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OpenTrials
Completed

NCT Number: NCT03839420

To Compare Early Rotation of Two Extended Depth of Focus Intraocular Lenses

To demonstrate that the Carl Zeiss Meditec (CZM) Extended depth of focus (EDOF) Intraocular lens (IOL) is superior to the competitor EDOF IOL with respect to Rotational Stability.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent
  • Patients of any gender, aged 18 or older
  • Assured follow-up examinations
  • Healthy eyes with clinically significant age related cataract requiring surgical treatment
  • Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment
  • Uni- and/or bilaterally regular corneal astigmatism ≥ 1.0 D and ≤ 3.0 D (confirmed by topography measurement)
  • Cataract density compatible with biometry measurement

Exclusion criteria

  • Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial
  • Patients whose freedom is impaired by administrative or legal order
  • Current participation in another drug or device investigation that affects patients vision
  • Ocular disorders, other than cataract, that could potentially cause future acuity loss
  • Have atonic pupil or physiologically small pupil (unable to dilate to at least 5 mm)
  • Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.)
  • Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
  • Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, Floppy iris syndrome etc.)
  • History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis
  • Pseudoexfoliation syndrome (according to investigator decision)
  • Pathologic miosis or Pharmacotherapy with miotic agent
  • Irregular astigmatism / Keratoconus
  • Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment.
  • All kind of infections (acute ocular disease, external / internal infection, systemic infection)
  • Traumatic cataract
  • Monophthalmic patient
  • Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus
  • Patient expected to require retinal laser treatment before the end of the last follow-up examination
  • Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination
  • Previous intraocular and corneal / refractive surgery
  • Current Systemic or ocular pharmacotherapy that effects patients vision (according to investigator decision)
  • Dementia
  • Previous use of cytotoxic drugs or total body irradiation within last 2 years
  • Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
  • Pregnancy and / or lactation period

Treatment and study plan

CZM IOL

Device

implantation of CZM IOL

Competitor IOL

Device

implantation of Competitor IOL

Primary outcomes

  1. IOL axis

    Time frame: Immediately after the surgery

    IOL axis will be analyzed based on images.

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec AG

Industry

Registry information

Official study title

Prospective Randomized Clinical Trial Comparing Early Rotation of Two Extended Depth of Focus Intraocular Lenses

Acronym: VENUStoric

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Feb 15, 2019
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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