A Study to Evaluate the Safety and Effectiveness of Dextenza® to Treat Ocular Pain and Inflammation Following Pediatric Cataract Surgery

Overview

About this study

The purpose of this study is to assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • The subject’s Legally Authorized Representative (LAR) provides written informed consent, approved by the appropriate Institutional/Independent Review Board and is able to comply with study requirements and visit schedule.
  • Is 0-3 years of age.
  • Has a cataract and is expected to undergo cataract surgery with or without implantation of a posterior chamber intraocular lens.
  • To be eligible for participation, subjects must undergo primary cataract surgery.

Exclusion Criteria:

  • Any intraocular inflammation in the study eye.
  • Over 3 years of age.
  • Ocular hypertension or glaucoma.
  • Evidence of acute external ocular infections.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Erick Bothun, M.D.

Open for enrollment

Contact information:

Suzanne Wernimont CCRP

(507) 266-4326

Wernimont.Suzanne@mayo.edu

More information

Publications

Publications are currently not available
.

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