Corneal Edema, Corneal Defect, Corneal Transplant, Penetrating KeratoPlasty, Anterior Chamber Inflammation, Ocular Pain, Intraocular Pressure
Conditions
Brief summary
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert following corneal transplant surgery (PKP, DSEK, DMEK) as compared to topical prednisolone acetate 1%.
Detailed description
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert, when placed within the lower or upper eye lid canaliculus in conjunction with topical prednisolone acetate 1% for the treatment of pain, and inflammation following corneal transplant surgery (PKP, DSEK, DMEK) as compared to topical prednisolone acetate 1%.
Interventions
DEXTENZA is a corticosteroid 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 used as a topical drop after corneal transplant to decrease inflammation and prevent graft rejection
Sponsors
Nicole Fram M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In patient who undergo corneal transplant (PKP,DSEK,DMEK), subjects will be randomized to 6 arms and be followed for a period of 3 months. First arm will Receive Dextenza with PKP, Second arm will receive Prednisolone Acetate 1% with PKP, Third arm will Receive Dextenza with DSEK, Forth arm will receive Prednisolone Acetate 1% with DSEK Fifth arm will Receive Dextenza with DMEK, Sixth arm will receive Prednisolone Acetate 1% with DMEK
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: * Age 18 years and older * Scheduled corneal transplant surgery: PKP, DSEK, DMEK * 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 * Presence of punctal plug in the study eye * 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) * Patients 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 pain score | Assessed on Day 1,7 and 30 | as measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible |
| Mean change in inflammation (Cell and Flare) scores | Assessed on Day 1,7 and 30 | as 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in duration to corneal re-epithelization | Assessed on Day 1 and 7 | as measured by clinical observation of percentage (%); between 0 to 100%; 0 meaning complete re-epithalization and 100% meaning total corneal defect |
| Mean change in size of epithelial defect | Assessed on Day 1 and 7 | as measured by diameter (mm) of defect; 0 meaning no defect |
| Impact on the practice/medical team of decreasing the drop burden | Assessed on day 30 | as measured by a questionnaire |
| Mean change in duration to clearing of corneal edema | Assessed on Day 30, 60 and 90 | as measured by clinical observation; between 0 to 3; 0 meaning clear cornea and 3+ meaning complete obscuration of anterior chamber and iris |
Countries
United States
Outcome results
None listed