Actively Recruiting
A Prospective Trial Evaluating an Intracanalicular Insert Delivery System Compared to Traditional Eye Drops for Controlling Post-operative Pain and Inflammation in Patients Undergoing Sequential Bilateral Cataract Surgery
Led by Ophthalmic Consultants of Long Island · Updated on 2019-12-20
50
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
Sponsors
O
Ophthalmic Consultants of Long Island
Lead Sponsor
O
Ocular Therapeutix, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates patient preference and the safety and eye-related effectiveness of a new treatment method called Dextenza combined with an intracameral antibiotic and NSAID, compared to standard eye drop therapy after cataract surgery. The study involves patients undergoing surgery in both eyes and aims to control pain and inflammation following the procedures. Participants will be randomly assigned to receive either the experimental treatment or the standard topical therapy in their first eye surgery. The experimental group receives a Dextenza dexamethasone intracanalicular insert placed in the lower punctum during surgery, along with intracameral ketorolac and moxifloxacin administered during and after the procedure. The control group receives standard topical drops including moxifloxacin, ketorolac, and prednisolone acetate at scheduled intervals before and after surgery. Two weeks later, the second eye will be operated on and treated with the alternate treatment. During the study, participants will attend several visits for assessments including patient preference measured 28 days after the second eye surgery, ocular inflammation scores, post-operative pain ratings, visual acuity tests, physician evaluations of insertion, and monitoring for adverse events. These evaluations occur at various time points up to two months following the second surgery, enabling researchers to compare the treatments comprehensively and monitor safety and effectiveness over time.
CONDITIONS
Brief Title
A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults over 22 years old in good general health
- Willing and able to sign informed consent
- Women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test, and use effective birth control
- Availability and willingness to comply with exam procedures and scheduled visits
- Planned routine cataract surgery with intraocular lens implantation
You will not qualify if you...
- History of complications or disease in the tear drainage area (nasolacrimal area) including infections or inflammation
- Structural lid abnormalities in the eye scheduled for surgery
- Puncta size greater than 0.9 mm before dilation in the scheduled surgical eye
- Significant ocular pain or discomfort at screening or plug insertion day
- Moderate to severe lid, conjunctival, or corneal findings at screening
- Signs of intraocular inflammation at screening
- Known allergies or sensitivities to study medications or NSAIDs
- History of steroid response
- Lens capsule or zonular abnormalities that affect lens positioning
- History of ocular trauma or prior intraocular surgery within specified recent timeframes
- Pupil abnormalities or corneal abnormalities in the scheduled surgical eye
- Evidence of keratoconus or irregular astigmatism
- Use of certain contact lenses within specified timeframes before surgery
- History of chronic or recurrent inflammatory eye diseases
- Uncontrolled glaucoma
- Need for certain additional eye procedures before, during, or after surgery
- Use of systemic or eye medications that affect vision or inflammation during the study
- Acute or chronic diseases increasing risk or confounding results
- Uncontrolled systemic diseases or poorly controlled diabetes
- Participation in another clinical trial within 30 days before enrollment
- Specific intra-operative surgical complications as listed in the protocol (e.g., capsular rupture, vitreous loss, floppy iris syndrome)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 1 month before first cataract surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for initial consultation and randomization
Duration - Day of first eye surgery
Participants undergo cataract surgery on the first eye and receive assigned treatment either with a dexamethasone intracanalicular insert or traditional eye drops during and immediately after surgery.
1 visit (in-person) for surgery and treatment administration
Duration - Up to 1 month after first eye surgery
Participants are monitored for post-operative pain, inflammation, and healing following the first eye surgery while using the assigned treatment.
Multiple visits, including Day 1 (insertion evaluation for experimental group), Day 7, and Day 14 post-op visits
Duration - Day of second eye surgery
Participants undergo cataract surgery on the second eye approximately 2 weeks after the first eye and receive the alternate treatment not used on the first eye.
1 visit (in-person) for second surgery and treatment administration
Duration - Up to 1 month after second eye surgery
Participants are monitored for post-operative pain, inflammation, and healing following the second eye surgery while using the alternate treatment.
Multiple visits including Day 7, Day 14, and Day 28 post-op visits, with a 2-month visit for visual acuity and safety assessments
Trial Site Locations
Total: 1 location
1
Ophthalmic Consultants of Long Island
Garden City, New York, United States, 11530
Actively Recruiting
Research Team
E
Erin Loweree
I
Isabel Lezcano
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
2
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