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The objective of this study is to evaluate the safety and effectiveness of Direct Selective Laser Trabeculoplasty (DSLT) in ethnic Chinese participants with Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OHT), or Normal Tension Glaucoma (NTG).
After informed consent is obtained, potential study participants will undergo a hypotensive medication washout period as applicable. Patients will then be re-assessed for eligibility and treated with DSLT if they meet the inclusion/exclusion criteria. The first 5 patients will be treated 360 degrees with laser energy of 1.2 millijoule (mJ) (Group 1). If all 5 Group 1 patients pass the pre-defined safety endpoint at Week 1, then the next 40 patients will be treated 360 degrees with laser energy of 1.8 mJ (Group 2). Patients will attend one treatment visit and up to 9 follow-up visits, remotely or at the clinic. Individual duration of participation is approximately 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSLT with Eagle (Group 1) | Experimental | Single treatment 360 degrees with laser energy of 1.2 mJ |
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| DSLT with Eagle (Group 2) | Experimental | Single treatment 360 degrees with laser energy of 1.8 mJ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Automatic Glaucoma Laser | Device | Trans-limbal, direct selective laser trabeculoplasty (DSLT) instrument that directs laser energy through the sclera around the limbus overlying the trabecular meshwork and treats 360 degrees of the angle is treated simultaneously |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in IOP at Month 6 | Intraocular pressure (IOP) will be assessed with Goldmann applanation tonometry and recorded in millimeters mercury (mmHg). Change from baseline is defined as the difference between baseline (washed out for medicated patients) IOP and (washed out for medicated patients) IOP measured at Month 6 for each participant enrolled in the study. A negative change from baseline will represent an improvement. | Baseline (Day -7 to 0) (post washout and pretreatment), Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Reduction from Baseline in IOP at Month 6 and Month 12 | Intraocular pressure (IOP) will be assessed with Goldmann applanation tonometry and recorded in millimeters mercury (mmHg). Change from baseline is defined as the difference between baseline (washed out for medicated patients) IOP and (washed out for medicated patients) IOP measured at the respective timepoints (Month 6 and Month 12). A positive percent reduction will represent an improvement. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorit Raz Prag | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C-Mer Eye Clinic | Hong Kong | China | ||||
| SERI |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D057066 | Low Tension Glaucoma |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D009901 | Optic Nerve Diseases |
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|
| Direct Selective Laser Trabeculoplasty | Procedure | Surgical procedure that utilizes a laser to improve fluid drainage in the eye and reduce intraocular pressure |
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| Baseline (Day -7 to 0) (post washout and pretreatment), Month 6, Month 12 |
| Proportion of Subjects with at least 20 percent reduction in IOP from Baseline in IOP for POAG and OHT and at least 15 percent reduction in IOP for NTG at Month 6 with no Secondary Surgical Intervention (SSI) or Inability to Washout | Intraocular pressure (IOP) will be assessed with Goldmann applanation tonometry and recorded in millimeters mercury (mmHg). A secondary surgical intervention (SSI) is defined as a procedure in addition to DSLT that is conducted to manage/lower IOP. A higher proportion with the specified reduction will represent an improvement. | Baseline (Day -7 to 0) (post washout and pretreatment), Month 6, Month 12 |
| Change from Baseline in Number of Glaucoma Medications at Month 6 and Month 12 | The number of glaucoma-related medications in use will be recorded. For medicated subjects, the Screening visit is considered baseline. For naïve (unmedicated) subjects, Visit 1 is considered baseline. | Screening (Day -45 to -1) (prewashout and pretreatment)/Visit 1 (Day 0) (pretreatment), Month 6, Month 12 |
| Singapore |
| Singapore |