cataract
Conditions
Interventions
Experimental group:Implant a HOYA Vivinex Gemetric Plus Toric Preloaded Intraocular Lens, model XY1-GPT2, XY1-GPT3, XY1-GPT4, XY1-GPT5,
XY1-GPT6
control group:Implant an Alcon AcrySof IQ PanOptix Toric Trifocal IOL (i.e., PanOptix Toric),
model TFNT20, TFNT30, TFNT40, TFNT50, TFNT60
Sponsors
Joint Shantou International Eye Center (JSIEC) of Shantou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult subjects with a minimum age of 18 years; 2. Planned for unilateral or bilateral cataract surgery and implantation of IOLs; 3. Pre-operative regular corneal astigmatism greater than 0.75 diopter(D) requiring treatment with the toric models of the study lens; 4. Clear intraocular media other than cataract; 5. Expected postoperative corrected distance visual acuity of 0.3 logMAR or better; 6. Subjects who require a spherical equivalent lens power from +10.00D to +30.00D and a maximum toric lens power of +3.75D at IOL plane; 7. Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Preoperative CDVA better than 0.3 LogMar (< 0.3 LogMAR) assessed by ETDRS visual chart; 2. Corneal endothelial cell count < 2000 cells/mm2; 3. Intraocular inflammation or recurrent ocular inflammatory condition; 4. Previous intraocular or corneal surgery (e.g. LASIK, LASEK, RK, PRK, etc.), including corneal refractive surgery, or retinal surgery excluding laser treatment of peripheral retinal regions not affecting vision in the opinion of the investigator; 5. Lentodonesis 1 or other capsular bag pathologies (e.g., after traumatic cataract); 6. Strabismus, amblyopia, or single eye status; 7. Pupil abnormalities (e.g., non-reactive, fixed pupils, or abnormally shaped pupils); 8. Keratoconus or irregular corneal astigmatism as estimated by surgeon (e.g., angle steep/flat ? 90° in 3mm zone; asymmetric power distribution) 9. Continuous contact lens wearing within 6 months of the preoperative examination for PMMA contact lenses, within 1 month of the preoperative examination for gas permeable lenses, or within 3 weeks of the preoperative examination for extended-wear and dailywear soft contact lenses; 10. Presence of corneal pathology affecting topography (e.g., stromal, epithelial or endothelial dystrophy); 11. Previous retinal detachment or vitreous detachment impacting visual acuity and/or requiring treatment; 12. Acute, chronic, or uncontrolled systemic or ocular disease or illness in the opinion of the investigator that would increase the operative risk or confound the outcome of the clinical investigation (e.g., poorly controlled diabetes, immuno-compromised, connective tissue disease, uncontrolled ocular hypertension, glaucomatous changes on the optic nerve, chronic iritis/uveitis, retinal vessel disease, etc.) or where healing processes are compromised; 13. Diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) or known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the clinical investigation (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.); 14. Conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudo exfoliation, trauma, or posterior capsule defects; 15. Use of systemic or ocular medications that may affect vision; 16. Serious dry eye symptoms that could lead to refractive changes/fluctuations and to significant subjects’ complaints; 17. Prior or current use of any medication (e.g., a1-blocker such as tamsulosin or silodosin) likely, in the opinion of the investigator, to cause poor dilation or lack of adequate iris structure or floppy iris syndrome to perform standard cataract surgery; 18. Inability to focus, fixate or maintain binocular vision for prolonged periods of time (e.g., due to strabismus, nystagmus, Parkinson disease, etc.); 19. Pregnant, plan to become pregnant, lactating or have another condition associated with the fluctuation of hormones that could lead to significant refractive changes; 20. Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects achieving 0.3 LogMAR monocular Distance Corrected Near Visual Acuity(DCNVA) at 40cm at 6-month visit (150-210 days postoperative) for the study eye.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Monocular DCNVA (40cm), Distance Corrected Intermediate Visual Acuity(DCIVA )(66cm) and Corrected Distance Visual Acuity(CDVA) (4m) at postoperative 1 day, 1 week, 1/3/6/12 month visit;Monocular DCNVA (33cm) at postoperative 6/12 month visit;Monocular Monocular Uncorrected Near Visual Acuity(UNVA) (40cm), Uncorrected Intermediate Visual Acuity(UIVA) (66cm) and Uncorrected Distance Visual Acuity(UDVA) (4m) at postoperative 1 day, 1 week, 1/3/6/12 month visit.; | — |
Countries
China
Contacts
Public ContactMingzhi Zhang
Joint Shantou International Eye Center (JSIEC) of Shantou University
Outcome results
None listed