Health Condition 1: H270- Aphakia
Conditions
Interventions
Intervention1: AT LISA tri 839MP: AT LISA tri 839MPis intended for implantation in the capsular bag to replace the human crystalline
lens.
Intervention2: AT LISA tri 839MP
: Mfg By:
Carl Zeiss Medite
Sponsors
Carl Zeiss Meditec AG
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of any gender, aged 45 years or older at the time of the surgery 2. Patients who had an uncomplicated (no intra-operative complication) aged-related cataract surgery 3. Currently implanted with an IOL model AT LISA tri 839MP (UVE material) into the capsular bag in at least one eye 4. Preoperative corrected distance visual acuity (CDVA) equal or worse than 0.3 logMAR (0.5 decimal) or dysfunctional lens syndrome with significant impact on patient vision 5. One-year post surgery follow-up (365 days -14 days/+730 days) for the study eye at the time of the postoperative visit 6. Patient is willing and capable of providing informed consent 7. Patient is willing and capable of complying with visits and procedures as defined by this protocol
Exclusion criteria
Exclusion criteria: 1.Preoperative documented endothelial cell count of less than 2000/mm2 (if available) 2. Any preoperative documented ocular disorder that could potentially cause a clinically significant future visual acuity loss 3. Any preoperative documented clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.) 4. Any preoperative documented clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies) 5. Any preoperative documented clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.) 6.Any preoperative documented history of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy, optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis 7. Any preoperative acute infection (acute ocular disease, external/internal infection, systemic infection) 8. Any previous preoperative intraocular and corneal surgery 9. Preoperative documented uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment 10. Preoperative documented or current systemic or ocular pharmacotherapy that effects patientsâ?? vision 11. Any other preoperative documented or current pathology or condition that could be a risk for the patient according to the investigator opinion 12. Women during pregnancy and/or lactation at time of enrollment into the study 13. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial 14. Patients whose freedom is impaired by administrative or legal order 15. Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patientsâ?? vision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The achievement of a monocular CDVA of 0.3 LogMAR or better, measured at 400cm, 12 to 36 months after the implantation of the AT LISA tri 839MP. 2.The achievement of a monocular DCIVA of 0.3 LogMAR or better, measured at 80cm, 12 to 36 months after the implantation of the AT LISA tri 839MP (UVE material) or 3 months after implantation of the AT LISA tri 839MP (UV material). 3. The achievement of a monocular DCNVA of 0.3 LogMAR or better, measured at 40cm, 12 to 36 months after the implantation of the AT LISA tri 839MP (UVE material) or 3 months after implantation of the AT LISA tri 839MP (UV material).Timepoint: 12 to 36 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Monocular corrected visual acuity (CDVA), measured in LogMAR at postoperative visit 2.Monocular distance-corrected intermediate visual acuity (DCIVA), measured in LogMAR at postoperative visit 3.Monocular distance-corrected near visual acuity (DCNVA), measured in LogMAR at postoperative visit 4.Monocular uncorrected distance visual acuity (UDVA), achievement of 0.3 LogMAR or better at postoperative visit 5. Monocular uncorrected intermediate visual acuity (UIVA), achievement of 0.3 LogMAR or better at postoperative visit 6. Monocular uncorrected near visual acuity (UNVA), achievement of 0.3 LogMAR or better at postoperative visit 7. Subjective and objective refraction, spherical power, cylinder power and axis at postoperative visit 8.Contrast sensitivity under photopic with glare and mesopic conditions with and without glare 9.Subjective visual qualityTimepoint: 12 to 36 Months;Safety Endpoints- 1.IOL status (tilt, dislocation, centration and opacity) 2.Occurrence of PCO Occurrence of Nd:YAG capsulotomy 3.Slit lamp examination (corneal status, cataract status,inflammatory reaction, fundus examination ) 4.Endothelial Cells Count (ECC) 5.Intraocular Pressure (IOP) 6.Occurrence and incidences of Adverse Events (AE) 7.Need of a secondary surgery 8.Occurrence and incidences of Device Deficiencies (DD)Timepoint: 12 to 36 Months | — |
Countries
Austria, Czech Republic, Germany, India, Poland, Slovakia, Spain
Contacts
Public ContactDr Deepa Arora
Clinexel Life Sciences Private Limited
Outcome results
None listed