Treatment of pain and inflammation after eye surgery using DEXTENZA
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.
This study is testing if a new eye treatment called DEXTENZA can help reduce pain and swelling after a specific eye surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kovach Eye Institute Industry-sponsored |
| Locations | 1 site (Elmhurst, Illinois) |
| Trial ID | NCT04501367 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of DEXTENZA, a sustained release dexamethasone insert, for managing pain, inflammation, and cystoid macular edema following a specific eye surgery known as 27 gauge vitrectomy with internal limiting membrane peel. Participants will receive the insert placed in the lower eyelid canaliculus or both upper and lower canaliculi. The study aims to determine how well this treatment works in alleviating symptoms associated with retinal edema due to macular pucker.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for vitrectomy due to symptomatic macular pucker with retinal edema.
Not a fit: Patients under 18, pregnant women, or those with certain active infections or hypersensitivities will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and inflammation for patients recovering from eye surgery.
How similar studies have performed: Other studies using sustained release dexamethasone for ocular conditions have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible for inclusion in the study: * 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 Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study: * 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
Where this trial is running
Elmhurst, Illinois
- Kovach Eye Institute — Elmhurst, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Saad Ahmad, MD — Kovach Eye Institute
- Study coordinator: Saad Ahmad, MD
- Email: ifixretinas@gmail.com
- Phone: 6308339361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.