Evaluating Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens

NCT03787576 | Completed FDA Device

• 1 other identifier: 18/552-E
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Multifocal intraocular lens; Trifocal intraocular lens; Extended Depth of Focus Lens

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

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

  Three months after surgery

Interventions

Cataract surgery DEVICE

Evaluation of patient satisfaction after bilateral cataract surgery with multifocal intraocular lens implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Presence of ocular pathologies
• Intra- or postoperative complications

Sponsors & Collaborators

• Clínica Rementería: lead

Study Sites (1)

Clínica Rementería

Madrid, 28010, Spain

Location

Related Publications (1)

• Rementeria-Capelo LA, Contreras I, Garcia-Perez JL, Carrillo V, Gros-Otero J, Ruiz-Alcocer J. Tolerance to Residual Refractive Errors After Trifocal and Trifocal Toric Intraocular Lens Implantation. Eye Contact Lens. 2021 Apr 1;47(4):213-218. doi: 10.1097/ICL.0000000000000726.

  PMID: 33323876 RESULT

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Inés Contreras

  Clinina Rementería

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2018
• First Posted: December 26, 2018
• Study Start: February 1, 2019
• Primary Completion: December 23, 2020
• Study Completion: December 23, 2020
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

ES (1)