Evaluation of a Spherical Hydrophilic Acrylic Intraocular Lens

Retro-prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens

Evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens

Study Overview

• Status: Completed
• Conditions: Cataract Senile
• Intervention / Treatment: Device: Monofocal lens

Detailed Description

To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) at 12-24 month postoperative.

• Study Type: Observational
• Enrollment (Actual): 242

Contacts and Locations

Study Locations

• Germany
  • Rosenheim, Germany, 83022
    • Augenklinik Rosenheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with the study lens

Description

Inclusion Criteria:

• Patients of any gender, aged 18 years or older at the time of the surgery
• Patients who had an uncomplicated (no intra-operative complication) aged-related cataract surgery
• Currently implanted with the study IOL into the capsular bag in at least one eye
• One-year post surgery follow-up (365 days -14 days/+365 days) for the study eye at the time of the postoperative visit
• 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 Criteria:

• Preoperative corrected distance visual acuity (CDVA) better than 0.3 LogMAR (0.5 decimal) or CDVA not available preoperatively
• Preoperative documented endothelial cell count of less than 2000/mm2 (if available)
• Any preoperative documented ocular disorder that could potentially cause a clinically significant future visual acuity loss
• Any preoperative documented clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
• Any preoperative documented clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
• Any preoperative documented clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
• 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
• Any preoperative acute infection (acute ocular disease, external/internal infection, systemic infection)
• Any previous preoperative intraocular and corneal surgery
• Preoperative documented uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
• Preoperative documented or current systemic or ocular pharmacotherapy that effects patients' vision
• Any other preoperative documented or current pathology or condition that could be a risk for the patient according to the investigator opinion
• Women during pregnancy and/or lactation at time of enrollment into the study
• Patients unable to meet the limitations of the protocol or likely of non-cooperation 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Monofocal IOL	Device: Monofocal lens; not applicable as patients are already implanted with the monofocal lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Monocular visual acuity at far distance (4m) using sloan letters	12 to 24 months after the implantation

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Actual): April 22, 2022
• Study Completion (Actual): April 22, 2022

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: SPHERIS 209 BER-401-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No