Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment

NCT03365778 | Completed Results

• 1 other identifier: IRB # 17-641E
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop an educational program that will help improve the patients' understanding of what laser treatment is, how it might be beneficial to them, and why it should be the first eye pressure lowering glaucoma treatment to consider before the use of glaucoma eye drops.

Conditions

Primary Open-angle Glaucoma

Keywords

educational intervention; SLT; selective laser trabeculoplasty; POAG; eye drops; Primary Open Angle Glaucoma

Outcome Measures

Primary Outcomes (2)

• Completion of Selective Laser Trabeculoplasty (SLT)

  Percentage of patients who elect the Selective Laser Trabeculoplasty (SLT), as treatment for lowering eye pressure, compared between a group receiving SLT Educational Intervention and a Usual Care group. Follow-up eye examinations will be screened for a 6-month period to assess number of completed SLTs.

  1 hour

• Measure Educational Effects of Selective Laser Trabeculoplasty (SLT)

  Attitudes were assessed in the Patient Educational Intervention group before and immediately following intervention to determine how receptive they were regarding Selective Laser Trabeculoplasty (SLT) as a therapy to lowering eye pressure as compared to the more common therapy of daily eye drops.

  1 hour

Secondary Outcomes (1)

• Measure Educational Effects of Selective Laser Trabeculoplasty (SLT) Among Ophthalmologists

  30 minutes

Study Arms (3)

Patient Educational Intervention group

ACTIVE COMPARATOR

Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure.

Other: Patient Educational Intervention

Usual care group

PLACEBO COMPARATOR

Patients receive standard of care.

Other: Usual Care

Ophthalmologist Educational Intervention group

OTHER

General ophthalmologists, ophthalmology residents, and glaucoma specialists in the Wills Eye Hospital physician contact database receive online survey and educational slide presentation regarding selective laser trabeculoplasty (SLT).

Other: Ophthalmologist Educational Intervention

Interventions

Patient Educational Intervention OTHER

Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. Then they will receive educational materials including 20 printed slides and view a 3 minute video on safety and efficacy of SLT. If patients agree to SLT, assistance in scheduling will be provided.

Patient Educational Intervention group

Usual Care OTHER

Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. No other guidance will be provided.

Usual care group

Ophthalmologist Educational Intervention OTHER

Responses to online survey regarding beliefs and attitudes towards selective laser trabeculoplasty (SLT) before and after educational slide presentation were recorded and compared between physician specialty groups.

Also known as: Ophthalmologists

Ophthalmologist Educational Intervention group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients between 40 and 90 years of age
• high-risk ocular hypertension, primary open-angle glaucoma, or pseudo-exfoliation glaucoma
• currently treated with at least one glaucoma eye drop with stable intraocular pressure

You may not qualify if:

• previous laser trabeculoplasty
• previous glaucoma surgery

Sponsors & Collaborators

• Wills Eye: lead

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19120, United States

Location

Related Publications (1)

• Tran E, Sanvicente C, Hark LA, Myers JS, Zhang Q, Shiuey EJ, Tran J, Bonafede L, Hamershock RA, Withers C, Katz LJ. Educational intervention to adopt selective laser trabeculoplasty as first-line glaucoma treatment: Randomized controlled trial: Educational intervention on selective laser trabeculoplasty. Eur J Ophthalmol. 2022 May;32(3):1538-1546. doi: 10.1177/11206721211018365. Epub 2021 May 27.

  PMID: 34041935 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Ophthalmologists

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services

Limitations and Caveats

Questionnaires limited determining how much attitudes changed immediately following education. Small sample size limited ability to show significant differences. Location created difficulty in finding patients that fit inclusion criteria.

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: Wills Eye Hospital

jtran@willseye.org

215-928-3213

Study Officials

• L. Jay Katz, MD

  Wills Eye

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Selective Laser Trabeculoplasty (SLT) Educational Intervention group (n=20) or Usual Care group (n=20). Knowledge, beliefs, barriers, and attitudes about SLT vs. medication as first line treatment of glaucoma will be assessed in both groups. To evaluate barriers for widespread adoption of this procedure, we assessed beliefs and attitudes of ophthalmologists regarding SLT. We developed an educational slide presentation targeted at physicians to increase consideration of SLT earlier in glaucoma treatment paradigm.

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 7, 2017
• Study Start: October 23, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 31, 2019
• Last Updated: January 30, 2020
• Results First Posted: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)