Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Clinical Research Consultants, Inc.
Age
22–95
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
In good general health
Between 22 and 95 years of age and diagnosed with cataract(s)
Able to comprehend and sign a written statement of informed consent for participation in the study, including HIPAA
Undergoing cataract extraction surgery with an Alcon SN6 platform intraocular lens implantation into the posterior chamber
Clear intraocular media, other than cataract
Potential postoperative best-corrected visual acuity (BSCVA) of 20/30 or better
Axial length of ≥ 22.00 and ≤ 28.00
You may not be if
Concurrent participation in another investigational drug or device study or participation in another study within the last 30 days prior to Screening
Has had prior laser vision correction and/or corneal surgery
Has a complication during surgery unrelated to ORA use
Conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma or posterior capsule defects
History of infectious corneal disease (e.g., herpes simplex, herpes zoster, etc.) or other conditions which may result in corneal scarring
Significant central opacity/scar
Irregular astigmatism based upon investigator judgment
Inability to achieve keratometric stability
Will require another procedure, such as iris hooks, use of a Malyugin ring or insertion of a capsular tension ring during surgery
Will require significant sedation during surgery
Subject who is unable to maintain adequate fixation for image capture with ORA
Keratopathy/Kerectasia - any corneal abnormality, other than regular corneal astigmatism, including, but not limited to the following: corneal leukoma and pterygium
Any inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis
May reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy)
Amblyopia
Corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy)
Endothelial disease that may potentially affect visual outcome
Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted (by subjective assessment of the retina) to cause future acuity losses to a level worse than 20/30 and/or that the investigator deems would interfere with acquiring images or determining a precise postoperative refraction
Shallow anterior chamber, not due to swollen cataract
History of retinal detachment or macular pucker
Ocular conditions such as keratoconus, forme fruste keratoconus or recurrent erosion syndrome that may predispose the subject to complications
Microphthalmos
Previous corneal transplant
Recurrent severe anterior or posterior segment inflammation of unknown etiology
Rubella or traumatic cataract
Iris neovascularization
Uncontrolled glaucoma or glaucoma with visual field defects
Poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
Prior, current, or anticipated use during the course of the study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) likely, in the opinion of the Investigator, to cause poor dilation or lack of adequate iris structure to perform standard cataract surgery
Aniridia
Optic nerve atrophy
Uncontrolled systemic disease or acute or chronic disease or illness that would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, multiple sclerosis, lupus, hepatitis, rheumatoid arthritis, etc.)
Uncontrolled/poorly controlled diabetes
Uncontrolled ocular hypertension (≥ 22 mmHg)
Active intraocular inflammation or recurrent ocular inflammatory \\ condition (e.g., recurrent or persistent iritis, iridocyclitis, posterior uveitis, etc.)
Use of systemic or ocular medications that may affect vision
Recent ocular trauma that is not resolved/stable or may affect visual outcomes
Previous ocular surgery such as pterygium removal, tear duct surgery, radial keratectomy, etc.
Pregnant women, nursing women and subjects suspected of being pregnant
Subjects who, in the judgment of the investigator or sub-investigator, are inadequate for the study
