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

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04387721
• Other study ID #: EC042019
• Secondary ID: 2019/65-OFT-CMT
• Status: Recruiting
• Start date: July 29, 2019
• Est. completion date: July 2021

Study information

• Verified date: May 2020
• Source: Clinica Oftalmologica TACIR
• Contact: Enrique Ordiñaga-Monreal, OD
• Phone: 934179803
• Email: e.ordinaga[@]clinicatacir.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 2021
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Cataract After
• IOL
• Visual Acuity

Intervention

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

Locations

Country	Name	City	State
Spain	Clinica Oftalmológica TACIR	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Enrique Ordiñaga-Monreal, OD, MSc

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Differences between groups	Results will be compared between groups.	3 months following cataract surgery