Cataract
Conditions
Interventions
Experimental group:Both eyes implanted with IOLs and follow-up for 12 months
Sponsors
THE SECOND AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Eligible subjects must meet all of the following inclusion criteria: 1) Able to comprehend and sign an informed consent form. 2) Adult Chinese subjects, 18 years of age or older, diagnosed with bilateral cataracts. 3) Pre-operative regular corneal astigmatism of less than 1.0 D. 4) Planned bilateral cataract removal by routine phacoemulsification. 5) Calculated IOL power between +6.0 D and +34.0 D. (when targeted for emmetropia 0.0 D) 6) Able to complete all study visits required in the protocol. 7) Pre-operative best corrected distance visual acuity (BCDVA) worse than or equal to 0.3 LogMAR in each eye. 8) Potential postoperative best corrected distance visual acuity (BCDVA) of 0.3 logMAR or better in both eyes based on the investigator expert medical opinion.
Exclusion criteria
Exclusion criteria: Subjects who do not meet the inclusion criteria or meet any of the following exclusion criteria will be excluded: 1) History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathologic change including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, ARMD, glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve. 2) Corneal Endothelial Cell Count less than 2000 cells/mm2. 3) History of recurrent anterior segment/posterior segment inflammation. 4) Clinically significant corneal diseases (epithelium, stromal, and/or endothelium) may, according to the investigator's medical opinion, adversely affect visual outcomes. These ocular pathologies include but are not limited to old significant corneal scars (including Salzmans nodular degeneration), active or inactive keratitis with compromise of the refractive capability of the cornea, keratoconjunctivitis sicca with compromise of visual function, active keratouveitis, endothelial dystrophy (Fuchs and non-guttate),keratoconus, etc. (Note: Patients with any pathological manifestations that may potentially affect postoperative visual acuity should not be included in this study) 5) Clinically significant/severe dry eye that would affect study measurements based on the investigators expert medical opinion. 6) History of previous intraocular or corneal (refraction or trauma related) surgery. 7) Currently or planning to be pregnant/lactating or has another condition with associated fluctuation of hormones that could lead to refractive changes. 8) Current or past history of amblyopia or monofixation syndrome with poor stereoscopic vision. 9) Systemic medications that, in the opinion of the investigator, may confound the outcome or increase the risk to the subject (e.g. Tamsulosin Hydrochloride – Flomax) or other medications including anticholinergics, alpha adrenergic blocking agents with similar side effects (e.g. small pupil/floppy iris syndrome) 10) Any subject currently participating in another investigational drug or device study that may confound the results of this investigation. 11) Any other ocular or systemic co-morbidity that, in the investigators medical opinion, may confound the results of this study or prohibit the completion of the study assessments or increase the risk for the subject. 12) Subjects with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the IOL (e.g., patients of exfoliation Syndrome, Marfan syndrome). 13) Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser-assisted in situ keratomileusis (LASIK). 14) Subjects who desire monovision correction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of eyes with Best Corrected Distance Visual Acuity (BCDVA) of 0.3 LogMAR or better;Mean monocular and binocular BCDVA;Mean monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm);Mean monocular and binocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm); | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean monocular and binocular Uncorrected Distance Visual Acuity (UCDVA);Mean monocular and binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm);Mean monocular and binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm);Mean monocular manifest refraction spherical equivalent after surgery;Binocular defocus curve;IOLSAT Questionnaire; | — |
Countries
China
Contacts
Public ContactKe Yao
THE SECOND AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE
Outcome results
None listed