Clinical trial NCT04545671: Evaluation of a Trifocal Lens
Official title: Retro-prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Senile
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2020-09-11
Enrollment: 389
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with the study lens IOLs

Brief summary: Evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens

Detailed description: To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA), the distance-corrected intermediate visual acuity (DCIVA) and the distance-corrected near visual acuity (DCNVA) at 12-24 month postoperative.

Eligibility 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 the study lens 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:

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, or irregular astigmatism, clinically significant corneal membrane dystrophies)
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 patients' 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 patients' vision

Primary outcomes:
measure: Visual acuity
timeFrame: 12 to 24 months after the implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Michelfeld
country: Germany
facility: Augencentrum Michelfield
state: Baden-Württemberg
Study officials:
References: