search
Back to results

Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment

Primary Purpose

Primary Open-angle Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Educational Intervention
Usual Care
Ophthalmologist Educational Intervention
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Primary Open-angle Glaucoma focused on measuring educational intervention, SLT, selective laser trabeculoplasty, POAG, eye drops, Primary Open Angle Glaucoma

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wills Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Other

Arm Label

Patient Educational Intervention group

Usual care group

Ophthalmologist Educational Intervention group

Arm Description

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

Patients receive standard of care.

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 27, 2017
Last Updated
January 28, 2020
Sponsor
Wills Eye
search

1. Study Identification

Unique Protocol Identification Number
NCT03365778
Brief Title
Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment
Official Title
An Educational Intervention to Increase Adoption of Selective Laser Trabeculoplasty as First-Line Treatment for Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma
Keywords
educational intervention, SLT, selective laser trabeculoplasty, POAG, eye drops, Primary Open Angle Glaucoma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Educational Intervention group
Arm Type
Active Comparator
Arm Description
Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure.
Arm Title
Usual care group
Arm Type
Placebo Comparator
Arm Description
Patients receive standard of care.
Arm Title
Ophthalmologist Educational Intervention group
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Patient Educational Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. No other guidance will be provided.
Intervention Type
Other
Intervention Name(s)
Ophthalmologist Educational Intervention
Other Intervention Name(s)
Ophthalmologists
Intervention Description
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.
Primary Outcome Measure Information:
Title
Completion of Selective Laser Trabeculoplasty (SLT)
Description
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.
Time Frame
1 hour
Title
Measure Educational Effects of Selective Laser Trabeculoplasty (SLT)
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Measure Educational Effects of Selective Laser Trabeculoplasty (SLT) Among Ophthalmologists
Description
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.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L. Jay Katz, MD
Organizational Affiliation
Wills Eye
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19120
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34041935
Citation
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.
Results Reference
derived

Learn more about this trial

Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment

We'll reach out to this number within 24 hrs