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Intrastromal Correction of Ametropia by a Femtosecond Laser (ISCAF)

Primary Purpose

Presbyopia, Myopia, Hyperopia

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Intrastromal Correction of Presbyopia
Intrastromal correction of Myopia
Intrastromal Correction of Hyperopia
Intrastromal Correction of Myopia incl. Astigmatism
Intrastromal Correction of Hyperopia incl. Astigmatism
Sponsored by
20/10 Perfect Vision
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

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

Inclusion Criteria:

  • age: > 18 years
  • stable distance refraction for at least one year (i.e. a maximum change of 0.5 D)
  • in the case of presbyopia: minimum near add +2D to + 4D
  • in the case of myopia or hyperopia (without astigmatism): minimal 1D and maximum 3D
  • in the case of myopia or hyperopia (with astigmatism): spherical equivalent of minimal 1D and maximum 3D
  • BSCVA of the eye to be treated >= 0.63
  • patients are willing and in such conditions to come to the follow-up exams
  • no further ocular pathologies

Exclusion Criteria:

  • age: < 18 years
  • refraction less than +/- 1 D or higher than +/- 3 D (not valid for presbyopia patients)
  • minimal pachymetry of < 500µm
  • K-mean < 37 D or > 60 D
  • Difference (K-max minus K-min) > 5D
  • Difference cycloplegic refraction to subjective refraction more than 1 D (valid only for hyperopia correction)
  • patients with previous intraocular or corneal surgeries (e.g. post-LASIK or PRK patients). Exemption: standard cataract surgery.

  • patients with one or more of the following ocular pathologies:

    • keratokonus
    • corneal scars
    • transplanted cornea
    • disorders of wound healing
    • trauma
    • glaucoma
    • epilepsia
    • nystagmus
    • lack of concentration
    • other complicated illnesses
    • diabetes mellitus
    • instable K-readings as a sign of instable cornea
    • weakness of connective tissue
    • sensitivity against the drugs used in the study
    • continuous wearing of contact lenses before the pre-exam, and before the surgery. At least 14 days before these dates patients must abstain from wearing CL.
    • patients in pregnancy or during lactation
    • patients who take part in another clinical trial

Sites / Locations

  • Klinik für Refraktive und Ophthalmo-Chirurgie des EJK NiederrheinRecruiting
  • FreeVis LASIK Zentrum Mannheim GmbHRecruiting
  • Augenklinik am Marienplatz AG & Co. KGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1 / Presbyopia

2 / Myopia

3 / Hyperopia

4 / Myopia with Astigmatism

5 / Hyperopia with Astigmatism

Arm Description

Presbyopic patients, slightly hyperopes

Myopic patients without Astigmatism

Hyperope patients without Astigmatism

Myopic patients incl. Astigmatism

Hyperope patients incl. Astigmatism

Outcomes

Primary Outcome Measures

Prove safety and effectiveness as well as improvement in near visual acuity performance and increase in near visual acuity.

Secondary Outcome Measures

Validate the 3 months results
Prove stability of distance visual acuity and safety of the procedure regarding infections and inflammatory response as well as corneal endothelial cell counts.

Full Information

First Posted
June 3, 2009
Last Updated
February 7, 2010
Sponsor
20/10 Perfect Vision
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1. Study Identification

Unique Protocol Identification Number
NCT00928122
Brief Title
Intrastromal Correction of Ametropia by a Femtosecond Laser
Acronym
ISCAF
Official Title
Intrastromal Correction of Ametropia by a Femtosecond Laser
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
20/10 Perfect Vision

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the intrastromal correction of ametropia with a femtosecond laser made by 20/10 PERFECT VISION. This laser generates a beam of ultrashort, infrared pulses which enables very precise cuts in the cornea. By these cuts lamellae of the cornea are separated locally, and in the consequence the curvature of the cornea is changed, and the correction of the diagnosed ametropia can be achieved. On the contrary to cuts which are generated with a sharp knife, the cuts generated when using a laser can be generated just inside the cornea without opening the surface of the cornea. This means the procedure is minimal-invasive. The study hypothesis is: Different types of ametropia can be corrected safely and on long-term by intrastromal cuts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia, Myopia, Hyperopia, Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 / Presbyopia
Arm Type
Experimental
Arm Description
Presbyopic patients, slightly hyperopes
Arm Title
2 / Myopia
Arm Type
Experimental
Arm Description
Myopic patients without Astigmatism
Arm Title
3 / Hyperopia
Arm Type
Experimental
Arm Description
Hyperope patients without Astigmatism
Arm Title
4 / Myopia with Astigmatism
Arm Type
Experimental
Arm Description
Myopic patients incl. Astigmatism
Arm Title
5 / Hyperopia with Astigmatism
Arm Type
Experimental
Arm Description
Hyperope patients incl. Astigmatism
Intervention Type
Device
Intervention Name(s)
Intrastromal Correction of Presbyopia
Other Intervention Name(s)
- FEMTEC Laser System, - Patient Interface
Intervention Description
Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
Intervention Type
Device
Intervention Name(s)
Intrastromal correction of Myopia
Other Intervention Name(s)
FEMTEC Laser System
Intervention Description
Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
Intervention Type
Device
Intervention Name(s)
Intrastromal Correction of Hyperopia
Other Intervention Name(s)
FEMTEC Laser System
Intervention Description
Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
Intervention Type
Device
Intervention Name(s)
Intrastromal Correction of Myopia incl. Astigmatism
Other Intervention Name(s)
FEMTEC Laser System
Intervention Description
Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
Intervention Type
Device
Intervention Name(s)
Intrastromal Correction of Hyperopia incl. Astigmatism
Other Intervention Name(s)
FEMTEC Laser System
Intervention Description
Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
Primary Outcome Measure Information:
Title
Prove safety and effectiveness as well as improvement in near visual acuity performance and increase in near visual acuity.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Validate the 3 months results
Time Frame
6 months
Title
Prove stability of distance visual acuity and safety of the procedure regarding infections and inflammatory response as well as corneal endothelial cell counts.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age: > 18 years stable distance refraction for at least one year (i.e. a maximum change of 0.5 D) in the case of presbyopia: minimum near add +2D to + 4D in the case of myopia or hyperopia (without astigmatism): minimal 1D and maximum 3D in the case of myopia or hyperopia (with astigmatism): spherical equivalent of minimal 1D and maximum 3D BSCVA of the eye to be treated >= 0.63 patients are willing and in such conditions to come to the follow-up exams no further ocular pathologies Exclusion Criteria: age: < 18 years refraction less than +/- 1 D or higher than +/- 3 D (not valid for presbyopia patients) minimal pachymetry of < 500µm K-mean < 37 D or > 60 D Difference (K-max minus K-min) > 5D Difference cycloplegic refraction to subjective refraction more than 1 D (valid only for hyperopia correction) patients with previous intraocular or corneal surgeries (e.g. post-LASIK or PRK patients). Exemption: standard cataract surgery. patients with one or more of the following ocular pathologies: keratokonus corneal scars transplanted cornea disorders of wound healing trauma glaucoma epilepsia nystagmus lack of concentration other complicated illnesses diabetes mellitus instable K-readings as a sign of instable cornea weakness of connective tissue sensitivity against the drugs used in the study continuous wearing of contact lenses before the pre-exam, and before the surgery. At least 14 days before these dates patients must abstain from wearing CL. patients in pregnancy or during lactation patients who take part in another clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mike P. Holzer, PD Dr. med.
Phone
+49 6221 56
Ext
6999
Email
mike.holzer@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Gerd U. Auffarth, Prof. Dr.
Phone
+49 6221 56
Ext
36631
Email
ga@uni-hd.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerd U. Auffarth, Prof. Dr.
Organizational Affiliation
Universitäts-Augenklinik Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Refraktive und Ophthalmo-Chirurgie des EJK Niederrhein
City
Duisburg
ZIP/Postal Code
47169
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Tomalla, Dr. med.
Phone
+49 203 508
Ext
1711
Email
Mark.Tomalla@EJK.de
First Name & Middle Initial & Last Name & Degree
Mark Tomalla, Dr. med.
Facility Name
FreeVis LASIK Zentrum Mannheim GmbH
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael C. Knorz, Prof. Dr.
Phone
+49 621 383
Ext
3410
Email
mannheim@freevis.de
First Name & Middle Initial & Last Name & Degree
Michael C. Knorz, Prof. Dr.
Facility Name
Augenklinik am Marienplatz AG & Co. KG
City
Muenchen
ZIP/Postal Code
80331
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Neuhann, Dr. med.
Phone
+49 89 232410
Ext
0
Email
ceo@a-a-m.de
First Name & Middle Initial & Last Name & Degree
Tobias Neuhann, Dr. med.

12. IPD Sharing Statement

Citations:
PubMed Identifier
25185255
Citation
Khoramnia R, Fitting A, Rabsilber TM, Thomas BC, Auffarth GU, Holzer MP. Intrastromal femtosecond laser surgical compensation of presbyopia with six intrastromal ring cuts: 3-year results. Br J Ophthalmol. 2015 Feb;99(2):170-6. doi: 10.1136/bjophthalmol-2014-305642. Epub 2014 Sep 2.
Results Reference
derived

Learn more about this trial

Intrastromal Correction of Ametropia by a Femtosecond Laser

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