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Intrastromal Presbyopia Correction by Means of a Femtosecond Laser

Primary Purpose

Presbyopia

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Intrastromal Correction of Presbyopia
Sponsored by
Technolas Perfect Vision GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Presbyopia, Intrastromal, Femtosecond Laser, minimal-invasive, INTRACOR, Enhance Near Visual Acuity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Eye Clinic Heidelberg
  • FreeVis LASIK Center Mannheim GmbH
  • Augenklinik am Marienplatz AG & Co. KG
  • Eye-clinic for Refractive and Ophthalmo-Surgery, EJK Niederrhein

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

In this group the smallest ring diameter will be applied.

In this group the intermediate ring diameter will be applied.

In this group the biggest ring diameter will be applied.

Outcomes

Primary Outcome Measures

The proportion of treated eyes who gained uncorrected near visual acuity of at least 2 lines. This proportion should be greater than 70%.

Secondary Outcome Measures

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 %.

Full Information

First Posted
November 25, 2009
Last Updated
June 8, 2011
Sponsor
Technolas Perfect Vision GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01025050
Brief Title
Intrastromal Presbyopia Correction by Means of a Femtosecond Laser
Official Title
Intrastromal Presbyopia Correction by Means of a Femtosecond Laser
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Technolas Perfect Vision GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Presbyopia, Intrastromal, Femtosecond Laser, minimal-invasive, INTRACOR, Enhance Near Visual Acuity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
In this group the smallest ring diameter will be applied.
Arm Title
Group B
Arm Type
Experimental
Arm Description
In this group the intermediate ring diameter will be applied.
Arm Title
Group C
Arm Type
Experimental
Arm Description
In this group the biggest ring diameter will be applied.
Intervention Type
Procedure
Intervention Name(s)
Intrastromal Correction of Presbyopia
Intervention Description
On all patients an intrastromal pattern consisting of concentric rings will be applied.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University Eye Clinic Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
FreeVis LASIK Center Mannheim GmbH
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Augenklinik am Marienplatz AG & Co. KG
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80331
Country
Germany
Facility Name
Eye-clinic for Refractive and Ophthalmo-Surgery, EJK Niederrhein
City
Duisburg
State/Province
North Rhine-Westphalia
ZIP/Postal Code
47169
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26903524
Citation
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.
Results Reference
derived

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Intrastromal Presbyopia Correction by Means of a Femtosecond Laser

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