DEXTENZA VS. PREDNISOLONE ACETATE 1% Macular Edema With Diabetic Retinopathy After Cataract Surgery (NCT04362241) | Clinical Trial Compass
UnknownPhase 4
DEXTENZA VS. PREDNISOLONE ACETATE 1% Macular Edema With Diabetic Retinopathy After Cataract Surgery
United States30 participantsStarted 2020-08-07
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Binocular
* \>18 years old
* Any level of Background Diabetic Retinopathy
* Cataract surgery candidate in each eye
* Pre-operative OCT and Fluorescein Angiography showing no Macular edema
Exclusion Criteria:
* Participant cannot complete second eye operation within 60 days of the first cataract surgery
* Maintains regular use of systemic or ocular steroids at time of enrollment
* Maintains regular use of systemic or ocular non-steroidal anti-inflammatory drugs at time of enrollment
* Anterior chamber cells present at time of enrollment
* Recent febrile illness that precludes or delays participation for 90 days
* Pregnancy or lactation
* Known allergy to dexamethasone
* Known allergy to prednisolone
* Preexisting retinal disease including uveitis, nondiabetic retinal disease, choroidal disorders, diabetic macular edema.
* Posterior capsule rupture or other intraoperative complication in first eye operated on
* Amblyopia
* Anti-VEGF injections within 6 months prior to surgery day.
* Intraocular steroid injection within 6 months prior to surgery day.
* Intraocular surgeries within 6 months prior to surgery day.
* Laser photocoagulation within 30 days prior to surgery day.
* Any type of eye inflammation
* Any punctum inflammation or dacryocystitis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: 7 days
2
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.
Timeframe: 30 days
3
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.
Timeframe: 60 days
Trial details
NCT IDNCT04362241
SponsorOphthalmic Consultants of the Capital Region