Eyhance Autorefraction Study

NCT04572334 | Unknown

• 1 other identifier: Eyhance Autorefraction study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Since 2018, the Tecnis Eyhance ICB00 lens (Johnson\&Johnson Vision, AMO Germany GmbH) was introduced, which is a monofocal IOL which has the ability of extended depth of focus improving intermediate vision without the photic phenomena specific for the multifocal IOLs. The Tecnis Eyhance ICB00 is one of our standard IOL, routinely used in our clinic. There is no single outcome measurement that can be thought of as summarizing the efficacy of an IOL, nevertheless visual acuity and refractive outcome are the most important parameters for evaluation. Aim of this study is to determine the comparability and reproducibility of different refraction methods in patients implanted with Eyhance lens and compare the outcomes with ZCB00 lens.

Conditions

Cataract Senile

Outcome Measures

Primary Outcomes (1)

• Reproducibility of different refraction methods

  2-12 months

Secondary Outcomes (1)

• Comparability between the devices (autorefractometers)

  2-12 months

Study Arms (2)

visual acuity and refractive outcome for Tecnis Eyhance

OTHER

Evaluation the comparability and reproducibility of different refraction methods in patients implanted with Eyhance lens

Other: Auto and Subjective Refraction

visual acuity and refractive outcome for Tecnis ZCB00

OTHER

Evaluation the comparability and reproducibility of different refraction methods in patients implanted with ZCB00 lens

Other: Auto and Subjective Refraction

Interventions

Auto and Subjective Refraction OTHER

All patients will be measured with three autorefractometers and two independent observes will perform subjective refraction

visual acuity and refractive outcome for Tecnis Eyhance; visual acuity and refractive outcome for Tecnis ZCB00

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or above
• Operated age-related cataract (pseudophakic patient)
• Tecnis Eyhance ICB00 or Tecnis ZCB00 IOL implanted within 2 to 12 months prior to study related examination

You may not qualify if:

• Intra- or Postoperative complication
• patients with severe corneal pathology, severe macular degeneration, severe diabetic retinopathy, etc. that would significantly influence visual outcome
• nystagmus or pathologies that would affect patient fixation
• pregnancy- for women in reproductive age a pregnancy test will be performed.

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

Hanusch Hospital, Department of Ophthalmology

Vienna, 1140, Austria

RECRUITING

Central Study Contacts

Oliver Findl, Prof., MD

CONTACT

+43 1 91021 57564; office@viros.at

Nino Hirnschall, MD, PhD

CONTACT

+43 1 91021 57564; nino.hirnschall@googlemail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Ophthalmology Department, and Principal Investigator

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 1, 2020
• Study Start: October 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)