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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo pterygium surgery.
To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery.
New York Eye Specialists
New York, New York, United States
Patient satisfaction-comfort and convenience
Assessed by patient reported questionnaire
Time frame: Assessed on Post-Op Day 1
Patient satisfaction-comfort and convenience
Assessed by patient reported questionnaire
Time frame: Assessed on Week 1
Patient satisfaction-comfort and convenience
Assessed by patient reported questionnaire
Time frame: Assessed on Month 1
Patient satisfaction-comfort and convenience
Assessed by patient reported questionnaire
Time frame: Assessed on Month 3
Patient satisfaction-comfort and convenience
Assessed by patient reported questionnaire
Time frame: Assessed on Month 6
To compare the degree of conjunctival hyperemia
Assessed by clinical external photography
Time frame: Assessed on Week 1
To compare the degree of conjunctival hyperemia
Assessed by clinical external photography
Time frame: Assessed on Month 1
To compare the degree of conjunctival hyperemia
Assessed by clinical external photography
Time frame: Assessed on Month 2
To compare the degree of conjunctival hyperemia
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Assessed by clinical external photography
Time frame: Assessed on Month 3
To compare the degree of conjunctival hyperemia
Assessed by clinical external photography
Time frame: Assessed on Month 6
Mean number of days for corneal re-epithelialization
As evaluated by slit lamp examination
Time frame: Assessed on Post-Op Day 1
Mean number of days for corneal re-epithelialization
As evaluated by slit lamp examination
Time frame: Assessed on Week 1
Mean number of days for corneal re-epithelialization
As evaluated by slit lamp examination
Time frame: Assessed on Month 1
Recurrence of pterygium
As measured by yes or no on recurrence; external eye examination
Time frame: Assessed at Month 1
Recurrence of pterygium
As measured by yes or no on recurrence; external eye examination
Time frame: Assessed at Month 2
Recurrence of pterygium
As measured by yes or no on recurrence; external eye examination
Time frame: Assessed at Month 3
Recurrence of pterygium
As measured by yes or no on recurrence; external eye examination
Time frame: Assessed at Month 6