Clinical trial NCT05023304: In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery
Official title: In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Vance Thompson Vision
Sponsor class: OTHER
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2021-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical outcomes with optometrist pre-surgical insertion of DEXTENZA in the clinical office setting in patients undergoing same-day cataract surgery compared to standard of care steroid therapy.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older, undergoing routine, uncomplicated, sequential bilateral cataract surgery.
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form

Exclusion Criteria:

* Patients under the age of 18.
* Patients who are pregnant (must be ruled out in women of childbearing age with pregnancy test).
* Active infectious ocular or systemic disease.
* Patients with active infectious ocular or extraocular disease.
* Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
* Patients with known hypersensitivity to Dexamethasone.
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
* Patients with proliferative diabetic retinopathy or uncontrolled diabetes as deemed by an A1C \> 10.0.
* Patients with a history of ocular inflammation or macular edema.
* Patients with a pre-existing epiretinal membrane (ERM)
* Patients with allergy or inability to receive intracameral antibiotic.
* Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day The PREPARE Study (V1) February, 2021 Page 27 CONFIDENTIAL
* Patients with a corticosteroid implant (i.e. Ozurdex).

Primary outcomes:
measure: Mean anterior chamber cell/flare score
timeFrame: post-op Day 1
measure: Mean anterior chamber cell/flare score
timeFrame: post-op Day 7
measure: Mean anterior chamber cell/flare score
timeFrame: post-op Week 4.
measure: Mean pain score
timeFrame: post-op Day 1
measure: Mean pain score
timeFrame: post-op Day 7
measure: Mean pain score
timeFrame: post-op Week 4
measure: Patient preference
timeFrame: post-op Week 4
Secondary outcomes:
measure: Incidence of increased intraocular pressure (IOP) >10mmHg above baseline
timeFrame: postop Day 1
measure: Incidence of increased intraocular pressure (IOP) >10mmHg above baseline
timeFrame: postop Day 7
measure: Incidence of increased intraocular pressure (IOP) >10mmHg above baseline
timeFrame: postop Week 4
measure: Incidence of Cystoid Macular Edema (CME)
timeFrame: post-op Week 4
measure: Physician Ease of Use
timeFrame: Day 0
measure: Eye Drop Burden
timeFrame: post-op Day 7
measure: Eye Drop Burden
timeFrame: post-op Week 4
Other outcomes:
Locations:
Study officials:
References: