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Clarifying the Optimal Application of SLT Therapy Trial (COAST)

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ClinicalTrials.gov Identifier: NCT04967989
Recruitment Status : Recruiting
First Posted : July 20, 2021
Last Update Posted : July 15, 2022
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Anthony Realini, West Virginia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glaucoma and Ocular Hypertension Procedure: Low Energy SLT Procedure: Standard Energy SLT Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects are randomized twice: the first, at study entry, to low energy or standard SLT; and the second, at Month 12, to annual or as-needed repeat SLT. There are 2 arms in the first 12 months of the study and 2 different arms in Months 13-48.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clarifying the Optimal Application of SLT Therapy Trial
Actual Study Start Date : September 22, 2021
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : August 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: First Randomization: Low Energy SLT

Low energy SLT will consist of 100 treatment spots delivered at 0.4mJ per spot throughout the full 360° treatment, with the exception that energy can be reduced to 0.3mJ 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.

Regardless of energy level randomization, energy may be adjusted downward in 0.1mJ increments throughout the procedure in response to factors such as heavy focal pigmentation or patient discomfort.

Procedure: Low Energy SLT
SLT performed at low energy

Active Comparator: First Randomization: Standard Energy SLT

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.

Regardless of energy level randomization, energy may be adjusted downward in 0.1mJ increments throughout the procedure in response to factors such as heavy focal pigmentation or patient discomfort.

Procedure: Standard Energy SLT
SLT performed at standard energy

Experimental: Second Randomization: Annual Low Energy Repeat SLT
At month 12, subjects remaining medication-free will be re-randomized to undergo repeat SLT either annually at low energy or as needed at initially assigned energy (from first randomization). The method of SLT delivery is as described in the sections above.
Procedure: Low Energy SLT
SLT performed at low energy

Active Comparator: Second Randomization: As-Needed Repeat SLT at Initial Energy
At month 12, subjects remaining medication-free will be re-randomized to undergo repeat SLT either annually at low energy or as needed at initially assigned energy (from first randomization). The method of SLT delivery is as described in the sections above.
Procedure: Low Energy SLT
SLT performed at low energy

Procedure: Standard Energy SLT
SLT performed at standard energy




Primary Outcome Measures :
  1. 12-month survival [ Time Frame: 12 months ]
    Survival of first SLT through Month 12

  2. 48-month medication-free survival [ Time Frame: 48 months ]
    At Month 12, subjects are re-randomized to repeat SLT either annually at low energy or PRN at initially-assigned energy. The proportion surviving medication-free at Month 48 will be compared between groups


Secondary Outcome Measures :
  1. Mean IOP [ Time Frame: 12 months ]
    Mean IOP at month 12

  2. Long-term mean IOP [ Time Frame: 12, 24, 36, and 48 months ]
    Mean IOP at each study visit

  3. Incidence of IOP spikes [ Time Frame: 0, 12, 24, 35, and 48 months ]
    IOP spikes > 5 mmHg on day of SLT



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. In good health, newly diagnosed and treatment naïve (no prior IOP-lowering treatments), with decision to treat made by an ophthalmologist on the basis of risk profile, patient preference, or both 3. Age 18 years or older 4. Each eye with BCVA at least 20/200 (UK 6/60) 5. Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes):

  1. High-risk ocular hypertension (OHT): IOP > 21 mmHg without glaucomatous optic neuropathy (excavation, diffuse or focal thinning or notching of the neuroretinal rim, visible nerve fiber layer defects, or asymmetry of the vertical cup-to-disc ratio of >0.2 between eyes) [enrollment of trial participants with High-risk OHT will be capped at 25% of total enrollment]
  2. Mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation >-6.0 dB with no points in the central 5° <15 dB
  3. Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation -6.0 dB to >-12 dB and no more than 1 central 5° point <15 dB

Exclusion Criteria:

  1. Advanced POAG in either eye
  2. Glaucoma other than POAG (including pigmentary and pseudoexfoliation glaucoma) in either eye
  3. Mean IOP > 35 mmHg at either the screening or baseline visit in either eye
  4. Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye
  5. Contraindications to SLT, brimonidine, or any other study intervention
  6. Any corneal pathology that would preclude accurate assessment of IOP by Goldmann tonometry in either eye
  7. Any intraocular surgical procedure within the past 6 months in either eye
  8. Inability to attend all scheduled study visits

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04967989


Contacts
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Contact: Tony Realini, MD, MPH 3045986926 hypotonywvu@gmail.com

Locations
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Sponsors and Collaborators
West Virginia University
University of Pittsburgh
Investigators
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Study Chair: Tony Realini, MD, MPH West Virginia University
Principal Investigator: Goundappa K Balasubramani, PhD University of Pittsburgh
Principal Investigator: Stephen Wisniewski, PhD University of Pittsburgh
Additional Information:
Publications:
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Responsible Party: Anthony Realini, Study Chair, West Virginia University
ClinicalTrials.gov Identifier: NCT04967989    
Other Study ID Numbers: UG1EY031654 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: At study completion
Access Criteria: See above

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anthony Realini, West Virginia University:
glaucoma
selective laser trabeculoplasty
clinical trial
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases