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

NCT04387721 | Unknown DMC

• 2 other identifiers: EC0420192019/65-OFT-CMT
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract After; Astigmatism; IOL; Visual Acuity

Keywords

CSF; Contrast Sensitivity; Trifocal IOL

Outcome Measures

Primary Outcomes (2)

• Visual Acuity

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

  3 months following cataract surgery

• Contrast Sensitivity Function (CSF)

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

  3 months following cataract surgery

Secondary Outcomes (1)

• Differences between groups

  3 months following cataract surgery

Study Arms (2)

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

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

Interventions

Kind of trifocal IOL 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

Also known as: FineVision IOL, FineVision Toric IOL

Trifocal IOL(Finevision IOL, PhysIOL); Trifocal toric IOL (Finevision Toric IOL, PhysIOL)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The field in which it will carry out the study is a private medical centre. TACIR Ophthalmology clinic is located in the TEKNON Medical Center in the city of Barcelona. The study population will be the patients of the TACIR ophthalmology clinic who will be operated on cataracts and agree to take part in the study.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Enrique Ordiñaga-Monreal, OD, MSc: lead

Study Sites (1)

Clinica Oftalmológica TACIR

Barcelona, 08022, Spain

RECRUITING

MeSH Terms

Conditions

Capsule Opacification; Astigmatism

Condition Hierarchy (Ancestors)

Cataract; Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Enrique Ordiñaga-Monreal, OD

  Clinica Oftalmologica TACIR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrique Ordiñaga-Monreal, OD

CONTACT

934179803; e.ordinaga@clinicatacir.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Optometrist

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: July 29, 2019
• Primary Completion: March 1, 2020
• Study Completion: July 1, 2021
• Last Updated: May 14, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)