Long Term Observation of Patient Satisfaction Post INTRACOR Treatment Based on Patient Perception and Diagnostic Data
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.
The hypothesis of the study is that patients after an INTRACOR treatment are satisfied in the long term.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Long Term Observation of Patient Satisfaction Post INTRACOR Treatment Based on Patient Perception and Diagnostic Data|
- long term satisfaction of patients post INTRACOR treatment based on a questionnaire [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Satisfaction is assesed by three questions:
Do you fell comfortable with the treatment result? Would you do the traetment again? Would you recommend the treatment to a relativ or a friend?
If two out of these three questions are answered with "yes" then it can be assumed that the patient is satisfied.
- Determination if there is any correlation between patient satisfaction and subjective/objective diagnostic data. [ Time Frame: 36 months ] [ Designated as safety issue: No ]Objective: Change in topographic map Subjective: uncorrected near visual acuity, uncorrected distance visual acuity
|Study Start Date:||July 2010|
|Study Completion Date:||October 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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"
study arm II
patients who have been enrolled in the previous study "Intrastromal Presbyopia Correction by Means of Femtosecond Laser (study # 0905)"
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)".
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164358
|University of Heidelberg, department Ophthamology|
|Heidelberg, Baden-Württemberg, Germany, 69120|
|FreeVis LASIK Center Mannheim GmbH|
|Mannheim, Baden-Württemberg, Germany, 68167|
|Augenklinik am Marienplatz AG & Co. KG|
|Munic, Bavaria, Germany, 80331|
|ye-clinic for Refractive and Ophthalmo-Surgery, EJK Niederrhein|
|Duisburg, North Rhine-Westphalia, Germany, 47169|
|Principal Investigator:||Mike P. Holzer, Prof. Dr. med||University of Heidelberg, department Ophthalmology|