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Evaluating Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens

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ClinicalTrials.gov Identifier: NCT03787576
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Clínica Rementería

Brief Summary:
Multifocal lens allow most patients to be spectacle-free after cataract surgery. Most studies published up-to-date have focused on visual acuity, but not on patient-reported outcomes. Since some patients with very good postoperative visual acuity report being very uncomfortable after surgery, the aim of this study is to evaluate if patient satisfaction is correlated with other outcomes, such as low-contrast visual acuity, contrast sensitivity, photic phenomena and ability to tolerate defocus. Patients who have undergone surgery with bilateral multifocal intraocular lens implantation will be carefully evaluated 3 months after surgery to try to determine the factors that correlate with patient reported outcomes as evaluated with the Catquest SF-9 questionnaire.

Condition or disease Intervention/treatment
Cataract Device: Cataract surgery

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Relationship Between Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens Implantation and Defocus Curves, Contrast Sensitivity and Photic Phenomena
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract


Intervention Details:
  • Device: Cataract surgery
    Evaluation of patient satisfaction after bilateral cataract surgery with multifocal intraocular lens implantation


Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: Three months after surgery ]
    Patient satisfaction with visual outcome three months after surgery as evaluated with the Catquest-9 questionnaire



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
Patients who have undergone bilateral cataract surgery with bilateral implantation of a multifocal intraocular lens and who are willing to participate in the study.
Criteria

Inclusion Criteria:

  • Previous bilateral cataract surgery
  • Bilateral implantation of multifocal intraocular lens

Exclusion Criteria:

  • Presence of ocular pathologies
  • Intra- or postoperative complications

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): NCT03787576


Contacts
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Contact: Inés Contreras, MD, PhD 34913083838 contreras@clinicarementeria.es

Locations
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Spain
Clínica Rementería Recruiting
Madrid, Spain, 28010
Contact: Inés Contreras       contreras@clinicarementeria.es   
Sponsors and Collaborators
Clínica Rementería
Investigators
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Principal Investigator: Inés Contreras Clinina Rementería

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Responsible Party: Clínica Rementería
ClinicalTrials.gov Identifier: NCT03787576     History of Changes
Other Study ID Numbers: 18/552-E
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Clínica Rementería:
Multifocal intraocular lens
Trifocal intraocular lens
Extended Depth of Focus Lens
Additional relevant MeSH terms:
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Cataract
Capsule Opacification
Lens Diseases
Eye Diseases