Trial | NCT04403516  Report issue

Official Title

Dextenza in Pterygium Surgery

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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)
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 Started
Oct 01
2020
Primary Completion
Aug 05
2021
Study Completion
Aug 05
2021
Last Update
Apr 06
2022

Drug 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.

Drug Prednisolone Acetate 1%

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

DEXTENZA Group Experimental

Patients with Pterygium DEXTENZA Group

Topical Prednisolone Acetate 1% Group Experimental

Patients with Pterygium Topical Prednisolone Acetate 1% Group

Criteria 

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
No Results Posted