GlaucomaNCT03402802
Steroid Eyedrop Adherence After Trabeculectomy
An observational study of Glaucoma and Adherence, Patient, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Glaucoma, Adherence, Patient
- What is being tested?
- monitoring of adherence with medication
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 25 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- Adult, Older adult
Study population: adult glaucoma patients
Who may be able to join
- Persons having glaucoma surgery
Who cannot join
- Persons not eligible for glaucoma surgery, including pregnant females persons allergic to standard postoperative eye drops
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Glaucoma, Adherence, Patient
- Being tested
- monitoring of adherence with medication
- Keywords
- eye drop
- Medical subject headings
- Glaucoma, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitoring of adherence with medicationDrug
persons taking routine postoperative eye drops will have their frequency of drop taking monitored
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence rate
frequency of taking eye drops
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Sep 2019
- Primary completion25 Aug 2021
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry A Quigley, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402802
- Sponsor's protocol ID
- IRB00160532
- Status last verified
- Aug 2021
- First submitted
- 19 Dec 2017
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McGlumphy EJ, Dosto NO, Johnson TV, Quigley HA. Electronically Monitored Corticosteroid Eye Drop Adherence after Trabeculectomy Compared to Surgical Success. Ophthalmol Glaucoma. 2022 Jul-Aug;5(4):379-387. doi: 10.1016/j.ogla.2021.12.007. Epub 2022 Jan 4.
PubMed 34995818
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroid Eyedrop Adherence After Trabeculectomy
- ClinicalTrials.gov ID
- NCT03402802
- Acronym / sponsor ID
- IRB00160532
- Conditions
- Glaucoma, Adherence, Patient
- Keywords
- eye drop
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult glaucoma patients
Key inclusion criteria (1 listed)
- Persons having glaucoma surgery
Key exclusion criteria (1 listed)
- Persons not eligible for glaucoma surgery, including pregnant females persons allergic to standard postoperative eye drops
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| monitoring of adherence with medicationpersons taking routine postoperative eye drops will have their frequency of drop taking monitored | Drug | – |
Primary outcome
adherence rate
Time frame: 6 weeks
frequency of taking eye drops
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Derived from this study: PubMed 34995818McGlumphy EJ, Dosto NO, Johnson TV, Quigley HA. Electronically Monitored Corticosteroid Eye Drop Adherence after Trabeculectomy Compared to Surgical Success. Ophthalmol Glaucoma. 2022 Jul-Aug;5(4):379-387. doi: 10.1016/j.ogla.2021.12.007. Epub 2022 Jan 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry A Quigley, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Adherence, Patient, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03402802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021; AzTrials last refreshed its copy on 31 Oct 2026.