Health Condition 1: H270- Aphakia
Conditions
Interventions
Intervention1: CT ASPHINA 509M/MP: The intraocular lens CT ASPHINA 509M/MP is intended for implantation in the capsular bag to replace the human crystalline lens
Intervention2: ASPHINA 509 BER-401-20
Sponsors
Carl Zeiss Meditec AG
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of any gender, aged 18 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 CT ASPHINA 509M/MP (UVE material) into the capsular bag in at least one eye 4.One-year post surgery follow-up (365 days -14 days/+365 days) for the study eye at the time of the postoperative visit 5.Patient is willing and capable of providing informed consent 6.Patient is willing and capable of complying with visits and procedures as defined by this protocol
Exclusion criteria
Exclusion criteria: 1.Preoperative corrected distance visual acuity (CDVA) better than 0.3 LogMAR (0.5 decimal) or CDVA not available preoperatively 2.Preoperative documented endothelial cell count of less than 2000/mm2 (if available) 3.Any preoperative documented ocular disorder that could potentially cause a clinically significant future visual acuity loss 4.Any preoperative documented clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.) 5.Any preoperative documented clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, irregular astigmatism, clinically significant corneal membrane dystrophies, etc.) 6.Any preoperative documented clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.) 7.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 8.Any preoperative acute infection (acute ocular disease, external/ internal infection, systemic infection) 9.Any previous preoperative intraocular and corneal surgery 10.Preoperative documented uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment 11.Preoperative documented or current systemic or ocular pharmacotherapy that effects patientsâ?? vision 12.Any other preoperative documented or current pathology or condition that could be a risk for the patient according to the investigator opinion 13. Women during pregnancy and/or lactation at time of enrollment into the study 14.Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial 15.Patients whose freedom is impaired by administrative or legal order 16.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 Note-All eye-related inclusion and exclusion criteria are applicable to the study eye only. If the non-study eye does not fulfil all criteria, the patient can still be enrolled into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The achievement of a monocular CDVA of 0.3 LogMAR or better, 12 to 24 months after the implantation of the CT ASPHINA 509M/MP.Timepoint: 12 to 24 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Monocular corrected visual acuity (CDVA), measured in Log-MAR at postoperative visit Monocular uncorrected distance visual acuity (UDVA), achievement of 0.3 LogMAR or better at postoperative visit subjective and objective refraction spherical power, cylinder power and axis at postoperative visitTimepoint: 12 to 24 Months;IOL status (tilt, dislocation, centration and opacity) Occurrence of PCO Occurrence of Nd:YAG capsulotomy Slit lamp examination (corneal status, cataract status, inflammatory reaction, fundus examination including macula and retina) Endothelial Cells Count (ECC) Intraocular Pressure (IOP) Occurrence and incidences of Adverse Events (AE) Need of a secondary surgery Occurrence and incidences of Device Deficiencies (DD)Timepoint: 12 to 24 Months | — |
Countries
France, India, Spain
Contacts
Public ContactDr Deepa Arora
Clinexel Life Sciences Private Limited
Outcome results
None listed