Astigmatism, Hyperopia, Myopia, Presbyopia
Conditions
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 precise cuts in the cornea. By these cuts lamellae of the cornea are separated locally, and in the consequence the curvature of the cornea is changed, and the correction of the diagnosed ametropia can be achieved. On the contrary to cuts which are generated with a sharp knife, the cuts generated when using a laser can be generated just inside the cornea without opening the surface of the cornea. This means the procedure is minimal-invasive. The study hypothesis is: Different types of ametropia can be corrected safely and on long-term by intrastromal cuts.
Interventions
Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
DEVICEIntrastromal correction of Myopia
Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
DEVICEIntrastromal Correction of Hyperopia
Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
DEVICEIntrastromal Correction of Myopia incl. Astigmatism
Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
DEVICEIntrastromal Correction of Hyperopia incl. Astigmatism
Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
Sponsors
20/10 Perfect Vision
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prove safety and effectiveness as well as improvement in near visual acuity performance and increase in near visual acuity. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Validate the 3 months results | 6 months |
| Prove stability of distance visual acuity and safety of the procedure regarding infections and inflammatory response as well as corneal endothelial cell counts. | 6 months |
Countries
Germany
Contacts
Primary ContactMike P. Holzer, PD Dr. med.
Backup ContactGerd U. Auffarth, Prof. Dr.
Outcome results
None listed