Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT01164358
Status:
COMPLETED
Last Update Posted:
2013-10-21
First Post:
2010-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long Term Observation of Patient Satisfaction Post INTRACOR Treatment Based on Patient Perception and Diagnostic Data
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-18', 'studyFirstSubmitDate': '2010-07-15', 'studyFirstSubmitQcDate': '2010-07-15', 'lastUpdatePostDateStruct': {'date': '2013-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'long term satisfaction of patients post INTRACOR treatment based on a questionnaire', 'timeFrame': '36 months', 'description': 'Satisfaction is assesed by three questions:\n\nDo you fell comfortable with the treatment result? Would you do the traetment again? Would you recommend the treatment to a relativ or a friend?\n\nIf two out of these three questions are answered with "yes" then it can be assumed that the patient is satisfied.'}], 'secondaryOutcomes': [{'measure': 'Determination if there is any correlation between patient satisfaction and subjective/objective diagnostic data.', 'timeFrame': '36 months', 'description': 'Objective: Change in topographic map Subjective: uncorrected near visual acuity, uncorrected distance visual acuity'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Presbyopia', 'INTRACOR', 'patient satisfaction', 'long term'], 'conditions': ['Presbyopia']}, 'referencesModule': {'references': [{'pmid': '26903524', 'type': 'DERIVED', 'citation': 'Thomas BC, Fitting A, Khoramnia R, Rabsilber TM, Auffarth GU, Holzer MP. Long-term outcomes of intrastromal femtosecond laser presbyopia correction: 3-year results. Br J Ophthalmol. 2016 Nov;100(11):1536-1541. doi: 10.1136/bjophthalmol-2015-307672. Epub 2016 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective, open, not randomized, unilateral multicenter eye study consisting of two study arms to observe the long term satisfaction of patients after an INTRACOR treatment. The satisfaction is determined with the help of the patient perception and the subjective / objective diagnostic data.\n\nThe hypothesis of the study is that patients after an INTRACOR treatment are satisfied in the long term.', 'detailedDescription': 'The study is divided into two study arms. The first study arm includes patients of the preceding study "Intrastromal Correction of Ametropia by Femtosecond Laser (study ISCAF), study arm 1, Presbyopia sub-group: treatment pattern 5-Rings" and the second study arm includes patients of the previous "Intrastromal Presbyopia Correction by Means of Femtosecond Laser (study # 0905)".\n\nThe hypothesis of the study is that patients after a INTRACOR treatment are satisfied in the long term.\n\nBy detailed patient information and a clarification conversation it is guaranteed that every interested and agreeing patient fulfils the inclusion criteria of this study. The quantitative measuring values of the patient perception are assessed by a questionnaire. For measuring the subjective / objective diagnostic data only certificated diagnostic devices are used. No invasive intervention in the eye will be made to change the visual acuity.\n\nWithin the scope of the study between 98 and 135 patients should be examined. 49 to 63 patient are intended for the first study arm and 49 to 72 for the second study arm.\n\nThe follow-up examinations are carried out at 12 months and/or 24 months as well as for 36 months after the INTRACOR treatment. The study end points are determined for all follow-up examinations. The aim criteria should be reached for the final examination, which is after 36 months, at the latest.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Just patients who have been already enrolled in the previous study "Intrastromal Correction of Ametropia by Femtosecond Laser (study ISCAF), study arm 1, Presbyopia sub-group: treatment pattern 5-Rings" or "Intrastromal Presbyopia Correction by Means of Femtosecond Laser (study # 0905)"', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: at least 18 years old\n* Patients must have read, understood and signed the Patient Information\n* Patients are willing and able to return for follow-up examinations\n* Patient has been already enrolled in the previous study "Intrastromal Correction of Ametropia by Femtosecond Laser (study ISCAF), study arm 1, Presbyopia sub-group: treatment pattern 5-Rings" or "Intrastromal Presbyopia Correction by Means of Femtosecond Laser (study # 0905)"\n\nExclusion Criteria:\n\n* Continual wearing of contact lenses before the follow-up examination . Patients must refrain from wearing contact lenses for at least 14 days prior to these dates\n* Patients who are pregnant or are lactating\n* Patients who are participating in another ophthalmological clinical study except "Intrastromal Presbyopia Correction by Means of Femtosecond Laser (study # 0905)"\n* severe sick people who cannot give any information on their visual acuity'}, 'identificationModule': {'nctId': 'NCT01164358', 'briefTitle': 'Long Term Observation of Patient Satisfaction Post INTRACOR Treatment Based on Patient Perception and Diagnostic Data', 'organization': {'class': 'INDUSTRY', 'fullName': 'Technolas Perfect Vision GmbH'}, 'officialTitle': 'Long Term Observation of Patient Satisfaction Post INTRACOR Treatment Based on Patient Perception and Diagnostic Data', 'orgStudyIdInfo': {'id': '1002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study arm I', 'description': 'patients who have been enrolled in the previous study "Intrastromal Correction of Ametropia by Femtosecond Laser (study ISCAF), study arm 1, Presbyopia sub-group: treatment pattern 5-Rings"'}, {'label': 'study arm II', 'description': 'patients who have been enrolled in the previous study "Intrastromal Presbyopia Correction by Means of Femtosecond Laser (study # 0905)"'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University of Heidelberg, department Ophthamology', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '68167', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'FreeVis LASIK Center Mannheim GmbH', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '80331', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Augenklinik am Marienplatz AG & Co. KG', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '47169', 'city': 'Duisburg', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'ye-clinic for Refractive and Ophthalmo-Surgery, EJK Niederrhein', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}], 'overallOfficials': [{'name': 'Mike P. Holzer, Prof. Dr. med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Heidelberg, department Ophthalmology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technolas Perfect Vision GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}