Actively Recruiting
A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery
Led by Ophthalmic Consultants of Long Island · Updated on 2019-12-20
50
Participants Needed
1
Research Sites
56 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
To evaluate the safety and ocular efficacy of Dextenza in combination with an intracameral antibiotic and NSAID in controlling post-operative ocular pain and inflammation compared to standard of care topical therapy in patients undergoing bilateral cataract surgery.
CONDITIONS
Official 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 in good general health, older than 22 years at screening
- 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
- Ability, willingness, and cognitive capacity to comply with exam procedures and attend all study visits
- Planned routine cataract surgery with intraocular lens implantation
You will not qualify if you...
- History of complications or disease in the nasolacrimal area, including dacryocystitis, inflammation, or canaliculitis
- Structural eyelid abnormalities such as ectropion or entropion in the surgical eye
- Puncta larger than 0.9 mm before dilation in the surgical eye
- Significant ocular pain or discomfort at screening or on plug insertion day
- Moderate to severe lid, conjunctival, or corneal issues at screening
- Signs of intraocular inflammation at screening
- Known allergy or sensitivity to study medications or NSAIDs
- History of steroid response
- Capsule or zonular abnormalities affecting lens positioning
- History of ocular trauma in the scheduled surgical eye
- Prior intraocular surgery within 6 months or laser surgery within 3 months in the surgical eye
- Pupil abnormalities affecting dilation or shape
- Corneal abnormalities or dystrophies in the surgical eye
- Evidence of keratoconus or significant irregular astigmatism
- Epithelial Basement Membrane Dystrophy
- Recent use of certain contact lenses before surgery
- Inability to achieve keratometric stability for contact lens wearers
- History of chronic or recurrent inflammatory eye disease
- Uncontrolled glaucoma
- Need for additional surgical or laser procedures during the study
- Use of systemic or ocular NSAIDs or corticosteroids during the study period
- Use of medications affecting vision, inflammation, or pain
- Acute or chronic illness increasing risk or confounding results
- Uncontrolled systemic disease or poorly controlled diabetes
- Participation in another clinical trial within 30 days prior to enrollment
- Intra-operative complications such as capsular rupture, vitreous loss, floppy iris syndrome, or inability to place intraocular lens
- Significant anterior chamber bleeding or zonular rupture
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
I
Isabel Lezcano
CONTACT
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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