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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

November 25, 2009
June 8, 2011
December 2009
May 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01025050 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Intrastromal Presbyopia Correction by Means of a Femtosecond Laser
Intrastromal Presbyopia Correction by Means of a Femtosecond Laser

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Presbyopia
Procedure: Intrastromal Correction of Presbyopia
On all patients an intrastromal pattern consisting of concentric rings will be applied.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
December 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01025050
0905
Yes
Priv.-Doz. Dr. med. Mike P. Holzer, University Ophthalmic Clinic, Heidelberg
Technolas Perfect Vision GmbH
Not Provided
Not Provided
Technolas Perfect Vision GmbH
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP