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

Sponsor
Enrique Ordiñaga-Monreal, OD, MSc (Other)
Overall Status
Unknown status
CT.gov ID
NCT04387721
Collaborator
(none)
48
Enrollment
1
Location
23.1
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Kind of trifocal IOL

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
48 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Influence of Residual Astigmatism on Visual Acuity in Patients Undergoing Cataract Surgery With Trifocal Intraocular Lens Implantation
Actual Study Start Date :
Jul 29, 2019
Actual Primary Completion Date :
Mar 1, 2020
Anticipated Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Trifocal IOL(Finevision IOL, PhysIOL)

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

Other: 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
Other Names:
  • FineVision IOL
  • FineVision Toric IOL

    		•
    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

    Other: 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
    Other Names:
  • FineVision IOL
  • FineVision Toric IOL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual Acuity [3 months following cataract surgery]

      Visual acuity will be measured at distance, intermediate distance (67 cm) and near (40 cm). Visual acuities will be obtained with logarithmic notation

    2. Contrast Sensitivity Function (CSF) [3 months following cataract surgery]

      Contrast sensitivity will be measured at far, intermediate distance (67 cm) and near (40 cm).

    Secondary Outcome Measures

    1. Differences between groups [3 months following cataract surgery]

      Results will be compared between groups.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinica Oftalmológica TACIR Barcelona Spain 08022

    Sponsors and Collaborators

    • Enrique Ordiñaga-Monreal, OD, MSc

    Investigators

    • Principal Investigator: Enrique Ordiñaga-Monreal, OD, Clinica Oftalmologica TACIR

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Enrique Ordiñaga-Monreal, OD, MSc, Clinical Optometrist, Clinica Oftalmologica TACIR
    ClinicalTrials.gov Identifier:
    NCT04387721
    Other Study ID Numbers:
    • EC042019
    • 2019/65-OFT-CMT
    First Posted:
    May 14, 2020
    Last Update Posted:
    May 14, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Enrique Ordiñaga-Monreal, OD, MSc, Clinical Optometrist, Clinica Oftalmologica TACIR
    CSF
    Contrast Sensitivity
    Trifocal IOL
    Additional relevant MeSH terms:
    Cataract
    Astigmatism

    Study Results

    No Results Posted as of May 14, 2020