Open Angle GlaucomaNCT04758598
The Effects of DSLT and SLT on the Corneal Endothelium: A GLAUrious Trial Sub-Study
A study testing Direct Selective Laser Trabeculoplasty (DSLT) and Selective Laser Trabeculoplasty (SLT) in people with Open Angle Glaucoma, run by BelkinVision at 1 site in Georgia.
Trial summary
The objective of this study is to compare the long-term (6 months) effects of Direct Selective Laser Trabeculoplasty (DSLT) treatment and SLT (Selective Laser Trabeculoplasty) treatment on corneal endothelial cell counts and corneal thickness. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Direct Selective Laser Trabeculoplasty (DSLT) and Selective Laser Trabeculoplasty (SLT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGeorgia
- Study dates
- 1 Mar 2021to 6 May 2022
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 years or older, with visual acuity > 6/60 in both eyes
- Open angle glaucoma including exfoliative or pigmentary glaucoma or ocular hypertension.
- IOP ≥ 22mmHg or ≤35mmHg (after washout of any IOP-lowering medications) for participants with open angle glaucoma or IOP ≥ 24mmHg to ≤35mmHg (after washout of any IOP-lowering medications) for participants with ocular hypertension
- Gonioscopically visible scleral spur for 360 degrees without indentation
- Ability to visualize the peri-limbal sclera for 360 degrees (using a speculum)
- Willing and able to participate in the 12-month study, to comply with the study procedures and to adhere to the follow-up schedule.
- Participant capable of giving informed consent
Who cannot join
- Contraindications to conventional laser trabeculoplasty (e.g. corneal abnormalities etc.)
- Angle Closure Glaucoma
- Congenital or developmental glaucoma
- Secondary glaucoma except exfoliative or pigmentary glaucoma
- Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%)
- Presence of any Peripheral Anterior Synechiae (PAS) in the study eye
Show all 26Show fewer
- Any of the following visual field findings using the Humphrey visual field analyzer the SITA-standard 24-2 program:
- A visual field MD of worse than -12dB
- Greater than or equal to 75% of points depressed below the 5% level and greater than or equal to 50% of points depressed below the 1% level on the PD plot
- At least 50% of points (i.e., 2 or more) within the central 5 degrees with a sensitivity ≤0dB on the decibel plot
- Points within the central 5 degrees of fixation with a sensitivity <15 dB in both hemifields on the decibel plot
- A visual field MD of worse than -12dB in the fellow eye
- Cup:Disc Ratio more than 0.8
- More than three hypotensive medications required (combination drops are considered 2 medications)
- Prior incisional or laser glaucoma surgery (including previous SLT) in the study eye
- Prior corneal refractive surgery
- Complicated cataract surgery ≤ 6 months prior to enrollment
- Presence of visually significant cataract in the opinion of the investigator
- Clinically significant disease in either eye as determined by the Investigator
- Clinically significant amblyopia in either eye
- Dense pigmentation or haemorrhage in the peri-limbal conjunctiva or anterior sclera
- Women who are pregnant or may become pregnant during the course of the study
- In the opinion of the investigator the participant might require other ocular surgery within the 12-month follow-up period, unless for further reduction of their IOP.
- Concurrent treatment with topical, nasal, inhaled or systemic steroids.
- Uncontrolled systemic disease that could impact the ability of the participant to attend follow up visits as per the discretion of the investigator
- Participation in another clinical study, not including a GLAUrious sub-study
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to compare the long-term (6 months) effects of Direct Selective Laser Trabeculoplasty (DSLT) treatment and SLT (Selective Laser Trabeculoplasty) treatment on corneal endothelial cell counts and corneal thickness.
Read the detailed description
Rational:
SLT has known transient effect on corneal endothelial cell (CEC) counts yet no data is yet available with DSLT.
This study is relevant as the DSLT treatment area is at the limbus: CEC progenitor site
- Conditions
- Open Angle Glaucoma
- Being tested
- Direct Selective Laser Trabeculoplasty (DSLT), Selective Laser Trabeculoplasty (SLT)
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Selective Laser Trabeculoplasty (DSLT)Device
DSLT employs frequency-doubled, Q-switched Nd:YAG laser with a wavelength of 532 nm. During the procedure, a laser beam targets the trabecular meshwork (TM) - to improve intraocular fluid outflow. The laser beam is delivered in short nanosecond pulses and the selective cellular effect occurs at the pigmented cells of the TM. This increases the permeability of the TM endothelial cells and thereby increases outflow, resulting in reductions in IOP. In contrast to SLT, the DSLT treatment directs the laser beam directly through the sclera around the limbus without the need for a delivery device (gonioscope lens). Laser treatment lasts for about 2 seconds with about 120 laser shots delivered to the sclera around the limbus.
Selective Laser Trabeculoplasty (SLT)Device
SLT employs frequency doubled Q switched Nd:YAG laser with a wavelength of 532 nm. It is delivered in short nano second pulses and the resulting selective effect to the pigmented cells of the TM, leaving the surrounding non-pigmented cells unaffected. This increases the permeability of the TM endothelial cells and can assist in increasing outflow and hence result in reductions in IOP. The procedure lasts approximately 10 minutes, with delivering 100 separate laser beams through a manually rotated mirrored lens (gonioscope), involving prolonged contact with the participant's eye. This treatment is applied on the cornea through a gonioscopic lens which is used to direct the laser beam to the desired location - the TM (360 degrees of treatment area).
| Study group | Role | What they receive |
|---|---|---|
| Direct Selective Laser Trabeculoplasty (DSLT) | Experimental | Direct Selective Laser Trabeculoplasty (DSLT): employs frequency-doubled, Q-switched Nd:YAG laser with a wavelength of 532 nm. During the procedure, a laser beam targets the trabecular meshwork (TM) - to improve intraocular fluid outflow. The laser beam is delivered in short nanosecond pulses and the selective cellular effect occurs at the pigmented cells of the TM. This increases the permeability of the TM endothelial cells and thereby increases outflow, resulting in reductions in IOP. In contrast to SLT, the DSLT treatment directs the laser beam directly through the sclera around the limbus without the need for a delivery device (gonioscope lens). Laser treatment lasts for about 2 seconds with about 120 laser shots delivered to the sclera around the limbus. Receives: Device: Direct Selective Laser Trabeculoplasty (DSLT) |
| Selective Laser Trabeculoplasty (SLT) | Active comparator | SLT employs frequency doubled Q switched Nd:YAG laser with a wavelength of 532 nm. It is delivered in short nano second pulses and the resulting selective effect to the pigmented cells of the TM, leaving the surrounding non-pigmented cells unaffected. This increases the permeability of the TM endothelial cells and can assist in increasing outflow and hence result in reductions in IOP. The procedure lasts approximately 10 minutes, with delivering 100 separate laser beams through a manually rotated mirrored lens (gonioscope), involving prolonged contact with the participant's eye. This treatment is applied on the cornea through a gonioscopic lens which is used to direct the laser beam to the desired location - the TM (360 degrees of treatment area). Receives: Device: Selective Laser Trabeculoplasty (SLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the mean baseline and 6 month central corneal thickness, DSLT vs SLT
Central corneal thickness will be assessed by pachymetry
Measured: 6 months
Difference between the mean baseline and 6 month corneal endothelial cell count, DSLT vs SLT
Corneal endothelial cell count will be assessed with specular microscopy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Mar 2021
- Primary completion15 Apr 2022
- Study completion6 May 2022
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- DSLT treatment vs. SLT treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BelkinVision
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758598
- Sponsor's protocol ID
- 2020-01
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2021
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to share the protocol, statistical plan and results
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of DSLT and SLT on the Corneal Endothelium: A GLAUrious Trial Sub-Study
- ClinicalTrials.gov ID
- NCT04758598
- Acronym / sponsor ID
- 2020-01
- Conditions
- Open Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BelkinVisionIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 17 Feb 2021 (actual)
- 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.
The objective of this study is to compare the long-term (6 months) effects of Direct Selective Laser Trabeculoplasty (DSLT) treatment and SLT (Selective Laser Trabeculoplasty) treatment on corneal endothelial cell counts and corneal thickness.
Detailed description
Rational:
SLT has known transient effect on corneal endothelial cell (CEC) counts yet no data is yet available with DSLT.
This study is relevant as the DSLT treatment area is at the limbus: CEC progenitor site
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- DSLT treatment vs. SLT treatment
| Arm | Type | Receives |
|---|---|---|
| Direct Selective Laser Trabeculoplasty (DSLT) | Experimental | Device: Direct Selective Laser Trabeculoplasty (DSLT)Direct Selective Laser Trabeculoplasty (DSLT): employs frequency-doubled, Q-switched Nd:YAG laser with a wavelength of 532 nm. During the procedure, a laser beam targets the trabecular meshwork (TM) - to improve intraocular fluid outflow. The laser beam is delivered in short nanosecond pulses and the selective cellular effect occurs at the pigmented cells of the TM. This increases the permeability of the TM endothelial cells and thereby increases outflow, resulting in reductions in IOP. In contrast to SLT, the DSLT treatment directs the laser beam directly through the sclera around the limbus without the need for a delivery device (gonioscope lens). Laser treatment lasts for about 2 seconds with about 120 laser shots delivered to the sclera around the limbus. |
| Selective Laser Trabeculoplasty (SLT) | Active comparator | Device: Selective Laser Trabeculoplasty (SLT)SLT employs frequency doubled Q switched Nd:YAG laser with a wavelength of 532 nm. It is delivered in short nano second pulses and the resulting selective effect to the pigmented cells of the TM, leaving the surrounding non-pigmented cells unaffected. This increases the permeability of the TM endothelial cells and can assist in increasing outflow and hence result in reductions in IOP. The procedure lasts approximately 10 minutes, with delivering 100 separate laser beams through a manually rotated mirrored lens (gonioscope), involving prolonged contact with the participant's eye. This treatment is applied on the cornea through a gonioscopic lens which is used to direct the laser beam to the desired location - the TM (360 degrees of treatment area). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 40 years or older, with visual acuity > 6/60 in both eyes
- Open angle glaucoma including exfoliative or pigmentary glaucoma or ocular hypertension.
- IOP ≥ 22mmHg or ≤35mmHg (after washout of any IOP-lowering medications) for participants with open angle glaucoma or IOP ≥ 24mmHg to ≤35mmHg (after washout of any IOP-lowering medications) for participants with ocular hypertension
- Gonioscopically visible scleral spur for 360 degrees without indentation
- Ability to visualize the peri-limbal sclera for 360 degrees (using a speculum)
Key exclusion criteria (26 listed)
- Contraindications to conventional laser trabeculoplasty (e.g. corneal abnormalities etc.)
- Angle Closure Glaucoma
- Congenital or developmental glaucoma
- Secondary glaucoma except exfoliative or pigmentary glaucoma
- Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%)
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 |
|---|---|---|
| Direct Selective Laser Trabeculoplasty (DSLT)DSLT employs frequency-doubled, Q-switched Nd:YAG laser with a wavelength of 532 nm. During the procedure, a laser beam targets the trabecular meshwork (TM) - to improve intraocular fluid outflow. The laser beam is delivered in short nanosecond pulses and the selective cellular effect occurs at the pigmented cells of the TM. This increases the permeability of the TM endothelial cells and thereby increases outflow, resulting in reductions in IOP. In contrast to SLT, the DSLT treatment directs the laser beam directly through the sclera around the limbus without the need for a delivery device (gonioscope lens). Laser treatment lasts for about 2 seconds with about 120 laser shots delivered to the sclera around the limbus. | Device | Direct Selective Laser Trabeculoplasty (DSLT) |
| Selective Laser Trabeculoplasty (SLT)SLT employs frequency doubled Q switched Nd:YAG laser with a wavelength of 532 nm. It is delivered in short nano second pulses and the resulting selective effect to the pigmented cells of the TM, leaving the surrounding non-pigmented cells unaffected. This increases the permeability of the TM endothelial cells and can assist in increasing outflow and hence result in reductions in IOP. The procedure lasts approximately 10 minutes, with delivering 100 separate laser beams through a manually rotated mirrored lens (gonioscope), involving prolonged contact with the participant's eye. This treatment is applied on the cornea through a gonioscopic lens which is used to direct the laser beam to the desired location - the TM (360 degrees of treatment area). | Device | Selective Laser Trabeculoplasty (SLT) |
Primary outcome
Difference between the mean baseline and 6 month central corneal thickness, DSLT vs SLT
Time frame: 6 months
Central corneal thickness will be assessed by pachymetry
Difference between the mean baseline and 6 month corneal endothelial cell count, DSLT vs SLT
Time frame: 6 months
Corneal endothelial cell count will be assessed with specular microscopy
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 17 Jan 2023.
- Individual participant dataSharing planned: Undecided. We plan to share the protocol, statistical plan and results
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Selective Laser Trabeculoplasty (DSLT) and Selective Laser Trabeculoplasty (SLT) in people with Open Angle Glaucoma, run by BelkinVision at 1 site in Georgia.
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 7 inclusion and 26 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 17 Jan 2023. 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 Georgia. 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?
Difference between the mean baseline and 6 month central corneal thickness, DSLT vs SLT (time frame: 6 months). The study lists 2 primary outcomes in all. 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 17 Jan 2023.