Visual Function in Subjects Implanted With Advanced Technology Intraocular Lenses

Multiple intraocular lens are nowadays available for implantation after cataract surgery. They use different technology to try to improve patient spectacle independence. It is necessary to better characterise the performence of each type of lens, as well as to define how they are affected by residual refractive errors. The purpose of this study is to evaluate visual function in patients implanted with different lenses (advanced monofocals, trifocals) in order to be able to recommend the best type of lens for each patient.

Study Overview

• Status: Recruiting
• Conditions: Lenses, Intraocular
• Intervention / Treatment: Device: Cataract surgery with bilateral implantation of the same type of intraocular lens

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28010
    • Recruiting
    • Clinica Rementeria
    • Contact: Inés Contreras; Phone Number: 34913080808; Email: contreras@clinicarementeria.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone bilateral cataract surgery between three and nine months prior to study procedures, with bilateral implantation of one of the intraocular lens models included in the study

Description

Inclusion Criteria: Bilateral cataract surgery Bilateral implantation of one of the intraocular lens models included in the study

Exclusion Criteria:

Intrasurgical complications Postsurgical complications Ophthalmological disease that limits visual potential as estimated by investigator

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vivity; Patients who have undergone bilateral implantation of Vivity intraocular lens	Device: Cataract surgery with bilateral implantation of the same type of intraocular lens; Cataract surgery with bilateral implantation of the same type of intraocular lens
Eyhance; Patients who have received bilateral implantation of an Eyhance intraocular lens	Device: Cataract surgery with bilateral implantation of the same type of intraocular lens; Cataract surgery with bilateral implantation of the same type of intraocular lens
EMV; Patients who have undergone bilateral implantation of Vivity intraocular lens	Device: Cataract surgery with bilateral implantation of the same type of intraocular lens; Cataract surgery with bilateral implantation of the same type of intraocular lens
Panoptix; Patients who have undergone bilateral implantation of Panoptix intraocular lens	Device: Cataract surgery with bilateral implantation of the same type of intraocular lens; Cataract surgery with bilateral implantation of the same type of intraocular lens
Rayner Trifocal; Patients who have undergone bilateral implantation of Rayner trifocal intraocular lens	Device: Cataract surgery with bilateral implantation of the same type of intraocular lens; Cataract surgery with bilateral implantation of the same type of intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intermediate binocular uncorrected visual acuity	3-9 months after cataract surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Distance binocular uncorrected visual acuity	3-9 months after cataract surgery
Near binocular uncorrected visual acuity	3-9 months after cataract surgery
Binocular contrast sensitivity	3-9 months after cataract surgery
Halo perception	3-9 months after cataract surgery
Self-reported visual function questionnaires	3-9 months after cataract surgery

Collaborators and Investigators

• Sponsor: Clínica Rementería

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 21/365-O_P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No