Intrastromal Presbyopia Correction by Means of a Femtosecond Laser

This study has been completed.

Sponsor:

Information provided by:

Technolas Perfect Vision GmbH

ClinicalTrials.gov Identifier:

NCT01025050

First received: November 25, 2009

Last updated: June 8, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	November 25, 2009
Last Updated Date	June 8, 2011
Start Date ^ICMJE	December 2009
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 2, 2009)	The proportion of treated eyes who gained uncorrected near visual acuity of at least 2 lines. This proportion should be greater than 70%. [ Time Frame: 6 months follow up ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01025050 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 2, 2009)	The proportion of treated eyes that lose more than two lines of best corrected visual acuity (BSCVA). This proportion should be no greater than 5 %. [ Time Frame: 6 months follow up ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Intrastromal Presbyopia Correction by Means of a Femtosecond Laser
Official Title ^ICMJE	Intrastromal Presbyopia Correction by Means of a Femtosecond Laser
Brief Summary	This clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. 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.
Detailed Description	This clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. The incisions are applied by means of the FEMTEC femtosecond laser system with the INTRACOR software module using patterns consisting of 6 concentric rings and 3 different inner ring diameters. A similar pattern with 5 concentric rings and only one fixed inner diameter is currently under clinical investigation. 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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Presbyopia
Intervention ^ICMJE	Procedure: Intrastromal Correction of Presbyopia On all patients an intrastromal pattern consisting of concentric rings will be applied.
Study Arm (s)	Experimental: Group A In this group the smallest ring diameter will be applied. Intervention: Procedure: Intrastromal Correction of Presbyopia Experimental: Group B In this group the intermediate ring diameter will be applied. Intervention: Procedure: Intrastromal Correction of Presbyopia Experimental: Group C In this group the biggest ring diameter will be applied. Intervention: Procedure: Intrastromal Correction of Presbyopia
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	58
Completion Date	December 2010
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age: at least 18 years old 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: Minimum cornea thickness < 500 µm 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01025050
Other Study ID Numbers ^ICMJE	0905
Has Data Monitoring Committee	Yes
Responsible Party	Priv.-Doz. Dr. med. Mike P. Holzer, University Ophthalmic Clinic, Heidelberg
Study Sponsor ^ICMJE	Technolas Perfect Vision GmbH
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Technolas Perfect Vision GmbH
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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