Status:
COMPLETED
Prospective Evaluation of an Hydrophilic Acrylic Intraocular Lens
Lead Sponsor:
Carl Zeiss Meditec AG
Conditions:
Cataract Senile
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Evaluation of the clinical safety and effectiveness of an hydrophilic acrylic intraocular lens
Detailed Description
To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) and the distance-corrected near visual acuity (DCNVA) at 6 months postoperative.
Eligibility Criteria
Inclusion
- Patients of any gender, aged 18 years or older
- Patient is planned for aged-related cataract surgery and implantation of the study IOL into the capsular bag in at least one eye
- Patient is willing and capable of providing informed consent
- Patient is willing and capable of complying with visits and procedures as defined by this protocol
Exclusion
- Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)
- Endothelial cell count of less than 2000/mm2
- Ocular disorder that could potentially cause a clinically significant future visual acuity loss
- Preoperative corneal astigmatism ative corneal to be \< 1 D.
- Clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
- Clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
- Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
- Any 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
- Any acute infection (acute ocular disease, external/internal infection, systemic infection)
- Any previous intraocular and corneal surgery
- Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
- Current systemic or ocular pharmacotherapy that effects patients'vision
- Current pathology or condition that could be a risk for the patient according to the investigator opinion
- Women during pregnancy and/or lactation
- Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial
- Patients whose freedom is impaired by administrative or legal order
- 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
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2022
Estimated Enrollment :
387 Patients enrolled
Trial Details
Trial ID
NCT04907500
Start Date
June 22 2021
End Date
December 16 2022
Last Update
February 8 2023
Active Locations (1)
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1
DUO STIL SRL , Clinica Oftalmologica Medoptic
Suceava, Romania