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

NCT04036214 | Unknown FDA Device

• 1 other identifier: NSUOCO0001
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Open-Angle Glaucoma, Unspecified Eye; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Selective Laser Trabeculoplasty DEVICE

Selective Laser Trabeculoplasty Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Existing patients at primary eye care optometric facilities.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northeastern State University: lead

Study Sites (1)

Northeastern State University

Tahlequah, Oklahoma, 74464, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Nate Lighthizer, OD

  Northeastern State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 29, 2019
• Study Start: August 21, 2019
• Primary Completion: May 8, 2022
• Study Completion: August 30, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)