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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

Tracking Information
First Submitted Date December 23, 2018
First Posted Date December 25, 2018
Last Update Posted Date May 7, 2019
Actual Study Start Date February 1, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 23, 2018)
Patient satisfaction [ Time Frame: Three months after surgery ]
Patient satisfaction with visual outcome three months after surgery as evaluated with the Catquest-9 questionnaire
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03787576 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens
Official Title Relationship Between Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens Implantation and Defocus Curves, Contrast Sensitivity and Photic Phenomena
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Cataract
Intervention Device: Cataract surgery
Evaluation of patient satisfaction after bilateral cataract surgery with multifocal intraocular lens implantation
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 23, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Presence of ocular pathologies
  • Intra- or postoperative complications
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Inés Contreras, MD, PhD 34913083838 contreras@clinicarementeria.es
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03787576
Other Study ID Numbers 18/552-E
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Clínica Rementería
Study Sponsor Clínica Rementería
Collaborators Not Provided
Investigators
Principal Investigator: Inés Contreras Clinina Rementería
PRS Account Clínica Rementería
Verification Date May 2019