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Compares treatment options for Cataract
Official title Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC
ClinicalTrials.gov ID: NCT06681688
What this study is testing
What is Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide}?
Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide} is an investigational medicine, given as an once-daily, being studied as a potential treatment for cataract.
Also referred to as (OMIDRIA), Phenylephrine (1%) and Ketorolac (0.3%) intraocular solution.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, 2-arm, randomized, prospective study of patients slated for bilateral cataract extraction. One eye will be randomized to the Study Arm, and the fellow eye will be randomized to the Control Arm.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult participants \> 18 years of age undergoing bilateral cataract surgery
- Able to provide written informed consent prior to any study related procedure
- Able and willing, as assessed by the Investigator, to follow study instructions, complete study assessments, comply with the protocol, and attend...
- Patients deemed to be "higher risk" for postoperative complications (e.g., well-controlled diabetes (HbA1c ≤7.0), history of uveitis, history of...
- Participants who do not meet the
You likely can't join if
- may be enrolled. Exclusion Criteria:
- Cataract surgery combined with any other procedure (e.g., glaucoma, retina, etc.)
- Glaucoma patients or known steroid responders
- Oral anti-inflammatory medications to treat a systemic disease (exceptions to this include 81 mg aspirin, ibuprofen for headache, etc.)
- Intraocular injection within 6 months
- Any prior ocular implant
See the full eligibility criteria
- Adult participants \> 18 years of age undergoing bilateral cataract surgery
- Able to provide written informed consent prior to any study related procedure
- Able and willing, as assessed by the Investigator, to follow study instructions, complete study assessments, comply with the protocol, and attend study visits for the duration of the study
- Patients deemed to be "higher risk" for postoperative complications (e.g., well-controlled diabetes (HbA1c ≤7.0), history of uveitis, history of retinal vein occlusion, history of epiretinal membrane, history of...
- Participants who do not meet the
- may be enrolled. Exclusion Criteria:
- Cataract surgery combined with any other procedure (e.g., glaucoma, retina, etc.)
- Glaucoma patients or known steroid responders
- Oral anti-inflammatory medications to treat a systemic disease (exceptions to this include 81 mg aspirin, ibuprofen for headache, etc.)
- Intraocular injection within 6 months
- Any prior ocular implant
- Diagnosis of retinal thickening in the study eye within 12 months of enrollment
- Inability to provide informed consent
- Participation in another clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Venice, Florida, United States
- Racine, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Venice, Florida, United States; Racine, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.