Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery
NCT ID: NCT04687800
Last Updated: 2022-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
1 participants
INTERVENTIONAL
2020-12-01
2022-10-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigate, Following Cataract Surgery With IOL in Conjunction With Intracanalicular Dexamethasone Insert
NCT04465864
Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction
NCT06483750
Cataract Surgery with Near Normal Eye Pressure in Patients with Diabetic Retinopathy
NCT06617273
OTX-14-002: Device Exposure Registry
NCT02309736
Comparison of Femto-laser and Manually Created Clear Corneal Incisions During Cataract Surgery
NCT04082273
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dextenza 0.4mg
Intracanalicular insert
Dextenza 0.4mg intracanalicular Insert
intracanalicular insert delivery system
Durezol 0.05%
difluprednate ophthalmic emulsion
Durezol 0.05% Ophthalmic Emulsion
Standard therapy, topical steroid drop
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dextenza 0.4mg intracanalicular Insert
intracanalicular insert delivery system
Durezol 0.05% Ophthalmic Emulsion
Standard therapy, topical steroid drop
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mild-to-moderate primary open angle glaucoma and visually significant cataract with plans to undergo clear cornea cataract surgery with Phacoemulsification and implantation of posterior chamber IOL combined with minimally invasive glaucoma surgery ( MIGS) procedure in both eyes.
Exclusion Criteria
* Previous Corneal surgery or pathology
* Active or history of chronic or recurrent inflammatory eye disease in either eye
* Ocular Pain in either eye
* Proliferative diabetic retinopathy in either eye
* Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye.
* Laser or incisional ocular surgery during the study period and 6 months prior in either eye
* Systemic concomitant pain medication management with the pharmacology class of Oxycodone
* Systemic NSAIDS use \>/=750 mg daily
* Clinically significant macular edema
* History of cystoid macular edema in either eye
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ocular Therapeutix, Inc.
INDUSTRY
Cathleen McCabe MD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Cathleen McCabe MD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cathleen M McCabe, MD
Role: PRINCIPAL_INVESTIGATOR
The Eye Associates of Manatee
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Eye Associates of Manatee
Bradenton, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Sponsor/ site website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
The McTENZA Study
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.