laser spots over the trabecular meshwork, possibly through a variety of laser types. Argon laser trabeculoplasty (ALT) has been the most widely utilized option for laser trabeculoplasty over the past few decades. Since its availability approximately a decade ago, Selective Laser Trabeculoplasty (SLT) is currently an additional option for doing laser trabeculoplasty. 3,4. Current evidence suggests that SLT achieves its interocular pressure (IOP) lowering effect without thermal damage to the trabecular meshwork5. The IOP lowering effect of SLT has been shown to be comparable to ALT over the long term6.
In physiological terms, ALT has been shown to lower the IOP primarily by increasing the conventional outflow facility7. There are two putative mechanisms by which this may be facilitated8. Thermal coagulation and shrinkage by ALT may mechanically open up the adjacent trabecular meshwork and Schlemm's canal. Alternatively the delivery of laser energy may trigger biological processes and activation of matrix metalloproteinases in the microenvironment of trabecular meshwork that lead to a remodeling of tissues resulting in improved outflow facility. ALT uses argon or another thermal laser to photocoagulate tissues around the trabecular meshwork. The settings vary depending on the tissue response and pigmentation. Most clinicians use 600-1500mW, 50-100 spots, 50 micron spot size and 0.1 sec duration.
Also, there is limited data on fluorophotometric and tonographic studies on ALT and none on SLT to the best of our knowledge. All available reference known to the investigators have been included in the list of references.
The effect of SLT on the aqueous humor dynamics is currently unknown. Given the lack of demonstrable thermal damage on histopathologic examination5, it is unlikely that the effects of SLT could be mechanically mediated. There has been some suggestion of a potential interaction of IOP lowering effect when prostaglandins and SLT are used together9,10. This suggests that there could be a possible sharing of mechanisms between SLT and prostaglandins. The IOP lowering effect of SLT may be mediated in part by effects on uveoscleral pathways in addition to the trabecular outflow pathway. This study will determine the changes in aqueous humor dynamics produced by SLT that lead to its IOP lowering effect. SLT is a Q switched frequency doubled Nd:YAG laser. The duration is 3 nanoseconds and spot size 500 microns. Power varies from 0.5-1.5 mJ and total number of spots can be between 50-over 100. The mechanism of action may be disruption of melanosomes, but this has not been unequivocally proven yet.
- Conditions
- Open Angle Glaucoma
- Medical subject headings
- Glaucoma, Open-Angle
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intraocular pressure (IOP) after Selective Laser Trabeculoplasty (SLT) and changes in outflow facility
This study will compare aqueous humor dynamics (intraocular pressure) in adults with primary open angle glaucoma that receive Selective Laser Trabeculoplasty (SLT).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study start1 Sep 2010
- Primary completion1 Nov 2013
- Study completion1 Nov 2013
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.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vikas Gulati, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342406
- Sponsor's protocol ID
- 0191-10-FB
- Status last verified
- Aug 2023
- First submitted
- 25 Apr 2011
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Selective Laser Trabeculoplasty on Aqueous Humor Dynamics
- ClinicalTrials.gov ID
- NCT01342406
- Acronym / sponsor ID
- 0191-10-FB
- Conditions
- Open Angle Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 1 Nov 2013 (actual)
- Study completion
- 1 Nov 2013 (actual)
- First posted
- 27 Apr 2011 (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.
This study will compare aqueous humor dynamics in adults with primary open angle glaucoma that receive Selective Laser Trabeculoplasty (SLT).
Detailed description
Describe the background of the study. Include a critical evaluation of existing knowledge, and specifically identify the information gaps that the project is intended to fill.
Laser trabeculoplasty is currently a well established treatment option for lowering the intraocular pressure in the management of open angle glaucoma1,2. The procedure involves placement of laser spots over the trabecular meshwork, possibly through a variety of laser types. Argon laser trabeculoplasty (ALT) has been the most widely utilized option for laser trabeculoplasty over the past few decades. Since its availability approximately a decade ago, Selective Laser Trabeculoplasty (SLT) is currently an additional option for doing laser trabeculoplasty. 3,4. Current evidence suggests that SLT achieves its interocular pressure (IOP) lowering effect without thermal damage to the trabecular meshwork5. The IOP lowering effect of SLT has been shown to be comparable to ALT over the long term6.
In physiological terms, ALT has been shown to lower the IOP primarily by increasing the conventional outflow facility7. There are two putative mechanisms by which this may be facilitated8. Thermal coagulation and shrinkage by ALT may mechanically open up the adjacent trabecular meshwork and Schlemm's canal. Alternatively the delivery of laser energy may trigger biological processes and activation of matrix metalloproteinases in the microenvironment of trabecular meshwork that lead to a remodeling of tissues resulting in improved outflow facility. ALT uses argon or another thermal laser to photocoagulate tissues around the trabecular meshwork. The settings vary depending on the tissue response and pigmentation. Most clinicians use 600-1500mW, 50-100 spots, 50 micron spot size and 0.1 sec duration.
Also, there is limited data on fluorophotometric and tonographic studies on ALT and none on SLT to the best of our knowledge. All available reference known to the investigators have been included in the list of references.
The effect of SLT on the aqueous humor dynamics is currently unknown. Given the lack of demonstrable thermal damage on histopathologic examination5, it is unlikely that the effects of SLT could be mechanically mediated. There has been some suggestion of a potential interaction of IOP lowering effect when prostaglandins and SLT are used together9,10. This suggests that there could be a possible sharing of mechanisms between SLT and prostaglandins. The IOP lowering effect of SLT may be mediated in part by effects on uveoscleral pathways in addition to the trabecular outflow pathway. This study will determine the changes in aqueous humor dynamics produced by SLT that lead to its IOP lowering effect. SLT is a Q switched frequency doubled Nd:YAG laser. The duration is 3 nanoseconds and spot size 500 microns. Power varies from 0.5-1.5 mJ and total number of spots can be between 50-over 100. The mechanism of action may be disruption of melanosomes, but this has not been unequivocally proven yet.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with open angle glaucoma
Key inclusion criteria (3 listed)
- 40 years of age and older
- Eye consideration for SLT (intraocular pressure above target with current medications, intolerance/allergy to topical medications, patient preference as primary treatment)
- Open angles on gonioscopy
Key exclusion criteria (8 listed)
- Any previous surgical or laser procedures
- Secondary glaucoma including pigmentary, exfoliative, uveitic, and traumatic glaucomas
- Corneal opacities interfering with adequate fluorophotometry
- Any active ocular infection within the past 2 months
- Any corneal pathology increasing the likelihood of corneal abrasions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in intraocular pressure (IOP) after Selective Laser Trabeculoplasty (SLT) and changes in outflow facility
Time frame: 3 years
This study will compare aqueous humor dynamics (intraocular pressure) in adults with primary open angle glaucoma that receive Selective Laser Trabeculoplasty (SLT).
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 6 Sep 2023.
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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.
Vikas Gulati, MD principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma, run by University of Nebraska at 2 sites 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 3 inclusion and 8 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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Changes in intraocular pressure (IOP) after Selective Laser Trabeculoplasty (SLT) and changes in outflow facility (time frame: 3 years). 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 6 Sep 2023.