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Compare Preoperative Visual Outcomes Obtained With the VirtIOL Device With Postoperative Results in PRELEX Patients.

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ClinicalTrials.gov Identifier: NCT04037631
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Carl Zeiss Meditec AG

Brief Summary:
Evaluation of preoperative corrected distance visual acuity (CDVA) obtained with VirtIOL device compared to postoperative CDVA.

Condition or disease Intervention/treatment
Presbyopia Device: AT LISA tri 839MP

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Clinical Study to Compare Preoperative Visual Performance Criteria Obtained With the VirtIOL Device With Postoperative Results in PRELEX Patients.
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Group/Cohort Intervention/treatment
PRELEX Device: AT LISA tri 839MP
Implantation of AT LISA tri 839MP intraocular lens in one eye




Primary Outcome Measures :
  1. Corrected distance visual acuity (CDVA) [ Time Frame: 3 months after surgery ]
    Evaluation of preoperative CDVA obtained with VirtIOL device compared to postoperative CDVA.



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
Sampling Method:   Non-Probability Sample
Study Population
Presbyopic patients
Criteria

Inclusion Criteria:

  • Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent
  • Patients of any gender, aged 18 years to open age
  • Assured follow-up examinations
  • Corrected Distance Visual Acuity (CDVA) ≤ 0.1 logMar
  • Astigmatism ≤ 0.75 diopter
  • Calculated IOL power within the available diopter range
  • Normal findings in the medical history and physical examination
  • Healthy eyes without clinically significant age-related cataract
  • Biometry measurement with the IOLMaster evaluation

    -Exclusion Criteria:

  • 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
  • Concurrent participation in another drug or device investigation
  • Signs of early cataract in eye which is to be investigated
  • Monophthalmic patient
  • Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.10 logMAR (best-corrected) or worse in eye which is to be investigated
  • Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
  • Have atonic pupil or physiologically small pupil (unable to dilate to at least 5mm)
  • Intolerance to or contraindication to cycloplegica, e.g. due to narrow angle of the anterior ocular chamber
  • Subjects, who are unable to focus for a longer time, e.g. strabismus, nystagmus
  • Patient expected to require retinal laser treatment before the end of the last follow-up
  • Patient require refractive laser treatment / refractive laser touch-up before the end of the last follow-up
  • Floppy iris syndrome
  • Diabetic retinopathy
  • Aniridia
  • Microphthalmus
  • Amblyopia
  • Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders);
  • Previous intraocular and corneal surgery
  • Any type of corneal disorder
  • Dementia
  • Pseudoexfoliation syndrome (PEX)
  • Glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
  • Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient.
  • Pregnancy and/or lactation

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): NCT04037631


Contacts
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Contact: Gergana Fulle +49308540010 clinicalstudies.meditec.sur@zeiss.com

Locations
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Germany
Internationale Innovative Ophthalmologie Recruiting
Düsseldorf, Germany, 40549
Contact: Hakan Kaymak    0211 586757-0      
Sponsors and Collaborators
Carl Zeiss Meditec AG

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Responsible Party: Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier: NCT04037631     History of Changes
Other Study ID Numbers: AT-LISA-tri 839MP BER-401-17
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 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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Presbyopia
Refractive Errors
Eye Diseases