Visual Function in Subjects Implanted With Advanced Technology Intraocular Lenses

Sponsor

Clínica Rementería (Other)

Overall Status

Recruiting

CT.gov ID

NCT04916041

Collaborator

(none)

150

Enrollment

Location

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lenses, Intraocular	Device: Cataract surgery with bilateral implantation of the same type of intraocular lens

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Visual Function in Subjects Implanted With Advanced Technology Intraocular Lenses

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Intermediate binocular uncorrected visual acuity [3-9 months after cataract surgery]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Clínica Rementería

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Clínica Rementería

ClinicalTrials.gov Identifier:

NCT04916041

Other Study ID Numbers:

21/365-O_P

First Posted:

Jun 7, 2021

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Jul 20, 2022