Dextenza in Pterygium Surgery

Michelle Rhee MD

Status and phase: Completed; Phase 4

Conditions: Pterygium

Treatments: Drug: Dexamethasone Intracanalicular Insert, 0.4mg; Drug: Prednisolone Acetate 1%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04403516

Dextenza in Pterygium Surgery

Details and patient eligibility

About

DEXTENZA for the treatment of post-surgical pain and inflammation compared to standard of care topical prednisolone acetate 1% in patients who undergo pterygium surgery (excision of pterygium with conjunctival autograft)

Full description

In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive either DEXTENZA or topical prednisolone acetate 1%.15 eyes will receive a Dextenza insertion into both the upper and lower puncta at the time of surgery, followed by at postoperative month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks then discontinued. 15 eyes will receive starting on postoperative day 1 topical prednisolone acetate 1% q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks then discontinued.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

• Age of at least 18 years with primary pterygia

Exclusion criteria

A patient who meets any of the following criteria will be excluded from the study:

• Glaucoma
• Ocular hypertension
• Prior conjunctival surgery
• Other uncontrolled ocular disease
• Ocular surgery in either eye within 3 months
• Use of eye drops other than postoperative medications and artificial tears

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

DEXTENZA Group

Experimental group

Description:

Patients with Pterygium DEXTENZA Group

Treatment:

Drug: Dexamethasone Intracanalicular Insert, 0.4mg

Topical Prednisolone Acetate 1% Group

Experimental group

Description:

Patients with Pterygium Topical Prednisolone Acetate 1% Group

Treatment:

Drug: Prednisolone Acetate 1%