A Phase 4 interventional study of Dexamethasone Intracanalicular Insert, 0.4mg and Prednisolone Acetate 1% in Pterygium, sponsored by Michelle Rhee MD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Michelle Rhee MD · Phase 4, Interventional, and Treatment
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.
109 studies on the registry are indexed under Pterygium; 9 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 93 interventional studies indexed under Pterygium.
Browse Pterygium studies →This is the only study on the registry with Michelle Rhee MD as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from the study:
Patients with Pterygium DEXTENZA Group
Drug: Dexamethasone Intracanalicular Insert, 0.4mg
Patients with Pterygium Topical Prednisolone Acetate 1% Group
Drug: Prednisolone Acetate 1%
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.
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
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
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Prednisolone acetate