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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-03', 'studyFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2020-09-30', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reproducibility of different refraction methods', 'timeFrame': '2-12 months'}], 'secondaryOutcomes': [{'measure': 'Comparability between the devices (autorefractometers)', 'timeFrame': '2-12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract Senile']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAutorefraction 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.\n\nWe 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).\n\nWhen different lenses are implanted (one eye received ZCB00 and the other Eyhance), than both eyes of the patient will be included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 21 years old or above\n* Operated age-related cataract (pseudophakic patient)\n* Tecnis Eyhance ICB00 or Tecnis ZCB00 IOL implanted within 2 to 12 months prior to study related examination\n\nExclusion Criteria:\n\n* Intra- or Postoperative complication\n* patients with severe corneal pathology, severe macular degeneration, severe diabetic retinopathy, etc. that would significantly influence visual outcome\n* nystagmus or pathologies that would affect patient fixation\n* pregnancy- for women in reproductive age a pregnancy test will be performed.'}, 'identificationModule': {'nctId': 'NCT04572334', 'briefTitle': 'Eyhance Autorefraction Study', 'organization': {'class': 'OTHER', 'fullName': 'Vienna Institute for Research in Ocular Surgery'}, 'officialTitle': 'Repeatability of Post-operative Refraction in Patients With a Novel CE Marked Monofocal Intraocular Lens', 'orgStudyIdInfo': {'id': 'Eyhance Autorefraction study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'visual acuity and refractive outcome for Tecnis Eyhance', 'description': 'Evaluation the comparability and reproducibility of different refraction methods in patients implanted with Eyhance lens', 'interventionNames': ['Other: Auto and Subjective Refraction']}, {'type': 'OTHER', 'label': 'visual acuity and refractive outcome for Tecnis ZCB00', 'description': 'Evaluation the comparability and reproducibility of different refraction methods in patients implanted with ZCB00 lens', 'interventionNames': ['Other: Auto and Subjective Refraction']}], 'interventions': [{'name': 'Auto and Subjective Refraction', 'type': 'OTHER', 'description': 'All patients will be measured with three autorefractometers and two independent observes will perform subjective refraction', 'armGroupLabels': ['visual acuity and refractive outcome for Tecnis Eyhance', 'visual acuity and refractive outcome for Tecnis ZCB00']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1140', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Oliver Findl, Prof. MD', 'role': 'CONTACT', 'email': 'office@viros.at', 'phone': '+43 1 91021 57564'}], 'facility': 'Hanusch Hospital, Department of Ophthalmology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Oliver Findl, Prof., MD', 'role': 'CONTACT', 'email': 'office@viros.at', 'phone': '+43 1 91021 57564'}, {'name': 'Nino Hirnschall, MD, PhD', 'role': 'CONTACT', 'email': 'nino.hirnschall@googlemail.com', 'phone': '+43 1 91021 57564'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vienna Institute for Research in Ocular Surgery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Ophthalmology Department, and Principal Investigator', 'investigatorFullName': 'Prim. Prof. Dr. Oliver Findl, MBA', 'investigatorAffiliation': 'Vienna Institute for Research in Ocular Surgery'}}}}