Evaluating Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens

Sponsor
Clínica Rementería (Other)
Overall Status
Completed
CT.gov ID
NCT03787576
Collaborator
(none)
100
1
22.7
4.4

Study Details

Study Description

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 Phase
  • Device: Cataract surgery

Study Design

Study Type:
Observational
Actual 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 :
Feb 1, 2019
Actual Primary Completion Date :
Dec 23, 2020
Actual Study Completion Date :
Dec 23, 2020

Outcome Measures

Primary Outcome Measures

  1. Patient satisfaction [Three months after surgery]

    Patient satisfaction with visual outcome three months after surgery as evaluated with the Catquest-9 questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Previous bilateral cataract surgery

  • Bilateral implantation of multifocal intraocular lens

Exclusion Criteria:
  • Presence of ocular pathologies

  • Intra- or postoperative complications

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clínica Rementería Madrid Spain 28010

Sponsors and Collaborators

  • Clínica Rementería

Investigators

  • Principal Investigator: Inés Contreras, Clinina Rementería

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clínica Rementería
ClinicalTrials.gov Identifier:
NCT03787576
Other Study ID Numbers:
  • 18/552-E
First Posted:
Dec 26, 2018
Last Update Posted:
Jan 29, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Clínica Rementería
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 29, 2021