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Compares treatment options for Patient Preference
Official title A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery
ClinicalTrials.gov ID: NCT04205916
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for patient preference.
Also referred to as Ketorolac, moxifloxacin.
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
- 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.
- Phase 4: studies an already-approved treatment
- 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 22 to 100. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- A subject has the availability, willingness and sufficient cognitive awareness to comply with exam procedures and able to return for all scheduled...
- A subject with a cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned
You likely can't join if
- 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...
- 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
See the full eligibility criteria
Who can join
- 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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. Intra-Operative Exclusion Criteria (Surgical Complications):
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Garden City, New York, 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, 22 years to 100 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Garden City, New York, 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.