Intrastromal Correction of Ametropia by a Femtosecond Laser
ISCAF
1 other identifier
interventional
200
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2008
Typical duration for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 3, 2009
CompletedFirst Posted
Study publicly available on registry
June 25, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFebruary 9, 2010
February 1, 2010
6 months
June 3, 2009
February 7, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Prove safety and effectiveness as well as improvement in near visual acuity performance and increase in near visual acuity.
3 months
Secondary Outcomes (2)
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
Study Arms (5)
1 / Presbyopia
EXPERIMENTALPresbyopic patients, slightly hyperopes
2 / Myopia
EXPERIMENTALMyopic patients without Astigmatism
3 / Hyperopia
EXPERIMENTALHyperope patients without Astigmatism
4 / Myopia with Astigmatism
EXPERIMENTALMyopic patients incl. Astigmatism
5 / Hyperopia with Astigmatism
EXPERIMENTALHyperope patients incl. Astigmatism
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Klinik für Refraktive und Ophthalmo-Chirurgie des EJK Niederrhein
Duisburg, 47169, Germany
FreeVis LASIK Zentrum Mannheim GmbH
Mannheim, 68167, Germany
Augenklinik am Marienplatz AG & Co. KG
München, 80331, Germany
Related Publications (1)
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.
PMID: 25185255DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerd U. Auffarth, Prof. Dr.
Universitäts-Augenklinik Heidelberg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 3, 2009
First Posted
June 25, 2009
Study Start
July 1, 2008
Primary Completion
January 1, 2009
Study Completion
December 1, 2012
Last Updated
February 9, 2010
Record last verified: 2010-02