Intrastromal Presbyopia Correction by Means of a Femtosecond Laser

June 8, 2011 updated by: Technolas Perfect Vision GmbH
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • University Eye Clinic Heidelberg
      • Mannheim, Baden-Württemberg, Germany, 68167
        • FreeVis LASIK Center Mannheim GmbH
    • Bavaria
      • Munich, Bavaria, Germany, 80331
        • Augenklinik am Marienplatz AG & Co. KG
    • North Rhine-Westphalia
      • Duisburg, North Rhine-Westphalia, Germany, 47169
        • Eye-clinic for Refractive and Ophthalmo-Surgery, EJK Niederrhein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
In this group the smallest ring diameter will be applied.
Procedure: Intrastromal Correction of Presbyopia
On all patients an intrastromal pattern consisting of concentric rings will be applied.
Experimental: Group B
In this group the intermediate ring diameter will be applied.
Procedure: Intrastromal Correction of Presbyopia
On all patients an intrastromal pattern consisting of concentric rings will be applied.
Experimental: Group C
In this group the biggest ring diameter will be applied.
Procedure: Intrastromal Correction of Presbyopia
On all patients an intrastromal pattern consisting of concentric rings will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technolas Perfect Vision GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 25, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (Estimate)

December 3, 2009

Study Record Updates

Last Update Posted (Estimate)

June 9, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0905

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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