Visual Function in Subjects Implanted With Advanced Technology Intraocular Lenses

NCT04916041 | Unknown FDA Device

• 1 other identifier: 21/365-O_P
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Lenses, Intraocular

Outcome Measures

Primary Outcomes (1)

• Intermediate binocular uncorrected visual acuity

  3-9 months after cataract surgery

Secondary Outcomes (5)

• 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

Study Arms (5)

Vivity

Patients who have undergone bilateral implantation of Vivity intraocular lens

Device: 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

EMV

Patients who have undergone bilateral implantation of Vivity intraocular lens

Device: 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

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

Interventions

Cataract surgery with bilateral implantation of the same type of intraocular lens DEVICE

Cataract surgery with bilateral implantation of the same type of intraocular lens

EMV; Eyhance; Panoptix; Rayner Trifocal; Vivity

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 between three and nine months prior to study procedures, with bilateral implantation of one of the intraocular lens models included in the study

You may not qualify if:

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

Sponsors & Collaborators

• Clínica Rementería: lead

Study Sites (1)

Clínica Rementería

Madrid, 28010, Spain

RECRUITING

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 7, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)