Influence of Residual Astigmatism on Visual Acuity in Patients Undergoing Cataract Surgery With Trifocal Intraocular Lens Implantation

NCT ID: NCT04387721

Last Updated: 2020-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-29

Study Completion Date

2021-07-31

Brief Summary

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MAIN OBJECTIVE: To assess the influence of residual astigmatism on visual acuity in the different lens foci in patients operated on for cataracts with a trifocal intraocular lens implant.

SECONDARY OBJECTIVE: To study the influence of residual astigmatism on the visual quality of the patient in the far focus and to determine if there are differences of affectation in the two study groups.

Detailed Description

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It will be studied how small residual astigmatisms after cataract surgery degrade the visual acuity of patients in the three focal planes of trifocal IOLs. Not only VA will be studied, but also visual quality through contrast sensitivity curves.

Conditions

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Cataract After Astigmatism IOL Visual Acuity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Trifocal IOL(Finevision IOL, PhysIOL)

We will divide the sample into two groups of patients depending on the IOL implanted First group: FineVision

Kind of trifocal IOL

Intervention Type OTHER

Patients will be divided between groups based on pre-surgery corneal astigmatism. Group FineVision is made up of patients with corneal astigmatism less than 1 D. Groups FineVision Toric is made up pf patients with corneal astigmatism more than 1.25 D

Trifocal toric IOL (Finevision Toric IOL, PhysIOL)

We will divide the sample into two groups of patients depending on the IOL implanted: Second group: FineVisionToric

Kind of trifocal IOL

Intervention Type OTHER

Patients will be divided between groups based on pre-surgery corneal astigmatism. Group FineVision is made up of patients with corneal astigmatism less than 1 D. Groups FineVision Toric is made up pf patients with corneal astigmatism more than 1.25 D

Interventions

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Kind of trifocal IOL

Patients will be divided between groups based on pre-surgery corneal astigmatism. Group FineVision is made up of patients with corneal astigmatism less than 1 D. Groups FineVision Toric is made up pf patients with corneal astigmatism more than 1.25 D

Intervention Type OTHER

Other Intervention Names

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FineVision IOL FineVision Toric IOL

Eligibility Criteria

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Inclusion Criteria

* Bilateral surgery performed by the same surgeon
* IOLs implanted IOLs FineVision (MicroF) and FineVision Toric (PodFT)
* Patients with pre-surgery corneal astigmatism less than 2.5 D
* Patients whose pupillary diameter in physiological position (conditions of lower photopic pupil) not over 4 mm.

Exclusion Criteria

* Post-surgical refractive residual astigmatisms ≧ 1.55D
* Previous corneal or intraocular surgeries
* Active diseases
* Eye complications during the 3-month follow-up
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Enrique Ordiñaga-Monreal, OD, MSc

OTHER

Sponsor Role lead

Responsible Party

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Enrique Ordiñaga-Monreal, OD, MSc

Clinical Optometrist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Enrique Ordiñaga-Monreal, OD

Role: PRINCIPAL_INVESTIGATOR

Clinica Oftalmologica TACIR

Locations

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Clinica Oftalmológica TACIR

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Enrique Ordiñaga-Monreal, OD

Role: CONTACT

934179803

Facility Contacts

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Ordiñaga-Monreal Enrique, OD

Role: primary

934179803

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2019/65-OFT-CMT

Identifier Type: OTHER

Identifier Source: secondary_id

EC042019

Identifier Type: -

Identifier Source: org_study_id

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