Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03402802 |
| Other study ID # |
IRB00160532 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2019 |
| Est. completion date |
August 25, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
