Dextenza in Pterygium Surgery

Phase 4

Completed

• Conditions: Pterygium
• Interventions: Drug: Dexamethasone Intracanalicular Insert, 0.4mg; Drug: Prednisolone Acetate 1%

• Registration Number: NCT04403516
• Lead Sponsor: Michelle Rhee MD

Brief Summary

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)

Detailed 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.

Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-27
• Study Start: 2020-10-01
• Primary Completion: 2021-08-05
• Study Completion: 2021-08-05
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DEXTENZA Group	Dexamethasone Intracanalicular Insert, 0.4mg	Patients with Pterygium DEXTENZA Group
Topical Prednisolone Acetate 1% Group	Prednisolone Acetate 1%	Patients with Pterygium Topical Prednisolone Acetate 1% Group

Primary Outcome Measures

Name	Time	Method
Patient satisfaction-comfort and convenience	Assessed on Month 6	Assessed by patient reported questionnaire

Secondary Outcome Measures

Name	Time	Method
To compare the degree of conjunctival hyperemia	Assessed on Month 6	Assessed by clinical external photography
Mean number of days for corneal re-epithelialization	Assessed on Month 1	As evaluated by slit lamp examination
Recurrence of pterygium	Assessed at Month 6	As measured by yes or no on recurrence; external eye examination

Trial Locations

Locations (1)

New York Eye Specialists; 🇺🇸 New York, New York, United States