Phase
Condition
Vision Loss
Eye Disorders/infections
Eye Disease
Treatment
Model Series ZXT
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female patients at least 18 years of age
Have a cataract in one or both eyes, with planned phacoemulsification withintraocular lens implantation
Have estimated postoperative visual acuity of at least 20/25 Snellen (0.8 decimal)in the eye to be implanted per surgeon estimate \
Regular corneal astigmatism and predicted postoperative residual astigmatism of lessthan 1.00 D after implantation with a toric intraocular in the study eye(s)
Availability, willingness and sufficient cognitive awareness to understand thepurpose of the examination procedures and comply with postoperative visits that arerequired by the study protocol
Voluntary participation indicated by the study informed consent form (ICF) signed bythe patient or legal guardian.
Exclusion
Exclusion Criteria:
Concurrent participation or participation in any other clinical study within 30 daysprior to the preoperative visit
Ocular disease (other than cataract) that may significantly affect postoperativevision, such as visually significant keratopathy, macular lesions, diabeticretinopathy, chronic or severe uveitis, etc.
Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery,including prophylactic peripheral iridotomies and peripheral laser retinal repairs
Irregular corneal astigmatism
Inability to achieve keratometric stability for contact lens wearers (as defined inSection 10.3 Preoperative Procedures)
Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration orother retinal disorders) that are predicted to cause visual acuity loss to a levelworse than 20/30 Snellen (0.67 decimal) during the study
Subjects with conditions associated with increased risk of zonular rupture,including capsular or zonular abnormalities that may lead to IOL decentration ortilt, such as pseudoexfoliation, trauma, or posterior capsule defects
Use of systemic or ocular medications that may affect vision, confound the outcomeor increase the risk to the subject (e.g., poor dilation or a lack of adequate irisstructure to perform standard cataract surgery)
Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in theopinion of the investigator, would increase the operative risk or confound theoutcome(s) of the study (e.g., immunocompromised, connective tissue disease,suspected glaucoma, glaucomatous changes in the fundus or visual field, ocularinflammation, etc.). Note: controlled ocular hypertension without glaucomatouschanges (optic nerve cupping and visual field loss) is acceptable.
Planned monovision correction (one eye designated for near correction).
Patients who are pregnant or nursing.
Severe or unstable systemic disease that may affect the heart, liver, kidney, lung,endocrine (including thyroid insufficiency), blood, or psychoneurologicaldysfunction
Any other systemic or ocular disease that, in the opinion of the investigator, mayaffect the patient's eligibility for the study, affect visual acuity or may requiresurgical intervention during the course of the study (e.g., macular degeneration,cystoid macular edema, diabetic retinopathy, etc.).
Study Design
Connect with a study center
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009
ChinaSite Not Available

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