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OpenTrials
Completed

NCT Number: NCT03172351

EDoF IOLs vs Monofocal IOL

prospective, comparative (3 arms), randomized, multicentric clinical trial

Completed

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zeiss Study Site

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 50 to 80 years;
  • Assured follow-up examinations;
  • clinically significant bilateral cataract;

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;
  • Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (corrected) or worse in either eye
  • Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
  • Pseudoexfoliations syndrome
  • Pathologic miosis or Pharmacotherapy with miotic agent
  • Keratoconus
  • Chronic or recurrent uveitis
  • Diabetic retinopathy
  • Uncontrolled glaucoma and or IOP>24mmHg
  • Choroidal hemorrhage,
  • All kind of infections (acute ocular disease, external/internal infection, systemic infection)
  • Traumatic cataract
  • Aniridia
  • Microphthalmia
  • Amblyopia
  • Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
  • Patient expected to require retinal laser treatment before the end of the 4-6 months follow-up
  • Previous intraocular and corneal surgery
  • Expected postop. astigmatism greater than 1 D
  • Any type of corneal disorder
  • Systemic or ocular pharmacotherapy, which can impact the visual acuity,
  • Former, current or foreseeable application of Tamsulosin or Silodosin (e.g. Flomax, Flomaxtra, Rapflo) ) which potentially can cause the floppy iris syndrome, insufficient dilation, or missing of appropriate iris structures which can compromise the standard procedure according to the investigator's opinion
  • Patients who are unable to fixate for longer time (e.g. strabismus, nystagmus)
  • Dementia
  • pregnancy or lactation period for female patients

Treatment and study plan

EDoF1

Device

extended depth of focus IOL - EDoF1

Monofocal

Device

Monofocal IOL

EDoF2

Device

Comparison EDoF2 IOL

Primary outcomes

  1. Defocus curve measurement

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec AG

Industry

Registry information

Official study title

Prospective Randomized Clinical Trial Comparing Extended Depth of Focus Intraocular Lenses With a Monofocal Intraocular Lens

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 1, 2017
Registry last updated
Jul 16, 2020

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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