Patient Preference, Patient Outcomes, Post-Operative Inflammation, Grade of Post-Operative Cystoid Macular Edema, Rate of Post-Operative Cystoid Macular Edema
Conditions
Brief summary
To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.
Detailed description
A Randomized, Controlled, Prospective Study design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1week, following bilateral RLE surgery. All eyes will receive topical moxifloxacin QID for one week and topical Ilevro QD for 4 weeks. Moxifloxacin and Ilevero are used in post-op regardless of the research. Post-operative evaluations to be performed on Day 1, Day 7, and 1 Month.
Interventions
DRUGDextenza
Dextenza 0.4mg
Standard of care topical drop treatment
Sponsors
Vance Thompson Vision - MT
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better * Willing and able to comply with clinic visits and study related procedures * Willing and able to sign the informed consent form
Exclusion criteria
* Patients under the age of 22 or above the age of 75 * Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test). * Patients with active infectious ocular or extraocular disease. * Patients actively treated with local or systemic immunosuppression including systemic corticosteriods * Paitents with know hypersensitivity to Dexamethasone * Patients with severe disease that warrants critical attentino, deemed unsafe for the study by the investigator * Patients with a history of ocular inflammation or macular edema * Patients with allergy or inability to receive intracameral antibiotic * Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) grater than 1,200 mg/day * Patient with a corticosteriod implant (i.e. Ozurdex). * Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Preference | Through Month 1 | As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) survey (This is measured on a scale of 1-10 with 10 being a worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-operative corneal haze | Through Month 1 | measured by OCT (Optical Coherence Tomography) |
| Percentage of eyes that have CME (Cystoid macular edema) post-operatively | Through Month 1 | Measured by OCT (Optical Coherence Tomography ) |
| Grade of post-operative corneal haze | Through Month 1 | measured by OCT (Optical Coherence Tomography) |
| Mean pain score per eye (Group A vs Group B) | Through Month 1 | Measured by Visual Analog Scale (0-10, 10 being the worst outcome) |
| Uncorrected Visual Acuity | Through Month 1 | measured by ETDRS chart a 4m |
| Best Corrected Visual Acuity | Through Month 1 | measured by ETDRS chart a 4m |
| Anterior chamber cell count | Through Month 1 | measured by SUN Working Group Grading Scheme |
Countries
United States
Outcome results
None listed