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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 / Presbyopia | Experimental | Presbyopic patients, slightly hyperopes |
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| 2 / Myopia | Experimental | Myopic patients without Astigmatism |
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| 3 / Hyperopia | Experimental | Hyperope patients without Astigmatism |
|
| 4 / Myopia with Astigmatism | Experimental | Myopic patients incl. Astigmatism |
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| 5 / Hyperopia with Astigmatism | Experimental | Hyperope patients incl. Astigmatism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrastromal Correction of Presbyopia | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prove safety and effectiveness as well as improvement in near visual acuity performance and increase in near visual acuity. | 3 months |
| Measure | Description | 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 |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mike P. Holzer, PD Dr. med. | Contact | +49 6221 56 | 6999 | mike.holzer@med.uni-heidelberg.de |
| Gerd U. Auffarth, Prof. Dr. | Contact | +49 6221 56 | 36631 | ga@uni-hd.de |
| Name | Affiliation | Role |
|---|---|---|
| Gerd U. Auffarth, Prof. Dr. | Universitäts-Augenklinik Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Refraktive und Ophthalmo-Chirurgie des EJK Niederrhein | Recruiting | Duisburg | 47169 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25185255 | Derived | Khoramnia R, Fitting A, Rabsilber TM, Thomas BC, Auffarth GU, Holzer MP. Intrastromal femtosecond laser surgical compensation of presbyopia with six intrastromal ring cuts: 3-year results. Br J Ophthalmol. 2015 Feb;99(2):170-6. doi: 10.1136/bjophthalmol-2014-305642. Epub 2014 Sep 2. |
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|
| Intrastromal correction of Myopia | Device | 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. |
|
|
| Intrastromal Correction of Hyperopia | Device | 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. |
|
|
| Intrastromal Correction of Myopia incl. Astigmatism | Device | 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. |
|
|
| Intrastromal Correction of Hyperopia incl. Astigmatism | Device | 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. |
|
|
| FreeVis LASIK Zentrum Mannheim GmbH | Recruiting | Mannheim | 68167 | Germany |
|
| Augenklinik am Marienplatz AG & Co. KG | Recruiting | München | 80331 | Germany |
|
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D009216 | Myopia |
| D006956 | Hyperopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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