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

Sponsor
Northeastern State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04036214
Collaborator
(none)
200
1
32.6
6.1

Study Details

Study Description

Brief Summary

To measure the efficacy and safety outcomes of SLT performed by optometrists.

Condition or Disease Intervention/Treatment Phase
  • 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

Study Type:
Observational
Anticipated 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 :
Aug 21, 2019
Anticipated Primary Completion Date :
May 8, 2022
Anticipated Study Completion Date :
May 8, 2022

Outcome Measures

Primary Outcome Measures

  1. Intraocular Pressure via Goldmann tonometry [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Northeastern State University Tahlequah Oklahoma United States 74464

Sponsors and Collaborators

  • Northeastern State University

Investigators

  • Principal Investigator: Nate Lighthizer, OD, Northeastern State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Northeastern State University
ClinicalTrials.gov Identifier:
NCT04036214
Other Study ID Numbers:
  • NSUOCO0001
First Posted:
Jul 29, 2019
Last Update Posted:
Sep 9, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 9, 2021