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To Compare Early Rotation of Two Extended Depth of Focus Intraocular Lenses (VENUStoric)

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ClinicalTrials.gov Identifier: NCT03839420
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Carl Zeiss Meditec AG

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cataract Device: CZM IOL Device: Competitor IOL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: comparative randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Clinical Trial Comparing Early Rotation of Two Extended Depth of Focus Intraocular Lenses
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: CZM IOL Device: CZM IOL
implantation of CZM IOL

Active Comparator: Competitor IOL Device: Competitor IOL
implantation of Competitor IOL




Primary Outcome Measures :
  1. IOL axis [ Time Frame: Immediately after the surgery ]
    IOL axis will be analyzed based on images.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

8. Cataract density compatible with biometry measurement

Exclusion Criteria:

  1. Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial
  2. Patients whose freedom is impaired by administrative or legal order
  3. Current participation in another drug or device investigation that affects patients vision
  4. Ocular disorders, other than cataract, that could potentially cause future acuity loss
  5. Have atonic pupil or physiologically small pupil (unable to dilate to at least 5 mm)
  6. Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.)
  7. Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
  8. Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, Floppy iris syndrome etc.)
  9. 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
  10. Pseudoexfoliation syndrome (according to investigator decision)
  11. Pathologic miosis or Pharmacotherapy with miotic agent
  12. Irregular astigmatism / Keratoconus
  13. Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment.
  14. All kind of infections (acute ocular disease, external / internal infection, systemic infection)
  15. Traumatic cataract
  16. Monophthalmic patient
  17. Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus
  18. Patient expected to require retinal laser treatment before the end of the last follow-up examination
  19. Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination
  20. Previous intraocular and corneal / refractive surgery
  21. Current Systemic or ocular pharmacotherapy that effects patients vision (according to investigator decision)
  22. Dementia
  23. Previous use of cytotoxic drugs or total body irradiation within last 2 years
  24. Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
  25. Pregnancy and / or lactation period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839420


Contacts
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Contact: Estelle Poineau 0546523154 estelle.poineau@zeiss.com

Sponsors and Collaborators
Carl Zeiss Meditec AG

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Responsible Party: Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier: NCT03839420     History of Changes
Other Study ID Numbers: 929MP BER-401-18
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases