Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.

Description

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel

Conditions

Vitrectomy, Macular Pucker, Retinal Edema

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Study Overview

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Study Details

Study overview

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel

Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) When Placed Within the Lower Eye Lid Canaliculus or Both the Upper and Lower Canaliculi for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.

Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.

Condition
Vitrectomy
Intervention / Treatment

-

Contacts and Locations

Elmhurst

Kovach Eye Institute, Elmhurst, Illinois, United States, 60126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Symptomatic macular pucker with retinal edema
  • * Age 18 years and older
  • * Scheduled vitrectomy and internal limiting membrane peel
  • * Willing and able to comply with clinic visits and study related procedures
  • * Willing and able to sign the informed consent form
  • * Patients under the age of 18
  • * Pregnancy ( must be ruled out in women of child-bearing age with pregnancy test)
  • * Active infectious systemic disease
  • * Active infectious ocular or extraocular disease
  • * Obstructed nasolacrimal duct in the study eye (s)
  • * Hypersensitivity to dexamethasone or prednisolone eye drops
  • * Patients being treated with immunomodulating agents in the study eye(s)
  • * Patient being treated with immunosuppressants and/or oral steroids
  • * Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kovach Eye Institute,

Saad Ahmad, MD, PRINCIPAL_INVESTIGATOR, Kovach Eye Institute

Study Record Dates

2024-12-31