Long Term Observation of Patient Satisfaction Post INTRACOR Treatment Based on Patient Perception and Diagnostic Data
NCT ID: NCT01164358
Last Updated: 2013-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
105 participants
OBSERVATIONAL
2010-07-31
2013-10-31
Brief Summary
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The hypothesis of the study is that patients after an INTRACOR treatment are satisfied in the long term.
Detailed Description
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The hypothesis of the study is that patients after a INTRACOR treatment are satisfied in the long term.
By 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.
Within 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.
The 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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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study arm I
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"
No interventions assigned to this group
study arm II
patients who have been enrolled in the previous study "Intrastromal Presbyopia Correction by Means of Femtosecond Laser (study # 0905)"
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients must have read, understood and signed the Patient Information
* Patients are willing and able to return for follow-up examinations
* 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)"
Exclusion Criteria
* Patients who are pregnant or are lactating
* Patients who are participating in another ophthalmological clinical study except "Intrastromal Presbyopia Correction by Means of Femtosecond Laser (study # 0905)"
* severe sick people who cannot give any information on their visual acuity
18 Years
ALL
No
Sponsors
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Technolas Perfect Vision GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Mike P. Holzer, Prof. Dr. med
Role: PRINCIPAL_INVESTIGATOR
University of Heidelberg, department Ophthalmology
Locations
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University of Heidelberg, department Ophthamology
Heidelberg, Baden-Wurttemberg, Germany
FreeVis LASIK Center Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany
Augenklinik am Marienplatz AG & Co. KG
Munich, Bavaria, Germany
ye-clinic for Refractive and Ophthalmo-Surgery, EJK Niederrhein
Duisburg, North Rhine-Westphalia, Germany
Countries
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References
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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.
Other Identifiers
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1002
Identifier Type: -
Identifier Source: org_study_id