The complicated schedules for administering topical steroid eye drops combined with forgetfulness and physical difficulties instilling the drops may compromise compliance; which in turn could increase the risk for secondary complications such as PME post-cataract surgery, especially in a high-risk diabetic population. Dextenza, a sustained- release steroid insert, could help preclude adherence difficulties and provide better bioavailability, being as effective as, or more effective than steroid drops in preventing PME. The aim of this study is to assess the incidence of PME in diabetic patients undergoing cataract surgery when comparing the Dextenza insert to topical prednisolone acetate 1% drops.
This prospective, open-label, single-center, randomized, fellow-eye, investigator-sponsored clinical study seeks to investigate the incidence of PME in diabetic patients with any level of background diabetic retinopathy undergoing cataract surgery treated with a 0.4mg dexamethasone intracanalicular insert when compared to standard of care prednisolone acetate 1% QID/1 week, TID/ 1 week, BID/ 1 week, QD/1 week. Topical NSAIDs will not be used in this study and all patients will receive an intracameral injection of moxifloxacin at the end of the surgical procedure. After screening a patient for inclusion and exclusion criteria, and gaining informed consent, each eye will undergo cataract surgery on separate days. The second eye will be operated on within 60 days of the first eye's surgery. One eye will be randomized to receive the dexamethasone insert using a coin flip. The other eye will be prescribed a prednisolone acetate 0.1% eye drop QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week regimen. The dexamethasone insert will be placed 2-4 days before surgery (Day -4 to Day-2) and those randomized to receive prednisolone acetate will start 2-4 days before surgery. After surgery, each eye will be followed for a period of approximately 60 days, consisting of four post-op follow-up visits (eight total post-op visits per patient). Primary and secondary endpoints will be assessed alongside standard-of-care procedures at all study visits . Adjusting for the enrollment period, the study will last a total of approximately 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Prednisolone Acetate 1% ophthalmic drops
Ophthalmic Consultants of the Capital Region
Troy, New York, United States
RECRUITINGTo measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.
Percentage of eyes that developed post-surgical PME in each group measured on fluorescein angiography at Day 7 on Optical Coherence Tomography at Day 7 by a masked grader.
Time frame: 7 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.
Percentage of eyes that developed post-surgical PME in each group measured on optical coherence tomography at Day 30 by a masked grader.
Time frame: 30 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.
Percentage of eyes that developed post-surgical PME in each group measured on fluorescein angiography at Day 60 and on optical coherence tomography at Day 60 by a masked grader.
Time frame: 60 days
Incidence of central subfield thickness (CST) at Day 7 post op as seen on optical coherence tomography (OCT)
Mean central subfield thickness (CST) at Day 7 post op in each group and comparison between groups.
Time frame: 7days
Incidence of central subfield thickness (CST) at Day 7 post op as seen on optical coherence tomography (OCT)
Mean central subfield thickness (CST) at Day 30 post op in each group and comparison between groups.
Time frame: 30 days
Incidence of central subfield thickness (CST) at Day 60 post op as seen on optical coherence tomography (OCT)
Mean central subfield thickness (CST) at Day 60 post op in each group and comparison between groups.
Time frame: 60 days
To measure the change in CST inflammation outcomes and in diabetic patients as seen on optical coherence tomography (OCT), Dextenza compared to topical prednisolone acetate 1%.
Mean change in CST from Baseline at Day 7, Day 30 and Day 60 and comparison between groups.
Time frame: 7 days
To measure the change in CST inflammation outcomes and in diabetic patients as seen on optical coherence tomography (OCT), Dextenza compared to topical prednisolone acetate 1%.
Mean change in CST from Baseline at Day 7, Day 30 and Day 60 and comparison between groups.
Time frame: 30 days
To measure the change in CST inflammation outcomes and in diabetic patients as seen on optical coherence tomography (OCT), Dextenza compared to topical prednisolone acetate 1%.
Mean change in CST from Baseline at Day 7, Day 30 and Day 60 and comparison between groups.
Time frame: 60 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in vision in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1%.
Difference of mean ETDRS Best Corrected Visual Acuity (BCVA) between groups at Day 7 post op
Time frame: 7 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in vision in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1%.
Difference of mean ETDRS Best Corrected Visual Acuity (BCVA) between groups at Day 30 post op
Time frame: 30 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in vision in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1%.
Difference of mean ETDRS Best Corrected Visual Acuity (BCVA) between groups at Day 60 post op
Time frame: 60 days
Difference patients with absence of anterior chamber (AC) cells at Day 7 post op
Percentage of patients who had absence of Anterior Chamber (AC) cells at Day 7
Time frame: 7 days
Difference patients with absence of anterior chamber (AC) cells at Day 30 post op
Percentage of patients who had absence of Anterior Chamber (AC) cells at Day 30
Time frame: 30 days
Difference patients with absence of anterior chamber (AC) cells at Day 60 post op
Percentage of patients who had absence of Anterior Chamber (AC) cells at Day 60
Time frame: 30 days
Self reported patient experience of comfort
Self-reported patient experience of comfort (right eye vs. left eye) at Day 60.
Time frame: 60 days
Rescue Therapy
Percentage of eyes rescued in each group.
Time frame: 60 days
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