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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual care group | Placebo Comparator | Patients receive standard of 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| L. Jay Katz, MD | Wills Eye | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19120 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34041935 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Educational Intervention Group | 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. |
| FG001 | Usual Care Group | 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. |
| FG002 | Ophthalmologist Educational Intervention Group | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Ophthalmologists were sent selective laser trabeculoplasty (SLT) educational information and online survey access only. They did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Educational Intervention Group | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 1 hour |
|
1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Educational Intervention Group | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Wills Eye Hospital | 215-928-3213 | jtran@willseye.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2017 | Jun 17, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form for Patients | Jun 15, 2017 | Jun 17, 2019 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form for Ophthalmologists | Jul 11, 2017 | Jun 17, 2019 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000072163 | Ophthalmologists |
| ID | Term |
|---|---|
| D010820 | Physicians |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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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.
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|
| 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. |
|
| 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. |
|
|
| 30 minutes |
| BG001 | Usual Care Group | 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. |
| BG002 | Ophthalmologist Educational Intervention Group | 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. |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Ophthalmologists did not provide personal information such as date of birth, gender, ethnicity, race. Baseline characteristics in this group only include number of general ophthalmologists, ophthalmology residents and glaucoma specialists. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of Ophthalmologist | Ophthalmologists participated in SLT educational presentation and online survey. Baseline characteristics collected from this group only include type of ophthalmologist. Age, gender, ethnicity and race were not captured. | Patient Educational Intervention and Usual Care Groups are not compared in Type of Ophthalmologist baseline data. | Count of Participants | Participants |
|
| OG001 | Usual Care Group | 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. |
|
|
| 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. | Usual Care group not included since they did not receive education intervention. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 30 minutes |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Usual Care Group | 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. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Ophthalmologist Educational Intervention Group | 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). | 0 | 53 | 0 | 53 | 0 | 53 |
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| >=65 years |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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|---|---|
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