Status:
COMPLETED
Long Term Observation of Patient Satisfaction Post INTRACOR Treatment Based on Patient Perception and Diagnostic Data
Lead Sponsor:
Technolas Perfect Vision GmbH
Conditions:
Presbyopia
Eligibility:
All Genders
18+ years
Brief Summary
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 sati...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Age: at least 18 years old
- 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
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01164358
Start Date
July 1 2010
End Date
October 1 2013
Last Update
October 21 2013
Active Locations (4)
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1
University of Heidelberg, department Ophthamology
Heidelberg, Baden-Wurttemberg, Germany, 69120
2
FreeVis LASIK Center Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany, 68167
3
Augenklinik am Marienplatz AG & Co. KG
Munich, Bavaria, Germany, 80331
4
ye-clinic for Refractive and Ophthalmo-Surgery, EJK Niederrhein
Duisburg, North Rhine-Westphalia, Germany, 47169