Patient Preference for Dropless vs. Drops After Cataract Surgery
This study is looking at whether patients prefer a "dropless" approach to medication after cataract surgery compared to using eye drops. The dropless approach involves receiving Dexamethasone (a steroid), ketorolac (an anti-inflammatory), and moxifloxacin (an antibiotic) during the surgery. The standard approach involves using moxifloxacin, ketorolac, and prednisolone acetate eye drops for several weeks after surgery. You could be eligible if you are between 22 and 100 years old and in good general health, and are planning to have cataract surgery on both eyes. The main goal is to see which treatment method patients prefer 28 days after their second eye surgery. The study aims to enroll 50 participants, but its current recruitment status is unclear.
- Study design
- This is a randomized study where you will receive one treatment for your first eye and the other treatment for your second eye, two weeks later. It plans to include 50 participants.
- What's involved
- You will have cataract surgery on both eyes, two weeks apart. You will receive either medications during surgery or use eye drops for up to one month after each surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your preference will be measured 28 days after your second eye surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04205916
A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery
Recruiting
PHASE4Ages 22+InterventionalOphthalmic Consultants of Long IslandInvestigator-initiated
~50 participants
Updated 2019-12-20 on ClinicalTrials.gov
What's tested:DexamethasoneStandard of care surgery
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient Preference
Measured over Day 28 of second eye surgery
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Eric Donnenfeld, MD · PRINCIPAL_INVESTIGATOR · Physician
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
A male or female subject in good general health (as determined by the Investigator), \> 22 years of age at the time of the screening visit
A subject must be willing and able to sign informed consent
A woman of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD), oral, dermal ("patch"), implant or injected contraceptives; tubal ligation; and barrier methods with spermicide.
A subject has the availability, willingness and sufficient cognitive awareness to comply with exam procedures and able to return for all scheduled study visits
A subject with a cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned
Exclusion
A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in either eye
A subject with structural lid abnormalities (e.g., ectropion, entropion) in their schedule surgical eye
A subject with a puncta \>0.9 mm prior to dilation in their scheduled surgical eye
A subject experiencing significant ocular pain or discomfort in either eye at the screening visit or on the day the plug is to be inserted
A subject with any moderate to severe lid, conjunctival or corneal findings in either eye at the screening visit
A subject with any signs of intraocular inflammation (cells/flare) in either eye at the screening visit
A subject with a known sensitivity to any of the study medications; A subject with a known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article
A subject with a history as a steroid responder
A subject with capsule or zonular abnormalities with preoperative lens tilt and/or decentration (e.g., Marfan's syndrome), or may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
A subject has a history of ocular trauma in their scheduled surgical eye
A subject that has undergone prior intraocular surgery in the scheduled surgical eye within the last 6 months or laser surgery within three months prior to screening
A subject with pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions) in their scheduled surgical eye.
A subject with a corneal abnormality (e.g., stromal, epithelial or endothelial dystrophies) in their scheduled surgical eye
A subject with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in their scheduled surgical eye
A subject with evidence of Epithelial Basement Membrane Dystrophy on slit-lamp exam
A subject that has been wearing Poly Methyl Metharcylate (PMMA) lenses within 6 months, gas permeable lenses within one month, or extended-wear or daily soft contact lens within 7 days of their scheduled surgery
A subject with an inability to achieve keratometric stability for contact lens wearers
A subject with a history of chronic/recurrent inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis) in either eye
A subject with uncontrolled glaucoma
A subject that requires an Limbal Relaxing Incision (LRI) or AI procedure before, during or after cataract surgery
A subject that may or is expected to undergo surgical intervention and/or ocular laser treatment prior to or during the study period
A subject that requires the use of systemic or ophthalmic Nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroid medications during the study period.
A subject that requires the use of system or ocular medications that may affect vision, ocular inflammation or pain
A subject with an acute or chronic disease, or illness, that would increase risk or confound study results (e.g., autoimmune disease, connective tissue disease, immunocompromised, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.)
A subject with an uncontrolled systemic disease: A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
A subject with diabetes that is poorly controlled
A subject currently participating or has participated in another clinical trial within 30 days prior to enrollment.
Sulcus-sulcus or bag-sulcus fixation
Posterior capsular rupture or zonular dialysis
Disruption of anterior hyaloids face
Vitreous loss
Capsulorhexis tear
Floppy iris syndrome
Requirement for the use of trypan blue, capsular tension ring or other intraocular device other than the Intra ocular lens (IOL)
Inability to place IOL in capsular bag
Significant anterior chamber hyphema
Zonular rupture.
What this trial measures
- Patient PreferenceDay 28 of second eye surgery
Patient preference for medication protocol between the two eyes as assessed by using a standard set of questions