Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment

NCT ID: NCT03365778

Last Updated: 2020-01-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Open-angle Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient Educational Intervention group

Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure.

Group Type ACTIVE_COMPARATOR

Patient Educational Intervention

Intervention Type 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.

Usual care group

Patients receive standard of care.

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type 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 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).

Group Type OTHER

Ophthalmologist Educational Intervention

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ophthalmologists

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wills Eye

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

L. Jay Katz MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

L. Jay Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34041935 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Informed Consent Form for Patients

View Document

Document Type: Informed Consent Form: Informed Consent Form for Ophthalmologists

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB # 17-641E

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.