Eyhance Autorefraction Study

NCT ID: NCT04572334

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2021-03-31

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.

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.

Conditions

Cataract Senile

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

visual acuity and refractive outcome for Tecnis Eyhance

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

Group Type: OTHER

Auto and Subjective Refraction

Intervention Type: OTHER

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

visual acuity and refractive outcome for Tecnis ZCB00

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

Group Type: OTHER

Auto and Subjective Refraction

Intervention Type: OTHER

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

Interventions

Auto and Subjective Refraction

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Head of the Ophthalmology Department, and Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hanusch Hospital, Department of Ophthalmology

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Oliver Findl, Prof., MD

Role: CONTACT

office@viros.at

+43 1 91021 57564

Nino Hirnschall, MD, PhD

Role: CONTACT

nino.hirnschall@googlemail.com

+43 1 91021 57564

Facility Contacts

Oliver Findl, Prof. MD

Role: primary

office@viros.at

+43 1 91021 57564

Other Identifiers

Eyhance Autorefraction study

Identifier Type: -

Identifier Source: org_study_id