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DEXTENZA VS. PREDNISOLONE ACETATE 1% Macular Edema With Diabetic Retinopathy After Cataract Surgery

NCT04362241 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-08-11

No results posted yet for this study

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

Interventions

DRUG

Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

Prednisolone Acetate 1% ophthalmic drops

Sponsors & Collaborators

  • Ophthalmic Consultants of the Capital Region

    lead OTHER

Principal Investigators

  • Robert Feldman, MD · Ophthalmic Consultants of the Capital Region

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-07
Primary Completion
2022-02-28
Completion
2022-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04362241 on ClinicalTrials.gov