Dextenza for Post-operative Treatment of Pterygium (PERSIST)

Brandon Eye Associates, PA

Status and phase: Active, not recruiting; Phase 4

Conditions: Pterygium of Both Eyes

Treatments: Drug: Prednisolone Acetate; Drug: Intracanalicular Dexamethasone, (0.4 mg) Insert

Study type: Interventional

Funder types: Other

Identifiers

NCT04351737

PERSIST Study

Details and patient eligibility

About

DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation Compared to Standard of Care Topical Cortico-steroid Treatment in Patients who Undergo Bilateral Pterygium Surgery

Full description

In patients who undergo bilateral pterygium surgery, eyes will be randomized to receive either DEXTENZA at baseline, Month 1 and Month 2 or prednisolone x 3 months. Both eyes will receive antibiotic drops four times per day for two weeks and Maxitrol ointment at bedtime for two weeks following surgery.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: patients with bilateral pterygium -

Exclusion Criteria: none

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Pterygium patients

Experimental group

Description:

patients with bilateral pterytium

Treatment:

Drug: Intracanalicular Dexamethasone, (0.4 mg) Insert

Drug: Prednisolone Acetate