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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):

November 27, 2017
December 7, 2017
December 21, 2017
October 23, 2017
June 30, 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03365778 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment
An Educational Intervention to Increase Adoption of Selective Laser Trabeculoplasty as First-Line Treatment for Glaucoma
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.

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.

Interventional
Not Provided
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
Patient Education
  • 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.
  • 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.
  • Active Comparator: Educational intervention group
    Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure.
    Intervention: Other: Educational intervention
  • Placebo Comparator: Usual care group
    Patients receive standard of care.
    Intervention: Other: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
October 1, 2018
June 30, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 90 Years   (Adult, Senior)
No
Contact: Judie Tran, BSN 215-928-3221 Jtran@willseye.org
Contact: MaryJo Schwartz 215-928-3123
United States
 
 
NCT03365778
IRB # 17-641E
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
L. Jay Katz MD, Wills Eye
Wills Eye
Not Provided
Principal Investigator: L. Jay Katz, MD Wills Eye
Wills Eye
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP