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CompletedNCT03402802Updated Aug 27, 2021

Steroid Eyedrop Adherence After Trabeculectomy

An observational study in Glaucoma and Adherence, Patient, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 21 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-08-27.

Sponsored by Johns Hopkins University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
92
Ages
21 Years to 100 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Glaucoma
  • Adherence, Patient

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Keywords

  • eye drop
03

Who can participate

Ages eligible
21 Years to 100 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

adult glaucoma patients

Inclusion criteria

  • Persons having glaucoma surgery

Exclusion criteria

Exclusion Criteria:

  • Persons not eligible for glaucoma surgery, including pregnant females persons allergic to standard postoperative eye drops
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
92 participants (actual)
Patient registry
No

Interventions

  • Drugmonitoring of adherence with medication

    persons taking routine postoperative eye drops will have their frequency of drop taking monitored

05

What researchers measure

Primary outcomes

  1. adherence rate

    frequency of taking eye drops

    Time frame: 6 weeks

06

Study locations

1 site
  • Johns Hopkins University
    Baltimore, Maryland 21287, United States
07

References and documents

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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03402802
Lead sponsor
Johns Hopkins University
Responsible party
Sponsor
First posted
Jan 18, 2018
Start date
Sep 1, 2019
Primary completion
Aug 25, 2021
Completion
Aug 25, 2021
Last update
Aug 27, 2021

Study contacts

Harry A Quigley, MD
principal investigator · Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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