Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment

Primary Open-angle Glaucoma Clinical Trial

Official title:

An Educational Intervention to Increase Adoption of Selective Laser Trabeculoplasty as First-Line Treatment for Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03365778
• Other study ID #: IRB # 17-641E
• Status: Completed
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Glaucoma is a disease characterized by optic nerve damage, visual field defects, elevated intraocular pressure (IOP) and progressive vision loss. More than 3 million Americans have glaucoma and more than 150,000 are blind as a result.

Regular use of glaucoma medications can usually lower intraocular pressure (IOP), prevent disease progression, preserve vision and prevent blindness. However, many people with glaucoma do not always use their medication as directed, with about one-third to one-half of patients with glaucoma not taking their drops as often as necessary, or have difficulty putting in the drops. There are also numerous local side effects from using glaucoma eye drops including red eyes, blurry vision and dry eye symptoms. Systemic side effects from eye drops range from triggering asthma, to lethargy and depression.

Selective laser trabeculoplasty (SLT) has been used safely and effectively for the treatment of elevated IOP in patients with open angle glaucoma for more than 20 years. SLT may result in mild and temporary IOP elevation, but this is a small risk and rarely significant. Other side effects include blurred vison and inflammation of the cornea (front, clear part of the eye), but they are extremely rare.

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 considered as first glaucoma treatment before the use of glaucoma eye drops.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 31, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• previous laser trabeculoplasty

• previous glaucoma surgery

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

Intervention

Other:
• Patient Educational Intervention
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.
• Usual Care
Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. No other guidance will be provided.
• Ophthalmologist Educational Intervention
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.

Locations

Country	Name	City	State
United States	Wills Eye Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Measure Educational Effects of Selective Laser Trabeculoplasty (SLT) Among Ophthalmologists	To evaluate barriers for widespread adoption of selective laser trabeculoplasty (SLT) as first line treatment of high eye pressure, we assessed the beliefs and attitudes of ophthalmologists regarding SLT. An educational slide presentation and survey targeted physicians to increase awareness and consideration of SLT earlier in the glaucoma treatment paradigm. Number of respondents who currently offer laser treatment for newly diagnosed glaucoma patients.	30 minutes