Visual Function in Subjects Implanted With Advanced Technology Intraocular Lenses

• Conditions: Lenses, Intraocular
• Interventions: Device: Cataract surgery with bilateral implantation of the same type of intraocular lens

• Registration Number: NCT04916041
• Lead Sponsor: Clínica Rementería

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20
• Primary Completion: 2023-06-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vivity	Cataract surgery with bilateral implantation of the same type of intraocular lens	Patients who have undergone bilateral implantation of Vivity intraocular lens
Eyhance	Cataract surgery with bilateral implantation of the same type of intraocular lens	Patients who have received bilateral implantation of an Eyhance intraocular lens
Rayner Trifocal	Cataract surgery with bilateral implantation of the same type of intraocular lens	Patients who have undergone bilateral implantation of Rayner trifocal intraocular lens
EMV	Cataract surgery with bilateral implantation of the same type of intraocular lens	Patients who have undergone bilateral implantation of Vivity intraocular lens
Panoptix	Cataract surgery with bilateral implantation of the same type of intraocular lens	Patients who have undergone bilateral implantation of Panoptix intraocular lens

Primary Outcome Measures

Name	Time	Method
Intermediate binocular uncorrected visual acuity	3-9 months after cataract surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clínica Rementería; 🇪🇸 Madrid, Spain