Status:
UNKNOWN
Intrastromal Correction of Ametropia by a Femtosecond Laser
Lead Sponsor:
20/10 Perfect Vision
Conditions:
Presbyopia
Myopia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study evaluates the intrastromal correction of ametropia with a femtosecond laser made by 20/10 PERFECT VISION. This laser generates a beam of ultrashort, infrared pulses which enables very preci...
Eligibility Criteria
Inclusion
- age: \> 18 years
- stable distance refraction for at least one year (i.e. a maximum change of 0.5 D)
- in the case of presbyopia: minimum near add +2D to + 4D
- in the case of myopia or hyperopia (without astigmatism): minimal 1D and maximum 3D
- in the case of myopia or hyperopia (with astigmatism): spherical equivalent of minimal 1D and maximum 3D
- BSCVA of the eye to be treated \>= 0.63
- patients are willing and in such conditions to come to the follow-up exams
- no further ocular pathologies
Exclusion
- age: \< 18 years
- refraction less than +/- 1 D or higher than +/- 3 D (not valid for presbyopia patients)
- minimal pachymetry of \< 500µm
- K-mean \< 37 D or \> 60 D
- Difference (K-max minus K-min) \> 5D
- Difference cycloplegic refraction to subjective refraction more than 1 D (valid only for hyperopia correction)
- patients with previous intraocular or corneal surgeries (e.g. post-LASIK or PRK patients). Exemption: standard cataract surgery.
- patients with one or more of the following ocular pathologies:
- keratokonus
- corneal scars
- transplanted cornea
- disorders of wound healing
- trauma
- glaucoma
- epilepsia
- nystagmus
- lack of concentration
- other complicated illnesses
- diabetes mellitus
- instable K-readings as a sign of instable cornea
- weakness of connective tissue
- sensitivity against the drugs used in the study
- continuous wearing of contact lenses before the pre-exam, and before the surgery. At least 14 days before these dates patients must abstain from wearing CL.
- patients in pregnancy or during lactation
- patients who take part in another clinical trial
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00928122
Start Date
July 1 2008
End Date
December 1 2012
Last Update
February 9 2010
Active Locations (3)
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1
Klinik für Refraktive und Ophthalmo-Chirurgie des EJK Niederrhein
Duisburg, Germany, 47169
2
FreeVis LASIK Zentrum Mannheim GmbH
Mannheim, Germany, 68167
3
Augenklinik am Marienplatz AG & Co. KG
München, Germany, 80331