Macular Pucker, Retinal Edema, Vitrectomy
Conditions
Brief summary
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel
Detailed description
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts, when placed within the lower eye lid canaliculus or both the upper and lower canaliculi for the treatment of pain, inflammation, and cystoid macular edema following 27 gauge vitrectomy with internal limiting membrane peel for the treatment of retinal edema associated with macular pucker
Interventions
DRUGDexamethasone Intracanalicular Insert, 0.4 mg
To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with one DEXTENZA (lower eye lid canaliculus) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery
DRUGPrednisone acetate 1%
To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery
Sponsors
Kovach Eye Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In patients who undergo vitrectomy with internal limiting membrane peel surgery , subjects will be randomized to three groups and be followed for a period of two months. One group will be selected to receive one DEXTENZA (in the lower canaliculus), the second group will receive two DEXTENZA (upper and lower canaliculi) and the third group will receive prednisolone acetate 1% (control eye) . All groups will receive a subconjunctival dexamethasone injection at the time of surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A patient's study eye must meet the following criteria to be eligible for inclusion in the study: * Symptomatic macular pucker with retinal edema * Age 18 years and older * Scheduled vitrectomy and internal limiting membrane peel * Willing and able to comply with clinic visits and study related procedures * Willing and able to sign the informed consent form
Exclusion criteria
A patient who meets any of the following criteria will be excluded from the study: * Patients under the age of 18 * Pregnancy ( must be ruled out in women of child-bearing age with pregnancy test) * Active infectious systemic disease * Active infectious ocular or extraocular disease * Obstructed nasolacrimal duct in the study eye (s) * Hypersensitivity to dexamethasone or prednisolone eye drops * Patients being treated with immunomodulating agents in the study eye(s) * Patient being treated with immunosuppressants and/or oral steroids * Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in retina edema | assessed on day 30 and day 60 | As measured by Optical Coherence Tomography (OCT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in Inflammation ( Cell and Flare) | as assessed on days 1, 7, 30, 60 | As measured by SUN (Standardization of Uveitis Nomenclature) grading scale;absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of 0-1 |
| Mean change in pain scores | as assessed on days 1, 7, 30, 60 | as measured with the visual analog scale (VAS); between 0 and 10; 0 meaning no pain and 10 meaning worst pain possible |
| Mean Change in Best- Corrected Visual Acuity (BCVA) | from baseline at days 1, 7, 30, 60 | as measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart |
| Physician ease of Dextenza insertion | as assessed on day of surgery | measured by a 0-10 scale |
Countries
United States
Contacts
Primary ContactSaad Ahmad, MD
Backup ContactJamie White, Bachelors
Outcome results
None listed