Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment
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.
|Condition or Disease||Intervention/Treatment||Phase|
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.
Arms and Interventions
|Experimental: Intracanalicular Sustained Release Dexamethasone, 0.4 mg|
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.
Intracanalicular sustained release dexamethasone insert 0.4 mg
|Active Comparator: topical prednisolone acetate 1%.|
Drug: Prednisolone Acetate
Topical Prednisolone acetate 1% ophthalmic suspension
Primary Outcome Measures
- 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
- 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)
- 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.
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
Contacts and Locations
|1||Midwest Eye Institute||Indianapolis||Indiana||United States||46290|
Sponsors and Collaborators
- Midwest Eye Institute
- Ocular Therapeutix, Inc.
- Principal Investigator: Neil Finnen, MD, Midwest Medical Advisors, Inc
Study Documents (Full-Text)None provided.
- The FINNEN Study