Safety and Effectiveness of an Hydrophilic Acrylic Intraocular Lens

Carl Zeiss Meditec AG (Industry)
Overall Status
Completed ID

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: 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 Design

Study Type:
Actual Enrollment :
328 participants
Observational Model:
Time Perspective:
Official Title:
Retro-prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens (509)
Actual Study Start Date :
Aug 31, 2021
Actual Primary Completion Date :
Apr 1, 2022
Actual Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Monofocal IOL

Other: monofocal lens
not applicable as patients are already implanted with the monofocal intraocular lens

Outcome Measures

Primary Outcome Measures

  1. Visual acuity [12 to 24 months after the implantation]

    Visual acuity at far distance

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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 device 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

Contacts and Locations


Site City State Country Postal Code
1 Hopital Desgenettes Lyon France 69275

Sponsors and Collaborators

  • Carl Zeiss Meditec AG


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Carl Zeiss Meditec AG Identifier:
Other Study ID Numbers:
  • ASPHINA 509 BER-401-20
First Posted:
Mar 9, 2021
Last Update Posted:
May 10, 2022
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2022