Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment
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|ClinicalTrials.gov Identifier: NCT03365778|
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : December 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Patient Education||Other: Educational intervention Other: Usual care||Not Applicable|
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 IOP, prevent disease progression, preserve vision and prevent blindness. However, many people with glaucoma do not always use their medication, 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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.|
|Masking:||None (Open Label)|
|Official Title:||An Educational Intervention to Increase Adoption of Selective Laser Trabeculoplasty as First-Line Treatment for Glaucoma|
|Actual Study Start Date :||October 23, 2017|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||October 1, 2018|
Active Comparator: Educational intervention group
Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure.
Other: 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.
- Educational Intervention for selective laser trabeculoplasty (SLT) versus Medication to lower eye pressure. [ Time Frame: 6 months ]Rates of SLT will be tracked in both groups. Follow-up eye exam appointments will be tracked for a 6-month period to assess number of patients who elect SLT. Rate of SLT will be compared between SLT Educational Intervention and Usual Care groups at these time periods.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365778
|Contact: Judie Tran, BSN||215-928-3221||Jtran@willseye.org|
|Contact: MaryJo Schwartz||215-928-3123|
|United States, Pennsylvania|
|Wills Eye Hospital||Recruiting|
|Philadelphia, Pennsylvania, United States, 19120|
|Contact: Judie Tran|
|Principal Investigator:||L. Jay Katz, MD||Wills Eye|