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Clarifying the Optimal Application of SLT Therapy Trial (COAST)

Primary Purpose

Glaucoma and Ocular Hypertension

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Low Energy SLT
Standard Energy SLT
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma and Ocular Hypertension focused on measuring glaucoma, selective laser trabeculoplasty, clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harvard Eye AssociatesRecruiting
  • Doheny Eye Center UCLARecruiting
  • University of California, DavisRecruiting
  • University of California, San FranciscoRecruiting
  • Mile High Eye InstituteRecruiting
  • Clear Vue Laser Eye CenterRecruiting
  • Northwestern Medical GroupRecruiting
  • Arbors Centers for Eye CareRecruiting
  • Illinois Eye CenterRecruiting
  • Wilmer Eye Institute Johns HopkinsRecruiting
  • Massachusetts Eye and EarRecruiting
  • Ophthalmic Consultants of BostonRecruiting
  • Mark Latina, LLCRecruiting
  • University of Michigan Kellogg Eye Center
  • Kresge Eye Institute Wayne State UniversityRecruiting
  • New York Eye Surgery AssociatesRecruiting
  • University Hospitals Eye InstituteRecruiting
  • Cleveland Clinic Cole Eye InstituteRecruiting
  • Devers Eye InstituteRecruiting
  • Eye Care Specialists
  • Scheie Eye InstituteRecruiting
  • Wills Eye HospitalRecruiting
  • UPMC Eye CenterRecruiting
  • Vanderbilt Eye InstituteRecruiting
  • Ophthalmology AssociatesRecruiting
  • Spokane Eye Clinical ResearchRecruiting
  • West Virginia UniversityRecruiting
  • University of Wisconsin-MadisonRecruiting
  • Ocular Health Centre
  • Moorfields Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

First Randomization: Low Energy SLT

First Randomization: Standard Energy SLT

Second Randomization: Annual Low Energy Repeat SLT

Second Randomization: As-Needed Repeat SLT at Initial Energy

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

12-month survival
Survival of first SLT through Month 12
48-month medication-free survival
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

Mean IOP
Mean IOP at month 12
Long-term mean IOP
Mean IOP at each study visit
Incidence of IOP spikes
IOP spikes > 5 mmHg on day of SLT

Full Information

First Posted
June 27, 2021
Last Updated
August 9, 2023
Sponsor
West Virginia University
Collaborators
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT04967989
Brief Title
Clarifying the Optimal Application of SLT Therapy Trial
Acronym
COAST
Official Title
Clarifying the Optimal Application of SLT Therapy Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
Collaborators
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma and Ocular Hypertension
Keywords
glaucoma, selective laser trabeculoplasty, clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
640 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
First Randomization: Low Energy SLT
Arm Type
Experimental
Arm Description
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.
Arm Title
First Randomization: Standard Energy SLT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Second Randomization: Annual Low Energy Repeat SLT
Arm Type
Experimental
Arm Description
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.
Arm Title
Second Randomization: As-Needed Repeat SLT at Initial Energy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Low Energy SLT
Intervention Description
SLT performed at low energy
Intervention Type
Procedure
Intervention Name(s)
Standard Energy SLT
Intervention Description
SLT performed at standard energy
Primary Outcome Measure Information:
Title
12-month survival
Description
Survival of first SLT through Month 12
Time Frame
12 months
Title
48-month medication-free survival
Description
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
Time Frame
48 months
Secondary Outcome Measure Information:
Title
Mean IOP
Description
Mean IOP at month 12
Time Frame
12 months
Title
Long-term mean IOP
Description
Mean IOP at each study visit
Time Frame
12, 24, 36, and 48 months
Title
Incidence of IOP spikes
Description
IOP spikes > 5 mmHg on day of SLT
Time Frame
0, 12, 24, 35, and 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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): 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] Mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation >-6.0 dB with no points in the central 5° <15 dB 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: Advanced POAG in either eye Glaucoma other than POAG (including pigmentary and pseudoexfoliation glaucoma) in either eye Mean IOP > 35 mmHg at either the screening or baseline visit in either eye Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye Contraindications to SLT, brimonidine, or any other study intervention Any corneal pathology that would preclude accurate assessment of IOP by Goldmann tonometry in either eye Any intraocular surgical procedure within the past 6 months in either eye Inability to attend all scheduled study visits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tony Realini, MD, MPH
Phone
3045986926
Email
hypotonywvu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Realini, MD, MPH
Organizational Affiliation
West Virginia University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Goundappa K Balasubramani, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Wisniewski, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard Eye Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmin Kaur
Phone
949-951-2020
Email
jkaur@harvardeye.com
First Name & Middle Initial & Last Name & Degree
Ye Elaine Wang, MD
Facility Name
Doheny Eye Center UCLA
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janett Mendez
Phone
626-817-4747
Email
JanettMendez@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Judy L Chen, MD
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Garcia
Phone
916-734-4546
Email
smgarcia@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
James Brandt, MD
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mari Costantini
Phone
510-646-2065
Email
mari.costantini@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Ying Han, MD
Facility Name
Mile High Eye Institute
City
Sheridan
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Ortiz
Phone
303-482-1300
Ext
106
Email
research@mhei.com
First Name & Middle Initial & Last Name & Degree
Zachary Vest, MD
Facility Name
Clear Vue Laser Eye Center
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Hill
Phone
561-432-4141
Email
michelle@clearvuenow.com
First Name & Middle Initial & Last Name & Degree
Monique Barbour, MD
Facility Name
Northwestern Medical Group
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60615
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ethan Miller
Phone
312-695-0252
Email
ethan.miller@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Angelo Tanna, MD
Facility Name
Arbors Centers for Eye Care
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorene Rafol
Phone
708-249-1026
Email
lorenerafol@arboreyecare.com
First Name & Middle Initial & Last Name & Degree
Richard Quinones, MD
Facility Name
Illinois Eye Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Hendershott
Phone
309-213-0664
Email
lhendershott@illinoiseyecenter.com
First Name & Middle Initial & Last Name & Degree
Sachin Kalarn, MD
Facility Name
Wilmer Eye Institute Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ala Lutsenko
Phone
818-744-8788
First Name & Middle Initial & Last Name & Degree
Pradeep Ramulu, MD
Facility Name
Massachusetts Eye and Ear
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Succar
Email
Tony_Succar@MEEI.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Michael Lin, MD
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Lu
Phone
617-314-2687
Email
jlu@eyeboston.com
First Name & Middle Initial & Last Name & Degree
Theodor Sauer, MD
Facility Name
Mark Latina, LLC
City
Reading
State/Province
Massachusetts
ZIP/Postal Code
01867
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Gardikas
Phone
781-942-9876
Email
anngardikas76@gmail.com
First Name & Middle Initial & Last Name & Degree
Mark Latina, MD
Facility Name
University of Michigan Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Rudberg
Phone
734-647-9196
Email
rulindsa@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Amanda Bicket, MD
Facility Name
Kresge Eye Institute Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bayan El-Haik
Phone
313-515-5487
Email
bayan.el-haik@wayne.edu
First Name & Middle Initial & Last Name & Degree
Bret Hughes, MD
Facility Name
New York Eye Surgery Associates
City
Bronx
State/Province
New York
ZIP/Postal Code
10469
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krystina Tavarez-Feliciano
Phone
347-860-4474
Email
kfeliciano@nyeye.com
First Name & Middle Initial & Last Name & Degree
Nathan Radcliffe, MD
Facility Name
University Hospitals Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rashad Spruill
Phone
216-844-7934
Email
rashad.spruill@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Douglas Rhee, MD
Facility Name
Cleveland Clinic Cole Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Cidor
Phone
216-445-5248
Email
cidorm@ccf.org
First Name & Middle Initial & Last Name & Degree
Ang Li, MD
Facility Name
Devers Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack Rees
Phone
503-413-8495
Email
jrees@deverseye.org
First Name & Middle Initial & Last Name & Degree
Robert Kinast, MD
Facility Name
Eye Care Specialists
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patty Yuhas
Phone
570-714-5901
Email
patty.yuhas@vipeyes.com
First Name & Middle Initial & Last Name & Degree
Daniel Lutz, MD
Facility Name
Scheie Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Criston Young
Phone
856-519-8295
Email
Criston.Young@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Ahmara Ross, MD
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maskerem Divers
Phone
215-825-4712
Email
MDivers@willseye.org
First Name & Middle Initial & Last Name & Degree
Daniel Lee, MD
Facility Name
UPMC Eye Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rhonda Dahlstrom
Phone
412-647-3434
Email
dahlstromrj@upmc.edu
First Name & Middle Initial & Last Name & Degree
Ian Conner, MD
Facility Name
Vanderbilt Eye Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marybeth Carter
Phone
616-936-1639
Email
marybeth.l.carter@vumc.org
First Name & Middle Initial & Last Name & Degree
Rachel Kuchtey, MD
Facility Name
Ophthalmology Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Rosado
Phone
817-332-2020
Ext
1780
Email
jrosado@oafw2020.com
First Name & Middle Initial & Last Name & Degree
Brian Flowers, MD
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dylan Waidelich
Phone
509-623-9768
Email
dwaidelich@spokaneeye.com
First Name & Middle Initial & Last Name & Degree
Rory Allar, MD
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athena Echols, LPN
Phone
304-598-6977
Email
athena.sparks@wvumedicine.org
First Name & Middle Initial & Last Name & Degree
Tony Realini, MD, MPH
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Boyd
Phone
608-265-4589
Email
kmboyd@wisc.edu
First Name & Middle Initial & Last Name & Degree
Yao Liu, MD
Facility Name
Ocular Health Centre
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2A0K5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nirmit Shah
Phone
519-496-7537
Email
nirmits378@gmail.com
First Name & Middle Initial & Last Name & Degree
Toby Chan, MD
Facility Name
Moorfields Eye Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hayley Boston
Phone
020-7566-2117
Email
h.boston@nhs.net
First Name & Middle Initial & Last Name & Degree
Gus Gazzard, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
At study completion
IPD Sharing Access Criteria
See above
Citations:
PubMed Identifier
33428350
Citation
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.
Results Reference
background
Links:
URL
http://www.COASTtrial.org
Description
Study website

Learn more about this trial

Clarifying the Optimal Application of SLT Therapy Trial

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