Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment
- Registration Number
- NCT04464629
- Lead Sponsor
- Midwest Eye Institute
- Brief Summary
This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate: how will pseudophakic patients respond in terms of objective and subjective outcomes, when treated with Dextenza compared to topical prednisolone acetate following gas bubble repair and laser for RD.
- Detailed Description
Subjects who have given informed consent and determined to be eligible at screening will be randomized in a 1:1 ratio to DEXTENZA (placed once in the lower punctum) or the use of topical Prednisolone acetate 1% drops (four times daily). They will be observed for a period of 3-months for both pain and inflammation of the eye.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
- Pseudophakic
- Retinal Detachment
- Age 18 years and older
- Scheduled for gas bubble repair and laser surgery following retinal detachment
- 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
- Patients being treated with immunomodulating agents in the study eye(s)
- Patients being treated with immunosuppressants and/or oral steroids
- Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intracanalicular Sustained Release Dexamethasone, 0.4 mg Dextenza Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of post-surgical inflammation and pain associated with ocular surgery. topical prednisolone acetate 1%. Prednisolone Acetate -
- Primary Outcome Measures
Name Time Method Mean change in pain score 30 Days Average change in pain based on whats reported on the Ocular Pain Assessment
Post-op pain scores 30 Days Ocular Pain Assessment: Measured on a scale from 0-10 where 0 (minimum) is no pain and 10 (maximum) is extreme pain. High reported pain means a worse outcome.
- Secondary Outcome Measures
Name Time Method Best Corrected Visual Acuity 90 days As measured on ETDRS
Physician Ease of Dextenza insertion Day 1 The investigator will grade the level of ease of insertion of the intracanalicular insert on a 0 to 10-point (0 being the minimum and 10 being the maximum) scale with 0 being very easy insertion and 10 being very hard. Difficult insertion means a worse outcome.
Mean change in anterior chamber cell and flare score 30 days Post op inflammation scores as measured on a scale of 0-4: Anterior Chamber Cell Count (Absence of cell to be defined as a grade of: 0-0.5, 4 being the maximum) and Anterior Chamber Flare Score (0 is the minimum, and 4 is the maximum). High reported cell and flare means a worse outcome.
Cystoid Macular Edema 30 days Amount of central thickness macular swelling as measured by Optical Coherence Tomography (OCT)
Trial Locations
- Locations (1)
Midwest Eye Institute
🇺🇸Indianapolis, Indiana, United States