NCT03224728

Brief Summary

Purpose: To compare the effect of spherical aberration on optical quality in eyes with two different aspherical intraocular lenses Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes an aberration-free aspherical IOL (Aspira-aA; Human Optics) or an aberration-correcting aspherical IOL (Tecnis ZCB00; Abott Medical Optics) were randomly implanted. Three months after surgery visual acuity, contrast sensitivity, wavefront measurements with iTrace as well as tilt and decentration measurements with Visante anterior segment OCT were performed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

9 months

First QC Date

July 14, 2017

Last Update Submit

July 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Modulation transfer function (MTF) at 3 months after surgery

    3 months

Study Arms (1)

2 different Intraocular lenses

2 different intraocular lenses were compared

Device: intraocular lens

Interventions

2 different Intraocular lenses

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men and women between 50 and 85 years with age related cataract

You may qualify if:

  • Bilateral age-related cataract
  • Potential postoperative visual acuity of 1.0 Snellen
  • No relevant ocular pathology other than cataract
  • Written informed consent to surgery and participation in the study

You may not qualify if:

  • Amblyopia, diabetic retinopathy, uveitis or other relevant ophthalmic diseases
  • Optical media disturbances due to: corneal and vitreal opacity, PEX
  • Preceding ocular trauma or ocular surgery within 6 months
  • Inability to cooperate
  • Pregnancy (a pregnancy test will be performed preoperatively in women of reproductive age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lasta M, Mihaltz K, Kovacs I, Vecsei-Marlovits PV. Effect of Spherical Aberration on the Optical Quality after Implantation of Two Different Aspherical Intraocular Lenses. J Ophthalmol. 2017;2017:8039719. doi: 10.1155/2017/8039719. Epub 2017 Aug 16.

MeSH Terms

Conditions

Cataract

Interventions

Lenses, Intraocular

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and SuppliesProstheses and Implants

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 21, 2017

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

July 21, 2017

Record last verified: 2017-07