Visual Function in Subjects Implanted With Advanced Technology Intraocular Lenses

Lenses, Intraocular Clinical Trial

Official title:

Visual Function in Subjects Implanted With Advanced Technology Intraocular Lenses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04916041
• Other study ID #: 21/365-O_P
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: July 2022
• Source: Clínica Rementería
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lenses, Intraocular

Intervention

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

Locations

Country	Name	City	State
Spain	Clínica Rementería	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Clínica Rementería

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intermediate binocular uncorrected visual acuity		3-9 months after cataract surgery
Secondary	Distance binocular uncorrected visual acuity		3-9 months after cataract surgery
Secondary	Near binocular uncorrected visual acuity		3-9 months after cataract surgery
Secondary	Binocular contrast sensitivity		3-9 months after cataract surgery
Secondary	Halo perception		3-9 months after cataract surgery
Secondary	Self-reported visual function questionnaires		3-9 months after cataract surgery