This clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. The hypothesis of the study is that by means of intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and effective way.
This clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. The incisions are applied by means of the FEMTEC femtosecond laser system with the INTRACOR software module using patterns consisting of 6 concentric rings and 3 different inner ring diameters. A similar pattern with 5 concentric rings and only one fixed inner diameter is currently under clinical investigation. The hypothesis of the study is that by means of intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and effective way. The intrastromal incisions are performed by the femtosecond laser FEMTEC, which is CE certified for various therapeutic indications. The incision eliminates both an epithelial and an endothelial opening of the cornea whereby the minimally invasive character of this form of treatment is guaranteed. A detailed pre-operative examination will ensure that every interested and willing patient fulfils the inclusion criteria of this study. Post-operative examinations, which should document the success of the treatment, are to be carried out after 24 hours, 1 week, 1 month, 3 months and 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
On all patients an intrastromal pattern consisting of concentric rings will be applied.
University Eye Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
FreeVis LASIK Center Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany
Augenklinik am Marienplatz AG & Co. KG
Munich, Bavaria, Germany
Eye-clinic for Refractive and Ophthalmo-Surgery, EJK Niederrhein
Duisburg, North Rhine-Westphalia, Germany
The proportion of treated eyes who gained uncorrected near visual acuity of at least 2 lines. This proportion should be greater than 70%.
Time frame: 6 months follow up
The proportion of treated eyes that lose more than two lines of best corrected visual acuity (BSCVA). This proportion should be no greater than 5 %.
Time frame: 6 months follow up
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