NCT04274088

Brief Summary

Purpose: to evaluate the effect of visual axis positioning on the optical performance of the Tecnis MIOL and the Diff-aA MIOL.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

February 14, 2020

Last Update Submit

February 19, 2020

Conditions

IOL, Cataract

Keywords

multifocal IOL, optical quality, angle alpha

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    Schnellen VA

    6 Month

Study Arms (2)

Tecnis;

Patients who received the Tecnis multifocal IOL.

Procedure: Cataract surgery

Diffractiva

Patients who received the Diffractiva multifocal IOL.

Procedure: Cataract surgery

Interventions

Cataract surgeryPROCEDURE

Phacoemulsification surgery

DiffractivaTecnis;

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients of the clinic

You may qualify if:

  • corneal astigmatism less than 1 diopter

You may not qualify if:

  • ocular pathology others than cataract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mihaltz K, Vecsei-Marlovits PV. The impact of visual axis position on the optical quality after implantation of multifocal intraocular lenses with different asphericity values. Graefes Arch Clin Exp Ophthalmol. 2021 Mar;259(3):673-683. doi: 10.1007/s00417-020-05052-5. Epub 2021 Jan 20.

    PMID: 33471202DERIVED

MeSH Terms

Conditions

Intraocular LymphomaCataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsEye NeoplasmsNeoplasms by SiteLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Resident, MD, PhD

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 18, 2020

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2018

Last Updated

February 21, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share