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| ID | Type | Description | Link |
|---|---|---|---|
| UG1EY031651 | U.S. NIH Grant/Contract | View source | |
| UG1EY031654 | U.S. NIH Grant/Contract | View source | |
| STUDY21080018 | Other Identifier | University of Pittsburgh |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| West Virginia University | OTHER |
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The goal of this study is to understand if SLT performed at low energy is as effective as SLT performed at standard energy, and also to see if repeating SLT at low energy once a year will prevent or delay the need for daily eye drop medications better than waiting for SLT to wear off before repeating it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial 1: Initial standard energy SLT | Active Comparator | Standard energy SLT is performed as follows: beginning at 0.8 mJ, energy will be titrated up or down within the first 5-10 spots until champagne bubbles are visualized with every 2nd or 3rd spot. Energy can be titrated throughout the procedure, in response to variations in pigmentation, to ensure the appearance of champagne bubbles with every 2nd or 3rd spot throughout the full 360° treatment. Energy should be increased if no bubbles are seen with 5 consecutive spots and decreased if bubbles are seen with 5 consecutive spots. |
|
| Trial 2: Month 12 Randomization: Annual Low Energy Repeat SLT | Experimental | At month 12, eligible subjects will be randomized to undergo repeat SLT either annually at low energy or as needed at standard energy. Low energy SLT will consist of 100 treatment spots delivered at 0.4 mJ per spot throughout the full 360° treatment, with the exception that energy can be reduced to 0.3 mJ if bubbles are seen with 5 consecutive spots and can be increased back to a maximum of 0.4mJ is no bubbles are seen with 5 consecutive spots. |
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| Trial 2: Month 12 Randomization: As-Needed Repeat SLT at Standard Energy | Active Comparator | At month 12, eligible subjects will be randomized to undergo repeat SLT either annually at low energy or as needed at standard energy. Standard SLT will be performed as follows: beginning at 0.8 mJ, energy will be titrated up or down within the first 5-10 spots until champagne bubbles are visualized with every 2nd or 3rd spot. Energy can be titrated throughout the procedure, in response to variations in pigmentation, to ensure the appearance of champagne bubbles with every 2nd or 3rd spot throughout the full 360° treatment. Energy should be increased if no bubbles are seen with 5 consecutive spots and decreased if bubbles are seen with 5 consecutive spots. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Energy SLT | Procedure | SLT performed at low energy |
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| Measure | Description | Time Frame |
|---|---|---|
| 12-month survival | Survival of first SLT through Month 12 | 12 months |
| 48-month survival | At Month 12, subjects are randomized to repeat SLT either annually at low energy or PRN at standard energy. The proportion controlled with SLT alone at Month 48 will be compared between groups | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP | Mean IOP at month 12 | 12 months |
| Long-term mean IOP | Mean IOP at each study visit | 12, 24, 36, and 48 months |
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Inclusion Criteria:
Age 18 or older and in good health
Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes):
Each eye with BCVA 20/200 (UK 6/60) or better
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tony Realini, MD, MPH | Contact | 3045986926 | hypotonywvu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tony Realini, MD, MPH | West Virginia University | Study Chair |
| Goundappa K Balasubramani, PhD | University of Pittsburgh | Principal Investigator |
| Stephen Wisniewski, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Eye Associates | Recruiting | Laguna Hills | California | 92653 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33428350 | Background | Realini T, Gazzard G, Latina M, Kass M. Low-energy Selective Laser Trabeculoplasty Repeated Annually: Rationale for the COAST Trial. J Glaucoma. 2021 Jul 1;30(7):545-551. doi: 10.1097/IJG.0000000000001788. |
| Label | URL |
|---|---|
| Study website | View source |
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All study data will be de-identified. We will invite other investigators to submit secondary data requests using the data from the study and will work with those investigators to foster additional research studies and manuscripts. The investigators agree to abide by the principles for sharing research resources as described by "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources." All publications based on the study will adhere to the NIH Public Access Policy (Notice NOT-OD-08-033). At the end of the study, all study data will be submitted for permanent archive per the notice of grant award.
At study completion
See above
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The COAST trial underwent a design modification in response to a planned interim analysis. The original and current designs are described here.
Initial Design: Subjects are randomized at study entry to initial SLT at standard or low energy. Subjects who reach Month 12 without discontinuing study treatment are randomized a second time to annual low-energy repeat SLT or as-needed standard energy repeat SLT. There are 2 arms in the first 12 months of the study and 2 arms in Months 13-48.
Current deign: Subjects receive standard at SLT at study entry. Subjects who reach Month 12 without discontinuing study treatment are randomized to annual low-energy repeat SLT or as-needed standard energy repeat SLT. There are 2 arms in the first 12 months of the study and 2 arms in Months 13-48.
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| Trial 1: Initial Low Energy SLT | Experimental | Note: This arm was discontinued following a planned interim analysis. Low energy SLT will consist of 100 treatment spots delivered at 0.4 mJ per spot throughout the full 360° treatment, with the exception that energy can be reduced to 0.3 mJ if bubbles are seen with 5 consecutive spots and can be increased back to a maximum of 0.4mJ if no bubbles are seen with 5 consecutive spots. |
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| Standard Energy SLT | Procedure | SLT performed at standard energy |
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| Incidence of IOP spikes | IOP spikes > 5 mmHg on day of SLT | 0, 12, 24, 36, and 48 months |
| University of Pittsburgh |
| Principal Investigator |
| Doheny Eye Center UCLA | Recruiting | Pasadena | California | 91105 | United States |
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| University of California, Davis | Recruiting | Sacramento | California | 95817 | United States |
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| University of California, San Francisco | Recruiting | San Francisco | California | 94158 | United States |
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| Mile High Eye Institute | Recruiting | Sheridan | Colorado | 80110 | United States |
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| Clear Vue Laser Eye Center | Recruiting | Lakeworth | Florida | 33467 | United States |
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| Northwestern Medical Group | Recruiting | Chicago | Illinois | 60615 | United States |
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| Chicago Arbor Eye Institute | Recruiting | Orland Park | Illinois | 60467 | United States |
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| Illinois Eye Center | Recruiting | Peoria | Illinois | 61615 | United States |
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| Wilmer Eye Institute Johns Hopkins | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Massachusetts Eye and Ear | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Ophthalmic Consultants of Boston | Recruiting | Boston | Massachusetts | 02451 | United States |
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| Mark Latina, LLC | Recruiting | Reading | Massachusetts | 01867 | United States |
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| University of Michigan Kellogg Eye Center | Recruiting | Ann Arbor | Michigan | 48105 | United States |
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| Kresge Eye Institute Wayne State University | Recruiting | Detroit | Michigan | 48201 | United States |
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| New York Eye Surgery Associates | Recruiting | The Bronx | New York | 10469 | United States |
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| University Hospitals Eye Institute | Recruiting | Cleveland | Ohio | 44106 | United States |
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| Cleveland Clinic Cole Eye Institute | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Devers Eye Institute | Recruiting | Portland | Oregon | 97210 | United States |
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| Eye Care Specialists | Recruiting | Kingston | Pennsylvania | 18704 | United States |
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| Scheie Eye Institute | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Wills Eye Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| UPMC Eye Center | Active, not recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt Eye Institute | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Ophthalmology Associates | Recruiting | Fort Worth | Texas | 76102 | United States |
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| Spokane Eye Clinical Research | Recruiting | Spokane | Washington | 99204 | United States |
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| West Virginia University | Recruiting | Morgantown | West Virginia | 26505 | United States |
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| University of Wisconsin-Madison | Recruiting | Madison | Wisconsin | 53705 | United States |
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| Ocular Health Centre | Active, not recruiting | Kitchener | Ontario | N2A0K5 | Canada |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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