Cataract Surgery, Glaucoma Surgery
Conditions
Brief summary
To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by - Modified COMTOL survey.
Detailed description
Eyes from 80 patients will be randomized in a 1:1 ratio to the assigned treatment, dexamethasone insert placed at the time of surgery, or topical prednisolone acetate 1% therapy prescribed on a tapering dose schedule post-operatively. Males and Females 18 years and older with 1)Presence of a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens (IOL), and potential postoperative Snellen pinhole corrected distance visual acuity (CDVA) of at least 20/200 in both eyes and 2) 10 patients with mild-to-moderate primary open angle glaucoma and a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber Intraocular Len (IOL) combined with a Minimally Invasive Glaucoma Surgery (MIGS) procedure in both eyes. Study visits will consist of eye exam with ocular photos from an Optical Coherence Tomography (OCT).
Interventions
The eye will have a sustained release device of Dexamethasone 0.4 mg placed in the inferior nasal lacrimal system.
The eye will be randomized to receive topical treatment with prednisolone acetate 1% on a tapering dose schedule
Sponsors
Ocular Therapeutix, Inc.
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older * Presence of a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens (IOL), and potential postoperative Snellen pinhole CDVA of at least 20/200 in both eyes * 10 patients with mild-to-moderate primary open angle glaucoma and a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber IOL combined with a Minimally Invasive Glaucoma Surgery (MIGS) procedure in both eyes
Exclusion criteria
* 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 pharmacologic class of oxycodone * Systemic NSAID use o Pre-procedural wash-out period for topical NSAIDS, ocular steroid, cyclosporine of 7 days * Clinically significant macular edema (CSME) * History of cystoid macular edema in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of patients who stated they preferred topical prednisolone insert as measured by patient report | 45 days post second surgery | To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey. |
| Percent of patients who stated they preferred dexamethasone insert as measured by patient report | 45 days post second surgery | To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of inflammation | Day 14 post surgery | Resolution of inflammation as defined as either 0 or 0.5 cells or less cells on post-surgical day 14 as measured by SUN scale in an unmasked fashion. |
| Resolution of pain | Day 7 post surgery | Resolution of pain as defined by a score of 0 measured by pain scale on post-surgical day 7 |
| Absence of cell flare at day 14 | Day 14 post surgery | Absence of cell flare at day 14 |
| The incidence of AE | Up to 3 months | The incidence of adverse events |
| Mean change in central retinal thickness as measured by OCT | Baseline, 3 months | Mean change in central retinal thickness as measured by OCT |
| Percent of patients who maintained normalized central retinal thickness at 28 days post surgery | 28 days post surgery | Percent of patients who maintained normalized central retinal thickness at 28 days post surgery |
| Percent of patients with rebound inflammation | Up to 3 months | Percent of patients with rebound inflammation |
| Mean change in BCVA | Baseline, 3 months | Mean change in BCVA |
| The severity of AE | Up to 3 months | The severity of adverse events |
Outcome results
None listed