Eyhance Autorefraction Study

• Sponsor: Vienna Institute for Research in Ocular Surgery (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04572334
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 20.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Senile	Other: Auto and Subjective Refraction	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Repeatability of Post-operative Refraction in Patients With a Novel CE Marked Monofocal Intraocular Lens
• Anticipated Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: Mar 1, 2021
• Anticipated Study Completion Date: Mar 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Reproducibility of different refraction methods [2-12 months]

Secondary Outcome Measures

1. Comparability between the devices (autorefractometers) [2-12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanusch Hospital, Department of Ophthalmology	Vienna		Austria	1140

Sponsors and Collaborators

• Vienna Institute for Research in Ocular Surgery

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Head of the Ophthalmology Department, and Principal Investigator, Vienna Institute for Research in Ocular Surgery
• ClinicalTrials.gov Identifier: NCT04572334
• Other Study ID Numbers: Eyhance Autorefraction study
• First Posted: Oct 1, 2020
• Last Update Posted: Oct 6, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Oct 6, 2020