Clinical Trials Logo

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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date August 25, 2021
Est. primary completion date August 25, 2021
Accepts healthy volunteers
Gender All
Age group 21 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
monitoring of adherence with medication
persons taking routine postoperative eye drops will have their frequency of drop taking monitored

Locations

Country Name City State
United States Johns Hopkins University Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary adherence rate frequency of taking eye drops 6 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT06000865 - Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE N/A
Recruiting NCT06278597 - Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device N/A
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03274024 - The Asia Primary Tube Versus Trab (TVT) Study N/A
Completed NCT04552964 - Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma N/A
Recruiting NCT01957267 - Functional and Structural Imaging for Glaucoma
Active, not recruiting NCT04624698 - iStent Inject New Enrollment Post-Approval Study N/A
Completed NCT04020705 - The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma N/A
Completed NCT03150160 - Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma Phase 4
Not yet recruiting NCT05581498 - Glaucoma Exercise as Medicine Study (GEMS). N/A
Recruiting NCT02921568 - Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes N/A
Active, not recruiting NCT02901730 - Clinical Study of LPI With Different Laser Wavelengths N/A
Completed NCT02955849 - A Trial of China Laser and Surgery Study Glaucoma in Rural China Early Phase 1
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Recruiting NCT02554214 - Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device N/A
Active, not recruiting NCT02390284 - Stop Retinal Ganglion Cell Dysfunction Study Phase 3
Completed NCT02520674 - Glaucoma Screening With Smartphone Ophthalmology N/A
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT02246764 - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02653963 - Triamcinolone for Ahmed Glaucoma Valve N/A