Eyhance Autorefraction Study

Repeatability of Post-operative Refraction in Patients With a Novel CE Marked Monofocal Intraocular Lens

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.

Study Overview

• Status: Unknown
• Conditions: Cataract Senile
• Intervention / Treatment: Other: Auto and Subjective Refraction

Detailed Description

This a prospective observational study that would include pseudophakic patients that have undergone cataract surgery 2 to 12 months prior. A written informed consent will be obtained from each patient. Patients with ICB00 or ZCB00 implanted lenses will be included.

Autorefraction measurements will be performed consecutively, each patient will be measured three times with each device. Two independent observers will perform subjective refraction and will be masked to the autorefraction outcome.

We would like to include 50 eyes with ICB00 and 50 eyes with ZCB00 lens implanted. For the estimation of sample size, we used data from Wang et al. (Wang L, Misra M, Palikaris IG, Koch DD. J Cataract Refract Surg 2002; 28: 276-282) that compared the refractive outcome of pseudophakic eyes and determined a mean spherical equivalent of -0.76 + 0.96 D for group I and -0.44 + 1.13 for group II, thus leading to an effect size of 0.2. The effect size was used for ANOVA test for repeated measurements within factor, with alpha < 0.05, power of 80% and a correlation of 0.5 between the two groups gave us an estimated of sample size of 42 patient. To allow patient drop out a number of 50 eyes will be included per lens group (in total 100 eyes).

When different lenses are implanted (one eye received ZCB00 and the other Eyhance), than both eyes of the patient will be included.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oliver Findl, Prof., MD; Phone Number: +43 1 91021 57564; Email: office@viros.at
• Study Contact Backup: Name: Nino Hirnschall, MD, PhD; Phone Number: +43 1 91021 57564; Email: nino.hirnschall@googlemail.com

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Recruiting
    • Hanusch Hospital, Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 21 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: visual acuity and refractive outcome for Tecnis Eyhance; Evaluation the comparability and reproducibility of different refraction methods in patients implanted with Eyhance lens	Other: Auto and Subjective Refraction; All patients will be measured with three autorefractometers and two independent observes will perform subjective refraction
Other: visual acuity and refractive outcome for Tecnis ZCB00; Evaluation the comparability and reproducibility of different refraction methods in patients implanted with ZCB00 lens	Other: Auto and Subjective Refraction; All patients will be measured with three autorefractometers and two independent observes will perform subjective refraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reproducibility of different refraction methods	2-12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparability between the devices (autorefractometers)	2-12 months

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 3, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Eyhance Autorefraction study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No