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

• Conditions: Primary Open-Angle Glaucoma, Unspecified Eye; Ocular Hypertension

• Registration Number: NCT04036214
• Lead Sponsor: Northeastern State University

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-29
• Study Start: 2019-08-21
• Primary Completion: 2022-05-08
• Status Verified: 2022-08
• Study Completion: 2022-08-30
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Northeastern State University; 🇺🇸 Tahlequah, Oklahoma, United States