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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
Sponsor:
Information provided by (Responsible Party):
L. Jay Katz MD, Wills Eye

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 glaucoma treatment to consider before the use of glaucoma eye drops.

Condition or disease Intervention/treatment Phase
Patient Education Other: Educational intervention Other: Usual care Not Applicable

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 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
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.
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 : October 23, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Judie Tran, BSN 215-928-3221 Jtran@willseye.org
Contact: MaryJo Schwartz 215-928-3123

Locations
United States, Pennsylvania
Wills Eye Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19120
Contact: Judie Tran         
Sponsors and Collaborators
Wills Eye
Investigators
Principal Investigator: L. Jay Katz, MD Wills Eye

Responsible Party: L. Jay Katz MD, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT03365778     History of Changes
Other Study ID Numbers: IRB # 17-641E
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
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, Wills Eye:
educational intervention
SLT
selective laser trabeculoplasty

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases