Recruiting

Dextenza vs. Prednisolone Acetate

Sponsor:

Ophthalmic Consultants of the Capital Region

Code:

NCT04362241

Conditions

Retinopathy, Diabetic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

Study Details

Brief 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.

Conditions

Retinopathy, Diabetic

Study ID

NCT04362241

Start date

Aug 7, 2020

Status verified date

Aug, 2020

Completion date

Mar, 2022

Anticipated

Primary completion date

Feb, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dextenza

Sustained release Dexamethasone 0.4mg

active comparator: Prednisolone Acetate 1%

Prednisolone Acetate Ophthalmic drops

Interventions

Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

Prednisolone Acetate 1% ophthalmic drops

Primary outcome measure

  • 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. [ 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. [ 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. [ Time Frame: 60 days ]

Central Contacts and Locations

Central contacts

Suzanne Alterman, RN, BSN

518-274-3123salterman@ophthalmicconsultants.com

Locations

Ophthalmic Consultants of the Capital Region

Recruiting

Troy, New York, United States, 12180

Contacts

Suzanne Alterman, RN, BSN

518-274-3123salterman@ophthalmicconsultants.com

More Information

Sponsor

Ophthalmic Consultants of the Capital Region

Last update posted

Aug 11, 2020

Last verified

Aug, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ophthalmic Consultants of the Capital Region on 2020-08-11.