Corneal Edema, Corneal Defect, Anterior Chamber Inflammation, Ocular Pain, Corneal Staining, Visual Outcome, CME - Cystoid Macular Edema
Conditions
Brief summary
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery
Detailed description
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt Treating Pain, and inflamMation Following Cataract Surgery Compared to Topical Prednisolone Acetate 1%.
Interventions
DEXTENZA 0.4Mg Ophthalmic Insert is a corticosteroid (to decrease inflammation) intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.
Prednisolone Acetate 1% is a corticosteroid (to decrease inflammation) and being used as a topical drop after cataract surgery per Standard Of Care.
DRUGProlensa 0.07% Ophthalmic Solution
Prolensa 0.07% is a NSAID (to decrease inflammation, swelling and pain) and is being used as a topical drop after cataract surgery per Standard Of Care.
Sponsors
Nicole Fram M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In patient who undergo cataract surgery, subjects will be randomized to 2 arms and be followed for a period of 3 months. Arm 1- control group, 25 subjects will receive Prednisolone Acetate 1% QID x 2 weeks then BID x 2 weeks. Arm 2 - study group, 25 subjects will receive Dextenza 0.4mg insert
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with clinically significant cataract and are planning to undergo non-complicated Clear Cornea Incision Cataract Extraction with Posterior Capsule IntraOcular Lens in one or both eyes * Are willing and able to comply with clinic visits and study related procedures * Are willing and able to sign the informed consent form
Exclusion criteria
* Under the age of 18 at the time of signing the Informed Consent Form * Pregnant or planning to become pregnant during the trial period * Have visual acuity potential of less than 20/30 as recorded by a Retinal Acuity Meter or Potential Acuity Meter glare testing * Have active infectious systemic disease * Have active infectious ocular or extraocular disease * Have punctal plug in the study eye * Have obstructed nasolacrimal duct in the study eye(s) (dacryocystitus) * Have known hypersensitivity to dexamethasone or are a known steroid responder * Have a history of ocular inflammation or macular edema * Has history of Laser Vision Correction (LASIK, PhotoRefractive Keratectomy) in the operated eye * Are currently being treated with immunomodulating agents in the study eye * Are currently being treated with immunosuppressants and/or oral steroids * Are currently being treated with corticosteroid implant (i.e Ozurdex) * Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye * Have a history of complete punctal occlusion in one or both punctum * Currently using topical ophthalmic steroid medications * Are unwilling or unable to comply with the study protocol * Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in anterior chamber inflammation (Cell and Flare) scores | Assessed on Days 1,7,30,90 | Measured by SUN (Standardization on 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. 0-4 score scale, higher scores mean a worse outcome. 0-1 Absent, 1-2 Mild, 2-3 Moderate, 4 Severe. |
| Mean change in pain score | Assessed on Day 1,7, 30 and 90 | Measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible, higher scores mean a worse outcome. 0-10 Absent, 11-30 Mild, 31-70 Moderate, 71-100 Severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual outcome (Best Corrected Visual Acuity) | Assessed on Day 1,7, 30 and 90 | Measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart. 0-70 letter read score, higher scores mean a better outcome. |
| Absence of CME (Cystoid Macular Edema) | Assessed on Day 90 | Macular thickness measured by OCT (Optical Coherence Tomography) and compared to the preop measurements, higher scores (\>over 50 microns) mean a worse outcome. |
| Mean change in corneal staining | Assessed on Day 7, 30 and 90 | measured by the National Eye Institute 0-4 score scale, higher scores mean a worse outcome. 0-1 Mild, 2-3 Moderate, 4 Severe. Total score 0-5 Mild, 6-15 Moderate, 16-20 Severe. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNicole R Fram, M.D.
Advanced Vision Care
Outcome results
None listed