Intrastromal Presbyopia Correction by Means of a Femtosecond Laser
NCT ID: NCT01025050
Last Updated: 2011-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
58 participants
INTERVENTIONAL
2009-12-31
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
In this group the smallest ring diameter will be applied.
Intrastromal Correction of Presbyopia
On all patients an intrastromal pattern consisting of concentric rings will be applied.
Group B
In this group the intermediate ring diameter will be applied.
Intrastromal Correction of Presbyopia
On all patients an intrastromal pattern consisting of concentric rings will be applied.
Group C
In this group the biggest ring diameter will be applied.
Intrastromal Correction of Presbyopia
On all patients an intrastromal pattern consisting of concentric rings will be applied.
Interventions
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Intrastromal Correction of Presbyopia
On all patients an intrastromal pattern consisting of concentric rings will be applied.
Eligibility Criteria
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Inclusion Criteria
* Patients must have read, understood and signed the Patient Information
* Patients are willing and able to return for follow-up examinations
* Stable distance refraction
* Manifested Refraction (see Table 1 for more details) :
* Cylinder: -0.5 D to 0 D
* Sphere: 0.25 D to 1.25 D
* Spherical equivalent: Minimum 0.25 D
* Best corrected distance visual acuity of the eye to be treated at least 0.8
* Subjects must have presbyopia as determined by an age-related need for optical aid (≥ +1.5 D) for reading with their best distance correction.
Exclusion Criteria
* Ocular dominance (only non-dominant eyes should be included)
* Uncorrected Near Visual Acuity of 0.5 or better
* Difference between manifested and cycloplegic refraction of \> 0.75 D in spherical equivalent
* Median K values \< 40 D or \> 46 D
* Topographical astigmatism \> 5 D
* Abnormal corneal topography
* Patients with previous corneal operations on the eye to be treated (e.g. LASIK, PRK, X-Linking; this does not include cataract operations)
* Scarring or opacity of the cornea
* Transplanted cornea
* Connective tissue weaknesses
* Keratectasia and other diseases of the cornea
* Patients with wound-healing disorders such as connective tissue disease, autoimmune illnesses, immunodeficiency illnesses, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis
* Patients regularly taking medicines that could influence the result of the treatment
* Glaucoma or a risk of glaucoma
* Patients with concentration disorders, epilepsy, diabetes mellitus and other complicating diseases
* Patients with disorders of the ocular muscle, such as nystagmus or strabismus
* Sensitivities to the drugs used in this study
* Continual wearing of contact lenses before the pre-examination and before the operation. Patients must refrain from wearing contact lenses for at least 14 days prior to these dates
* Patients who are pregnant or are lactating
* Patients who are participating in another ophthalmological clinical study
* Best corrected distance visual acuity of the second, not to be treated eye is 0.5 or less.
18 Years
ALL
No
Sponsors
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Technolas Perfect Vision GmbH
INDUSTRY
Responsible Party
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University Ophthalmic Clinic, Heidelberg
Locations
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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
Countries
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References
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Thomas BC, Fitting A, Khoramnia R, Rabsilber TM, Auffarth GU, Holzer MP. Long-term outcomes of intrastromal femtosecond laser presbyopia correction: 3-year results. Br J Ophthalmol. 2016 Nov;100(11):1536-1541. doi: 10.1136/bjophthalmol-2015-307672. Epub 2016 Feb 22.
Other Identifiers
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0905
Identifier Type: -
Identifier Source: org_study_id
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