Normal Tension Glaucoma (NTG)NCT07300852
DSLT in Normal Tension Glaucoma (NTG) Asian Eyes
A study testing Direct Selective Laser Trabeculoplasty (DSLT) in people with Normal Tension Glaucoma (NTG) and Glaucoma, run by Ngoc Nguyen Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of direct selective laser trabeculoplasty (DSLT) or laser treatment in Asian patients with normal tension glaucoma. The main question it aims to answer is: Does the DSLT reduce intraocular pressure (IOP) and medication use in Asian NTG subjects? Participants… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Normal Tension Glaucoma (NTG), Glaucoma, Open Angle Glaucoma (OAG)
- What is being tested?
- Direct Selective Laser Trabeculoplasty (DSLT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asian descent
- NTG diagnosis: glaucomatous optic neuropathy in patients with IOP measurements consistently lower than 21 mmHg
- Mean deviation (MD) of the visual field between 0 to -12dB
- No significant central vision loss within 5 degrees within 5th percentile
- Age ≥20 years
- NTG patients who are medically controlled on 1-3 medications and safe to wash out or IOP is still insufficient from medications and safe to washout
Show all 9Show fewer
- Shaffer grade II or more on 3 of the 4 quadrants
- Central corneal thickness (CCT) 450-600µm
- All participants are able to provide written informed consent before participation
Who cannot join
- Angle closure glaucoma or narrow angle status post laser peripheral iridotomy (LPI), or any other open angle glaucoma excluding NTG
- History of SLT within last 2 years
- History intraocular surgery including refractive surgery, except for history of cataract surgery that has been greater than 1 year
- Patients anticipating cataract surgery during the study follow-up period
- Unable to have DSLT procedure due to pre-limbal findings
- Any presence of relevant ocular diseases including retinal disease with no confirmed cure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Ngoc Nguyen M.D.
San Jose, California, 95116
Lauren Nguyen, 4086092569, laurenhtnguyen@gmail.com
About this study
Official title: The Effectiveness of DSLT in Asian Normal Tension Glaucoma Patients
The goal of this clinical trial is to evaluate the efficacy of direct selective laser trabeculoplasty (DSLT) or laser treatment in Asian patients with normal tension glaucoma. The main question it aims to answer is:
Does the DSLT reduce intraocular pressure (IOP) and medication use in Asian NTG subjects? Participants will attend routine follow-up visits with their eye surgeon and glaucoma testing such as optical coherence tomography (OCT) imaging and visual field test(s) after the laser study treatment.
- Being tested
- Direct Selective Laser Trabeculoplasty (DSLT)
- Keywords
- DSLT, Direct Selective Laser Trabeculoplasty, NTG, Glaucoma, Normal Tension Glaucoma, BELKIN Vision Eagle, Glaucoma laser treatment, Asian glaucoma, Intraocular pressure, SLT alternative, Glaucoma medications reduction
- Medical subject headings
- Low Tension Glaucoma, Glaucoma, 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
Also called BELKIN Vision Eagle, Non-contact SLT, DSLT Laser Treatment, Direct Selective Laser Trabeculoplasty
Direct Selective Laser Trabeculoplasty (DSLT) is a non-contact laser procedure that delivers energy to the trabecular meshwork without the need for a gonioscopy lens. The BELKIN Vision Eagle device automatically aligns and applies laser pulses to lower intraocular pressure in subjects with normal tension glaucoma. All participants receive a single DSLT treatment followed by routine post-procedure evaluations including IOP checks, visual field testing, and OCT imaging.
| Study group | Role | What they receive |
|---|---|---|
| DSLT Treatment Arm | Experimental | Participants will receive Direct Selective Laser Trabeculoplasty (DSLT) using the BELKIN Vision Eagle device. The procedure is performed without a contact lens and delivers non-contact laser energy to the trabecular meshwork to lower intraocular pressure. All participants undergo standard pre- and post-procedure evaluations, including IOP measurements, visual field testing, and OCT imaging. Receives: Device: Direct Selective Laser Trabeculoplasty (DSLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure (IOP)
Absolute change in washed-out intraocular pressure (IOP) at 12 months compared to washed-out baseline IOP. Following a 6-week washout at baseline and again at month 11, IOP will be measured using standard tonometry to assess the effect of Direct Selective Laser Trabeculoplasty (DSLT) on pressure reduction.
Measured: 12 months post procedure
Secondary outcomes (2)
Number of Glaucoma Medications Reduced
Change in the number of topical glaucoma medications required to control intraocular pressure at 11 months compared to baseline, to evaluate whether DSLT decreases medication burden.
Measured: 12 months post-procedure
Proportion of Patients Who Are Medication-Free
Proportion of participants who require zero topical glaucoma medications at 11 months after DSLT treatment.
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Tension Glaucoma (NTG)Studies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ngoc Nguyen Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Ngoc Nguyen M.D., Ngoc Nguyen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300852
- Sponsor's protocol ID
- NTG_DSLT-001
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) for this study. The sample size is small and sharing de-identified datasets may not adequately protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of DSLT in Asian Normal Tension Glaucoma Patients
- ClinicalTrials.gov ID
- NCT07300852
- Acronym / sponsor ID
- NTG_DSLT-001
- Keywords
- DSLT, Direct Selective Laser Trabeculoplasty, NTG, Glaucoma, Normal Tension Glaucoma, BELKIN Vision Eagle, Glaucoma laser treatment, Asian glaucoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ngoc Nguyen Inc.University, hospital or other
- Collaborators
- Alcon Research
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 24 Dec 2025 (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 goal of this clinical trial is to evaluate the efficacy of direct selective laser trabeculoplasty (DSLT) or laser treatment in Asian patients with normal tension glaucoma. The main question it aims to answer is:
Does the DSLT reduce intraocular pressure (IOP) and medication use in Asian NTG subjects? Participants will attend routine follow-up visits with their eye surgeon and glaucoma testing such as optical coherence tomography (OCT) imaging and visual field test(s) after the laser study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DSLT Treatment Arm | Experimental | Device: Direct Selective Laser Trabeculoplasty (DSLT)Participants will receive Direct Selective Laser Trabeculoplasty (DSLT) using the BELKIN Vision Eagle device. The procedure is performed without a contact lens and delivers non-contact laser energy to the trabecular meshwork to lower intraocular pressure. All participants undergo standard pre- and post-procedure evaluations, including IOP measurements, visual field testing, and OCT imaging. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Asian descent
- NTG diagnosis: glaucomatous optic neuropathy in patients with IOP measurements consistently lower than 21 mmHg
- Mean deviation (MD) of the visual field between 0 to -12dB
- No significant central vision loss within 5 degrees within 5th percentile
- Age ≥20 years
Key exclusion criteria (6 listed)
- Angle closure glaucoma or narrow angle status post laser peripheral iridotomy (LPI), or any other open angle glaucoma excluding NTG
- History of SLT within last 2 years
- History intraocular surgery including refractive surgery, except for history of cataract surgery that has been greater than 1 year
- Patients anticipating cataract surgery during the study follow-up period
- Unable to have DSLT procedure due to pre-limbal findings
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)Also: BELKIN Vision Eagle, Non-contact SLT, DSLT Laser Treatment, Direct Selective Laser TrabeculoplastyDirect Selective Laser Trabeculoplasty (DSLT) is a non-contact laser procedure that delivers energy to the trabecular meshwork without the need for a gonioscopy lens. The BELKIN Vision Eagle device automatically aligns and applies laser pulses to lower intraocular pressure in subjects with normal tension glaucoma. All participants receive a single DSLT treatment followed by routine post-procedure evaluations including IOP checks, visual field testing, and OCT imaging. | Device | DSLT Treatment Arm |
Primary outcome
Change in Intraocular Pressure (IOP)
Time frame: 12 months post procedure
Absolute change in washed-out intraocular pressure (IOP) at 12 months compared to washed-out baseline IOP. Following a 6-week washout at baseline and again at month 11, IOP will be measured using standard tonometry to assess the effect of Direct Selective Laser Trabeculoplasty (DSLT) on pressure reduction.
2 secondary outcomes
Number of Glaucoma Medications Reduced
Time frame: 12 months post-procedure
Proportion of Patients Who Are Medication-Free
Time frame: 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) for this study. The sample size is small and sharing de-identified datasets may not adequately protect participant privacy.
Related trials for Normal Tension Glaucoma (NTG)
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Neuro-Ophthalmology, Optic Neuropathies
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.
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) in people with Normal Tension Glaucoma (NTG) and Glaucoma, run by Ngoc Nguyen Inc. 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 9 inclusion and 6 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: opening soon, as of the sponsor's last update on 24 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ngoc Nguyen, M.D. (4082723706, ngocyu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intraocular Pressure (IOP) (time frame: 12 months post procedure). 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 24 Dec 2025.