Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment

• Sponsor: Wills Eye (Other)
• Overall Status: Completed
• CT.gov ID: NCT03365778
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Arms: 3
• Actual Duration (Months): 26.3
• Patients Per Site Per Month: 3.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open-angle Glaucoma	Other: Patient Educational Intervention; Other: Usual Care; Other: Ophthalmologist Educational Intervention	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Other
• Official Title: An Educational Intervention to Increase Adoption of Selective Laser Trabeculoplasty as First-Line Treatment for Glaucoma
• Actual Study Start Date: Oct 23, 2017
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patient Educational Intervention group Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure.	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.
Placebo Comparator: Usual care group Patients receive standard of care.	Other: 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.
Other: Ophthalmologist Educational Intervention group 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; 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.; Other Names: Ophthalmologists

Outcome Measures

Primary Outcome Measures

1. Completion of Selective Laser Trabeculoplasty (SLT) [1 hour]

   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.

2. Measure Educational Effects of Selective Laser Trabeculoplasty (SLT) [1 hour]

   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

1. Measure Educational Effects of Selective Laser Trabeculoplasty (SLT) Among Ophthalmologists [30 minutes]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wills Eye Hospital	Philadelphia	Pennsylvania	United States	19120

Sponsors and Collaborators

• Wills Eye

Investigators

• Principal Investigator: L. Jay Katz, MD, Wills Eye

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 1, 2017
• Informed Consent Form: Informed Consent Form for Patients - Jun 15, 2017
• Informed Consent Form: Informed Consent Form for Ophthalmologists - Jul 11, 2017

More Information

Publications

None provided.

• Responsible Party: L. Jay Katz MD, Principal Investigator, Wills Eye
• ClinicalTrials.gov Identifier: NCT03365778
• Other Study ID Numbers: IRB # 17-641E
• First Posted: Dec 7, 2017
• Last Update Posted: Jan 30, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by L. Jay Katz MD, Principal Investigator, Wills Eye: educational intervention; SLT; selective laser trabeculoplasty; POAG; eye drops; Primary Open Angle Glaucoma
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle

Study Results

Participant Flow

Arm/Group Title	Patient Educational Intervention Group	Usual Care Group	Ophthalmologist Educational Intervention Group
Arm/Group Description	Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure. 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.	Patients receive standard of care. 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.	General ophthalmologists, ophthalmology residents, and glaucoma specialists in the Wills Eye Hospital physician contact database received an online survey and educational slide presentation regarding selective laser trabeculoplasty (SLT).
Period Title: Overall Study
STARTED	16	17	53
COMPLETED	16	17	53
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Patient Educational Intervention Group	Usual Care Group	Ophthalmologist Educational Intervention Group	Total
Arm/Group Description	Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure. 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.	Patients receive standard of care. 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.	General ophthalmologists, ophthalmology residents, and glaucoma specialists in the Wills Eye Hospital physician contact database received online survey and educational slide presentation regarding selective laser trabeculoplasty (SLT). No other personal information i.e. age, gender, ethnicity, race was provided by these participants.	Total of all reporting groups
Overall Participants	16	17	53	86
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 50%	8 47.1%	16 30.2%
>=65 years	8 50%	9 52.9%	17 32.1%
Sex: Female, Male (Count of Participants)
Female	8 50%	7 41.2%	15 28.3%
Male	8 50%	10 58.8%	18 34%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 6.3%	1 5.9%	0 0%	2 2.3%
Not Hispanic or Latino	9 56.3%	14 82.4%	0 0%	23 26.7%
Unknown or Not Reported	6 37.5%	2 11.8%	53 100%	61 70.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	1 6.3%	0 0%	0 0%	1 1.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	5 31.3%	13 76.5%	0 0%	18 20.9%
White	5 31.3%	2 11.8%	0 0%	7 8.1%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	5 31.3%	2 11.8%	53 100%	60 69.8%
Region of Enrollment (participants) [Number]
United States	16 100%	17 100%	53 100%	86 100%
Type of Ophthalmologist (Count of Participants)
General ophthalmologists	0 0%	0 0%	26 49.1%	26 30.2%
Ophthalmology Residents	0 0%	0 0%	5 9.4%	5 5.8%
Glaucoma Specialists	0 0%	0 0%	22 41.5%	22 25.6%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Educational Intervention Group	Usual Care Group
Arm/Group Description	Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure. 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.	Patients receive standard of care. 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.
Measure Participants	16	17
Count of Participants [Participants]	10 62.5%	6 35.3%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Usual Care group not included since they did not receive education intervention.

Arm/Group Title	Educational Intervention Group	Usual Care Group
Arm/Group Description	Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure. 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.	Patients receive standard of care. 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.
Measure Participants	16	0
Pre-Intervention Yes	0 0%	0 0%
Post-Intervention Yes	12 75%	0 0%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ophthalmologist Educational Intervention Group
Arm/Group 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). 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.
Measure Participants	53
Count of Participants [Participants]	45 281.3%

Adverse Events

Time Frame	1 hour
Arm/Group Title	Patient Educational Intervention Group		Usual Care Group		Ophthalmologist Educational Intervention Group
Arm/Group Description	Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure. 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.		Patients receive standard of care and will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. No other guidance will be provided.		General ophthalmologists, ophthalmology residents, and glaucoma specialists in the Wills Eye Hospital physician contact database received an online survey and educational slide presentation regarding selective laser trabeculoplasty (SLT).
All Cause Mortality
	Patient Educational Intervention Group		Usual Care Group		Ophthalmologist Educational Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)		0/53 (0%)
Serious Adverse Events
	Patient Educational Intervention Group		Usual Care Group		Ophthalmologist Educational Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)		0/53 (0%)
Other (Not Including Serious) Adverse Events
	Patient Educational Intervention Group		Usual Care Group		Ophthalmologist Educational Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)		0/53 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.