Intrastromal Presbyopia Correction by Means of a Femtosecond Laser

Presbyopia Clinical Trial

Official title:

Intrastromal Presbyopia Correction by Means of a Femtosecond Laser

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025050
• Other study ID #: 0905
• Status: Completed
• Phase: Phase 3
• First received: November 25, 2009
• Last updated: June 8, 2011
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: Technolas Perfect Vision GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Bavarian Health and Food Safety Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Presbyopia

Intervention

Procedure:
• Intrastromal Correction of Presbyopia
On all patients an intrastromal pattern consisting of concentric rings will be applied.

Locations

Country	Name	City	State
Germany	Eye-clinic for Refractive and Ophthalmo-Surgery, EJK Niederrhein	Duisburg	North Rhine-Westphalia
Germany	University Eye Clinic Heidelberg	Heidelberg	Baden-Württemberg
Germany	FreeVis LASIK Center Mannheim GmbH	Mannheim	Baden-Württemberg
Germany	Augenklinik am Marienplatz AG & Co. KG	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technolas Perfect Vision GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of treated eyes who gained uncorrected near visual acuity of at least 2 lines. This proportion should be greater than 70%.		6 months follow up	No
Secondary	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 %.		6 months follow up	Yes