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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct Selective Laser Trabeculoplasty (DSLT) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months post-procedure |
| Proportion of Patients Who Are Medication-Free |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ngoc Nguyen, M.D. | Contact | 4082723706 | ngocyu@hotmail.com | |
| Lauren Nguyen | Contact | 4086092569 | laurenhtnguyen@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ngoc Nguyen M.D. | San Jose | California | 95116 | United States |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 15, 2025 | Dec 18, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 11, 2025 | Dec 18, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D057066 | Low Tension Glaucoma |
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D009901 | Optic Nerve Diseases |
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Proportion of participants who require zero topical glaucoma medications at 11 months after DSLT treatment. |
| 12 months post-procedure |