Dextenza in Pterygium Surgery

Study Overview
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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)

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.

Official Title
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Dextenza in Pterygium Surgery

Conditions
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Pterygium

Intervention / Treatment
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* Drug: Dexamethasone Intracanalicular Insert, 0.4mg
* Drug: Prednisolone Acetate 1%


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEXTENZA Group<br>Patients with Pterygium DEXTENZA Group | Drug: Dexamethasone Intracanalicular Insert, 0.4mg<br>* To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo pterygium surgery.<br>|
| Experimental: Topical Prednisolone Acetate 1% Group<br>Patients with Pterygium Topical Prednisolone Acetate 1% Group | Drug: Prednisolone Acetate 1%<br>* To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction-comfort and convenience | Assessed by patient reported questionnaire | Assessed on Post-Op Day 1 | 
| Patient satisfaction-comfort and convenience | Assessed by patient reported questionnaire | Assessed on Week 1 | 
| Patient satisfaction-comfort and convenience | Assessed by patient reported questionnaire | Assessed on Month 1 | 
| Patient satisfaction-comfort and convenience | Assessed by patient reported questionnaire | Assessed on Month 3 | 
| Patient satisfaction-comfort and convenience | Assessed by patient reported questionnaire | Assessed on Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the degree of conjunctival hyperemia | Assessed by clinical external photography | Assessed on Week 1 | 
| To compare the degree of conjunctival hyperemia | Assessed by clinical external photography | Assessed on Month 1 | 
| To compare the degree of conjunctival hyperemia | Assessed by clinical external photography | Assessed on Month 2 | 
| To compare the degree of conjunctival hyperemia | Assessed by clinical external photography | Assessed on Month 3 | 
| To compare the degree of conjunctival hyperemia | Assessed by clinical external photography | Assessed on Month 6 | 
| Mean number of days for corneal re-epithelialization | As evaluated by slit lamp examination | Assessed on Post-Op Day 1 | 
| Mean number of days for corneal re-epithelialization | As evaluated by slit lamp examination | Assessed on Week 1 | 
| Mean number of days for corneal re-epithelialization | As evaluated by slit lamp examination | Assessed on Month 1 | 
| Recurrence of pterygium | As measured by yes or no on recurrence; external eye examination | Assessed at Month 1 | 
| Recurrence of pterygium | As measured by yes or no on recurrence; external eye examination | Assessed at Month 2 | 
| Recurrence of pterygium | As measured by yes or no on recurrence; external eye examination | Assessed at Month 3 | 
| Recurrence of pterygium | As measured by yes or no on recurrence; external eye examination | Assessed at Month 6 |