Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-31 @ 10:43 PM
Study NCT ID:
NCT04572334
Status:
UNKNOWN
Last Update Posted:
2020-10-06
First Post:
2020-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eyhance Autorefraction Study
Sponsor:
Vienna Institute for Research in Ocular Surgery
Organization:
Study Overview
Official Title:
Repeatability of Post-operative Refraction in Patients With a Novel CE Marked Monofocal Intraocular Lens
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: