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Efficacy and Safety Outcomes of Optometrist Performed Selective Laser Trabeculoplasty (SLT) (SLT)

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ClinicalTrials.gov Identifier: NCT04036214
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Northeastern State University

Study Description
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Brief Summary:
To measure the efficacy and safety outcomes of SLT performed by optometrists.

Condition or disease Intervention/treatment
Primary Open-Angle Glaucoma, Unspecified Eye Ocular Hypertension Device: Selective Laser Trabeculoplasty

Detailed Description:
Participants will undergo a pre-procedure examination in order to record baseline findings and to determine if they meet the inclusion criteria in order to undergo the procedure. Participants will undergo the SLT procedure and will be examined at 1 hour, 1 week and 6 weeks. Follow up examinations will evaluate eye pressure reduction and post-procedure complications. The rate complication post-procedure are typically low.

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Selective Laser Trabeculoplasty (SLT): Efficacy and Safety Outcomes of Optometrist (OD) Performed SLT
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

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Groups and Cohorts
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Intervention Details:
  • Device: Selective Laser Trabeculoplasty
    Selective Laser Trabeculoplasty Laser

Outcome Measures
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Primary Outcome Measures :
  1. Intraocular Pressure via Goldmann tonometry [ Time Frame: 6 weeks ]
    Pre and Post Procedure Intraocular Pressure will be measured using a Goldmann tonometer and will be measured in millimeters of Mercury (mmHg). Percent change in intraocular pressure will be determined.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Existing patients at primary eye care optometric facilities.
Criteria

Inclusion Criteria:

  1. Ability to provide written informed consent;
  2. At least 18 years of age, male or female, of Native American or Alaskan Native descent;
  3. Diagnosed with primary open angle glaucoma or ocular hypertension;
  4. Documented intraocular pressure greater than or equal to 23 mmHg;
  5. No prior glaucoma treatment unless treated with one topical drop.

Exclusion Criteria:

  1. History of trauma or ocular surgery within the last 6 months;
  2. History of corneal dystrophy;
  3. Current use of topical or systemic steroids;
  4. Advanced or severe glaucomatous findings based on comprehensive examination;
  5. Diagnosed with other types of glaucoma such as pseudoexfoliation syndrome, pigmentary glaucoma, normal tension glaucoma, and other additional glaucoma subtypes.
Contacts and Locations
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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): NCT04036214


Contacts
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Contact: Jeff M Miller, OD 918-444-4000 millerjm@nsuok.edu
Contact: Nate Lighthizer, OD 918-444-4000 lighthiz@nsuok.edu

Locations
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United States, Oklahoma
Northeastern State University Recruiting
Tahlequah, Oklahoma, United States, 74464
Contact: Jeff M Miller, OD    918-444-4000    millerjm@nsuok.edu   
Contact: Nate Lighthizer, OD    918-444-4000    lighthiz@nsuok.edu   
Sponsors and Collaborators
Northeastern State University
More Information
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Responsible Party: Northeastern State University
ClinicalTrials.gov Identifier: NCT04036214     History of Changes
Other Study ID Numbers: NSUOCO0001
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases