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Visual Outcomes After Presbyopic Lens Exchange (RELAX)

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ClinicalTrials.gov Identifier: NCT03790592
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Carl Zeiss Meditec AG

Study Description
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Brief Summary:
Evaluation of mean preoperative and postoperative Corrected distance visual acuity (CDVA) after Refractive Lens Exchange in presbyopic patients

Condition or disease Intervention/treatment Phase
Presbyopia Device: trifocal IOL Not Applicable

Detailed Description:
Compare preoperative and postoperative Corrected distance visual acuity

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Outcomes and Patient Satisfaction After Presbyopic Lens Exchange With a Trifocal Intraocular Lens (IOL)
Actual Study Start Date : May 14, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : April 1, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: trifocal IOL
patients implanted with a trifocal intraocular lens
 Device: trifocal IOL
intraocular lens


Outcome Measures
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Primary Outcome Measures :
  1. Corrected distance visual acuity [ Time Frame: 4 to 6 months postop ]
    preoperative and postoperative Corrected distance visual acuity will be assessed


Eligibility Criteria
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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 protocol and who has given his/her written informed consent
  2. Patients of any gender, aged 18 years or older
  3. Assured follow-up examinations
  4. Post-operative astigmatism ≤ 0.75 Diopter
  5. IOL implanted into the capsular bag with trifocal IOL in both eyes
  6. Patients who had bilateral uncomplicated presbyopic lens exchange surgery in both healthy eyes
  7. Preoperative monocular and binocular CDVA equal or better than 0.2 logMAR
  8. Normal findings in the medical history and physical examination

Exclusion Criteria:

  1. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
  2. Patients whose freedom is impaired by administrative or legal order
  3. Concurrent participation in another drug or device investigation that affects patients vision
  4. Signs of early cataract in either eye
  5. Preoperative monocular and binocular CDVA worse than 0.2 logMAR
  6. Clinically significant Posterior capsule opacification (PCO) defined as a CDVA loss of 0.2 logMAR or more in either eye
  7. Cataract of any grade
  8. Ocular disorders, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse in either eye
  9. Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, clinically significant anterior membrane dystrophies, poor pupil dilation, etc.)
  10. Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
  11. Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
  12. History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerv atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis.
  13. Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus
  14. Patient expected to require retinal laser treatment before 6 month follow-up visit
  15. Patient require refractive laser treatment / refractive laser touch-up before 6 month follow up visit
  16. Current Systemic or ocular pharmacotherapy that effects patients vision
  17. Floppy iris syndrome
  18. Monophthalmic patient
  19. Previous corneal surgery
  20. Previous use of cytotoxic drugs or total body irradiation
  21. Dementia
  22. Uncontrolled glaucoma or Intraocular pressure (IOP) higher than 24 millimeter of mercury (mmHg) under ocular hypertension treatment
  23. Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
Contacts and Locations
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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): NCT03790592


Contacts
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Contact: Estelle POINEAU +33(0)546523154 estelle.poineau@zeiss.com

Locations
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Germany
Augenzentrum Michelfeld Recruiting
Michelfeld, Germany
Contact: Augenzentrum Michelfeld         
Sponsors and Collaborators
Carl Zeiss Meditec AG
More Information
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Responsible Party: Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier: NCT03790592     History of Changes
Other Study ID Numbers: LISA tri 839MP BER-401-18
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: July 24, 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