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

• Conditions: IOL; Astigmatism; Cataract After; Visual Acuity
• Interventions: Other: Kind of trifocal IOL

• Registration Number: NCT04387721
• Lead Sponsor: Enrique Ordiñaga-Monreal, OD, MSc

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.

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 Timeline

• Study Start: 2019-07-29
• Primary Completion: 2020-03-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-11
• Last Update Submitted: 2020-05-11
• Study First Posted: 2020-05-14
• Last Update Posted: 2020-05-14
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trifocal IOL(Finevision IOL, PhysIOL)	Kind of trifocal IOL	We will divide the sample into two groups of patients depending on the IOL implanted First group: FineVision
Trifocal toric IOL (Finevision Toric IOL, PhysIOL)	Kind of trifocal IOL	We will divide the sample into two groups of patients depending on the IOL implanted: Second group: FineVisionToric

Primary Outcome Measures

Name	Time	Method
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
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

Name	Time	Method
Differences between groups	3 months following cataract surgery	Results will be compared between groups.

Trial Locations

Locations (1)

Clinica Oftalmológica TACIR; 🇪🇸 Barcelona, Spain