Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT07276802
Eligibility Criteria:
Inclusion Criteria:
* A male or female subject in good general health, \> 22 years of age at the time of the screening visit
* A subject must be able to comprehend and willing to give informed consent
* A woman of child-bearing potential must not be pregnant or lactating.
* 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
* A subject with clear ocular media other than cataract in their scheduled operative eye
* A subject with normal OCT of the macula in both eyes
* A subject has the potential for a post-operative Snellen BCDVA of 20/30 or better in both eyes
Exclusion Criteria:
* 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 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 history as a steroid responder or glaucoma
* 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 only one eye with potentially good vision
* A subject with a known pathology that may affect visual acuity (as determined by the Investigator); particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) in their scheduled surgical eye
* A subject that has a condition associated with the fluctuation of hormones that could lead to refractive changes
* A subject with amblyopia or strabismus
* 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 clinically significant corneal abnormality (e.g., stromal, epithelial or endothelial dystrophies) that, in the best judgment of the investigator, is likely to interfere with the outcomes of the study
* 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 the use of systemic 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, other source of 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.
Intra-Operative Exclusion Criteria (Surgical Complications):
* Sulcus-sulcus or bag-sulcus fixation
* Posterior capsular rupture or zonular dialysis
* Disruption of anterior hyaloid face
* Vitreous loss
* Floppy iris syndrome
* Inability to place IOL in capsular bag
* Significant anterior chamber hyphema
* Significant zonular rupture.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT07276802
Study Brief:
Protocol Section:
NCT07276802