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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Ocular Hypertension; Primary Open-Angle Glaucoma, Unspecified Eye
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tahlequah, Oklahoma, United States, 74464
      • Northeastern State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Existing patients at primary eye care optometric facilities.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure via Goldmann tonometry	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.	6 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 21, 2019
• Primary Completion (ACTUAL): May 8, 2022
• Study Completion (ANTICIPATED): August 30, 2022

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (ACTUAL): July 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
• Other Study ID Numbers: NSUOCO0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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