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

Ocular Hypertension Clinical Trial

— SLT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04036214
• Other study ID #: NSUOCO0001
• Status: Active, not recruiting
• Start date: August 21, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: August 2022
• Source: Northeastern State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: August 30, 2022
• Est. primary completion date: May 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension
• Primary Open-Angle Glaucoma, Unspecified Eye

Intervention

Device:
• Selective Laser Trabeculoplasty
Selective Laser Trabeculoplasty Laser

Locations

Country	Name	City	State
United States	Northeastern State University	Tahlequah	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Northeastern State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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