Dextenza in Pterygium Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-08-05

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Pterygium

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive either DEXTENZA (15 eyes) 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 or receive topical prednisolone acetate 1% (15 eyes) q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks then discontinued.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DEXTENZA Group

Patients with Pterygium DEXTENZA Group

Group Type EXPERIMENTAL

Dexamethasone Intracanalicular Insert, 0.4mg

Intervention Type DRUG

To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo pterygium surgery.

Topical Prednisolone Acetate 1% Group

Patients with Pterygium Topical Prednisolone Acetate 1% Group

Group Type EXPERIMENTAL

Prednisolone Acetate 1%

Intervention Type DRUG

To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery.

Interventions

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Dexamethasone Intracanalicular Insert, 0.4mg

To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo pterygium surgery.

Intervention Type DRUG

Prednisolone Acetate 1%

To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No