Cataract Surgery
Conditions
Keywords
Dextenza, intracanalicular dexamethasone, dexamethasone ophthalmic insert, Dexycu, Omidria
Brief summary
This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.
Detailed description
Prospective, randomized trial where patients will be randomly assigned to 1 of 3 groups, each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria. Each of the drug combinations used in each of the 3 groups is standard of care, FDA approved, and will be used on label. 1:1:1, n=75 with 25 subjects assigned to each of the 3 groups.
Interventions
DRUGOmidria
phenylephrine 1% and ketorolac 0.3% intraocular solution
DRUGDextenza (dexamethasone ophthalmic insert) 0.4mg
intracanalicular dexamethasone insert
DRUGDexycu, 9% Intraocular Suspension
dexamethasone intraocular suspension
standard postoperative ophthalmic drop regimen
Sponsors
Ocular Therapeutix, Inc.
Silverstein Eye Centers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomly assigned to 1 of 3 groups (1:1:1), each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients 18 years of age or older, undergoing routine, uncomplicated cataract surgery.
Exclusion criteria
* Any history of corneal dystrophy, corneal surgery within 6 months of cataract surgery, previous intraocular surgery, any concomitant eye drop use besides artificial tears, previous ocular trauma, or a history of treated glaucoma. No additional procedures can be done at the time of cataract surgery (e.g., stent placement, endo-laser, etc.), but femto-second laser-assisted surgery is permitted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of anterior chamber inflammation | Assessed at day 8 post-operatively | The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of postoperative pain | Assessed at day 1 post-operatively | The secondary efficacy endpoint is the elimination of post-operative pain per a subjective, standardized scale. Post-operative pain as measured on a scale from 0-10 (ocular pain assessment). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Optical Coherence Tomography (OCT) | Assessed pre-operatively and 1 month post-operatively | OCT is a non-contact, non-invasive test that takes less than a minute to perform. All that is required of the patient is that they sit still and look at a fixation light while the machine takes a picture. No eye drops or any other intervention are required. OCT scanning will provide an image of the deep layers of the retina and will be used to determine macular thickness measurement (macular thickness has been correlated to changes in contrast sensitivity) before and 30 days following surgery. . |
| Contrast sensitivity testing | Assessed pre-operatively, and at 15 days and 30 days post-operatively | This test is non-contact, non-invasive and used to distinguish between finer and finer increments of light versus dark. The patient simply looks at a chart similar to the Snellen Eye Chart and distinguishes lighter shades from darker shades. The test is performed in less than one minute. |
| Best corrected visual acuity | Assessed pre-operatively, and at 15 days and 30 days post-operatively | ETDRS chart at 4m |
Countries
United States
Outcome results
None listed