Cataract
Conditions
Brief summary
To monitor intraocular pressure in glaucoma patients after cataract surgery preformed in conjunction with minimally invasive glaucoma surgery (MIGS)
Detailed description
The purpose of this study is to monitor glaucoma patients intraocular pressure (IOP) after cataract surgery performed in conjunction with minimally invasive glaucoma surgery. After qualifying for this study, subjects will be randomized in a 1:1 allocation of one of two arms. The purpose of this study is to determine if Dextenza (dexamethasone) 0.4mg intracanalicular insert delivery system, provides a decreased risk of elevated post-operative IOP vs. standard therapy controlled topical steroid Durezol (Difluprednate ophthalmic emulsion) 0.05%
Interventions
intracanalicular insert delivery system
DRUGDurezol 0.05% Ophthalmic Emulsion
Standard therapy, topical steroid drop
Sponsors
Ocular Therapeutix, Inc.
Cathleen McCabe MD
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label prospective randomized comparative investigator -initiated study
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 or Older * Mild-to-moderate primary open angle glaucoma and visually significant cataract with plans to undergo clear cornea cataract surgery with Phacoemulsification and implantation of posterior chamber IOL combined with minimally invasive glaucoma surgery ( MIGS) procedure in both eyes.
Exclusion criteria
* Use of Topical steroid, systemic steroid or intravitreal steroid implants within last 3 months * Previous Corneal surgery or pathology * Active or history of chronic or recurrent inflammatory eye disease in either eye * Ocular Pain in either eye * Proliferative diabetic retinopathy in either eye * Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye. * Laser or incisional ocular surgery during the study period and 6 months prior in either eye * Systemic concomitant pain medication management with the pharmacology class of Oxycodone * Systemic NSAIDS use \>/=750 mg daily * Clinically significant macular edema * History of cystoid macular edema in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intraocular Pressure from Baseline | 30 days - IOP measured at day 1, day 14 and day 30 | Sustained tapered release of Dextenza compared to Durezol 4 week taper as measured by mean IOP from baseline. |
Countries
United States
Outcome results
None listed