Impact of Personality on Satisfaction Following Presbyopic Correction
NCT05191329
Behavior, Eye Diseases
Alexandroupoli, Evros, Greece
View Trial DetailsNCT Number: NCT01164358
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.
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All sexes
Observational
University of Heidelberg, department Ophthamology, Heidelberg, Baden-Wurttemberg, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 36 months
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.
Time frame: 36 months
Objective: Change in topographic map Subjective: uncorrected near visual acuity, uncorrected distance visual acuity
Technolas Perfect Vision GmbH
Industry
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