None listed
Conditions
Brief summary
The purpose of this clinical investigation is to confirm the clinical performance and safety of the HOYA Vivinex™ Gemetric™ Plus Toric preloaded IOLs versus comparator Alcon Acrysof® IQ PanOptix® Toric Trifocal IOLs. The medical indication is the implantation with a Vivinex™ Gemetric™ Plus Toric preloaded IOL for visual correction of aphakia and pre-existing corneal astigmatism after implantation into the capsular bag in adult patients who desire near, intermediate and distance vision with increased spectacle independence. The primary hypothesis is based on the primary performance endpoint, that is the percentage of patients achieving 0.3 LogMAR monocular distance corrected near visual acuity (DCNVA) when measured at 40cm at 6 month visit among subjects implanted with the HOYA Vivinex™ Gemetric™ Plus Toric preloaded IOLs will be non-inferior to that of subjects implanted with the Alcon Acrysof® IQ PanOptix® Toric Trifocal IOLs.
Interventions
Investigational device: HOYA Vivinex™ Gemetric™ Plus Toric preloaded IOL, Model XY1-GPT2, XY1-GPT3, XY1-GPT4, XY1-GPT5, XY1-GPT6.
The investigational devices will be used in the proposed clinical investigation according to the instructions for use. The IOL is indicated for the visual correction of aphakia and pre-existing corneal astigmatism after implantation in the capsular bag in adult patients.
The IOL is indicated for use in adult cataract patient only.
The implantation of the IOL will be
Investigational device: HOYA Vivinex™ Gemetric™ Plus Toric preloaded IOL, Model XY1-GPT2, XY1-GPT3, XY1-GPT4, XY1-GPT5, XY1-GPT6. The investigational devices will be used in the proposed clinical investigation according to the instructions for use. The IOL is indicated for the visual correction of aphakia and pre-existing corneal astigmatism after implantation in the capsular bag in adult patients. The IOL is indicated for use in adult cataract patient only. The implantation of the IOL will be at the same time as the cataract surgery. Subjects will be implanted monocularly with the investigational or comparator lens in the study eye. The eligible eye will be the study eye. Should both eyes be eligible, the study eye will be the right eye (OD). However, any planned cataract surgery required for fellow eye will need to be done at least 2 weeks after and preferably within 3 months of the study eye surgery. No study specific procedure on fellow eye except for recording IOL information (name, manufacturer, mono-/bi-/multi-focal/others) and surgery timing for the fellow eyes in eCRF, if applicable. Ophthalmic surgeons who have completed a residency in ophthalmology or its documented equivalent and are licensed to practice medicine and perform surgery at an investigative site will administer the IOL. Investigators for this clinical trial will be selected from surgeons who are experienced in small-incision phacoemulsification and IOL implantation in cataract patients and having experience with HOYA or similar preloaded IOLs. Power range of the lens models: Spherical power: +10.00D to +30.00D (in 0.50 D increments) Addition Power: +3.50D (near), +1.75D (intermediate) Cylinder Power (IOL Plane): XY1-GPT2: 1.00D, XY1-GPT3 to XY1-GPT6: 1.50D to 3.75D (0.75D step) The investigational device will be implanted into the capsular bag of eye and remain there. Participants will be followed-up for 12 months to demonstrate clinical performance, effectiveness and safety.
Sponsors
HOYA Medical Singapore Pte. Ltd.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Participants shall not be/ not have: 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. Lentodonesis2 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 not equal to 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 daily-wear 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 pseudoexfoliation, 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
Outcome results
None listed