- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03402802
Steroid Eyedrop Adherence After Trabeculectomy
August 26, 2021 updated by: Johns Hopkins University
The study will monitor how often persons use eye drops that are prescribed after glaucoma surgery and will compare the adherence with drop use to the success rate of the surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Trabeculectomy is the most common operation performed for all forms of glaucoma.
The procedure depends upon appropriately modulated healing of the conjunctiva and sclera, a major component of which is delivery of frequent topical corticosteroid eye drops (prednisolone acetate 1%) by the patient, initially every 2 hours when awake for 1-2 weeks, then in tapering frequency over the 6 weeks after surgery.
While the initial success of trabeculectomy at one year varies from 55-80% depending upon the criteria chosen to measure outcome, improvements in success would benefit hundreds of thousands of patients in the USA yearly.
There is reasonable evidence that steroid drops benefit success, but there is essentially no data on how successfully patients remember to take the drops.
In previous research, investigators have shown that glaucoma patients take only half to two-thirds of prescribed drops.
An electronic monitoring device is now available that can fit the eye drop bottle used in steroid drops, accurately measuring the time and date of each drop taken.
The investigators can further assess the accuracy with which each patient can deliver a drop from the bottle being monitored in a clinic session directly onto the eye's surface by observing their performance.
The proposal's hypothesis is that the one year success rate of the procedure will be related to the adherence to steroid drop taking by patients.
The outcome will have two important benefits.
First, if adherence is less than ideal (which is very likely), then those with greater adherence will have more successful surgery, confirming that steroid treatment is effective.
This has only been measured once, 30 years ago, at a time when trabeculectomy was being performed quite differently.
If steroid treatment is not related to success, a change in preferred practice patterns is in order.
If steroid treatment is related to success and adherence is variable, the investigation will have proven means to increase adherence through reminder systems, which have shown in past randomized clinical trial to be effective.
Study Type
Observational
Enrollment (Actual)
92
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
adult glaucoma patients
Description
Inclusion Criteria:
- Persons having glaucoma surgery
Exclusion Criteria:
- Persons not eligible for glaucoma surgery, including pregnant females persons allergic to standard postoperative eye drops
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adherence rate
Time Frame: 6 weeks
|
frequency of taking eye drops
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2019
Primary Completion (ACTUAL)
August 25, 2021
Study Completion (ACTUAL)
August 25, 2021
Study Registration Dates
First Submitted
December 19, 2017
First Submitted That Met QC Criteria
January 17, 2018
First Posted (ACTUAL)
January 18, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 27, 2021
Last Update Submitted That Met QC Criteria
August 26, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00160532
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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