Intrastromal Correction of Ametropia by a Femtosecond Laser - Full Text View

Purpose

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.

Condition	Intervention	Phase
Presbyopia Myopia Hyperopia Astigmatism	Device: Intrastromal Correction of Presbyopia Device: Intrastromal correction of Myopia Device: Intrastromal Correction of Hyperopia Device: Intrastromal Correction of Myopia incl. Astigmatism Device: Intrastromal Correction of Hyperopia incl. Astigmatism	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Intrastromal Correction of Ametropia by a Femtosecond Laser

Resource links provided by NLM:

MedlinePlus related topics: Corneal Disorders

U.S. FDA Resources

Further study details as provided by 20/10 Perfect Vision:

Primary Outcome Measures:

Prove safety and effectiveness as well as improvement in near visual acuity performance and increase in near visual acuity. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Validate the 3 months results [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2012
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 / Presbyopia Presbyopic patients, slightly hyperopes	Device: Intrastromal Correction of Presbyopia 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. Other Names: - FEMTEC Laser System - Patient Interface
Experimental: 2 / Myopia Myopic patients without Astigmatism	Device: Intrastromal correction of Myopia 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. Other Name: FEMTEC Laser System
Experimental: 3 / Hyperopia Hyperope patients without Astigmatism	Device: Intrastromal Correction of Hyperopia 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. Other Name: FEMTEC Laser System
Experimental: 4 / Myopia with Astigmatism Myopic patients incl. Astigmatism	Device: Intrastromal Correction of Myopia incl. Astigmatism 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. Other Name: FEMTEC Laser System
Experimental: 5 / Hyperopia with Astigmatism Hyperope patients incl. Astigmatism	Device: Intrastromal Correction of Hyperopia incl. Astigmatism 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. Other Name: FEMTEC Laser System

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928122

Contacts

Contact: Mike P. Holzer, PD Dr. med.	+49 6221 56 ext 6999	mike.holzer@med.uni-heidelberg.de
Contact: Gerd U. Auffarth, Prof. Dr.	+49 6221 56 ext 36631	ga@uni-hd.de

Locations

Germany
Klinik für Refraktive und Ophthalmo-Chirurgie des EJK Niederrhein	Recruiting
Duisburg, Germany, 47169
Contact: Mark Tomalla, Dr. med. +49 203 508 ext 1711 Mark.Tomalla@EJK.de
Principal Investigator: Mark Tomalla, Dr. med.
FreeVis LASIK Zentrum Mannheim GmbH	Recruiting
Mannheim, Germany, 68167
Contact: Michael C. Knorz, Prof. Dr. +49 621 383 ext 3410 mannheim@freevis.de
Principal Investigator: Michael C. Knorz, Prof. Dr.
Augenklinik am Marienplatz AG & Co. KG	Recruiting
Muenchen, Germany, 80331
Contact: Tobias Neuhann, Dr. med. +49 89 232410 ext 0 ceo@a-a-m.de
Principal Investigator: Tobias Neuhann, Dr. med.

Sponsors and Collaborators

20/10 Perfect Vision

Investigators

Principal Investigator:

Gerd U. Auffarth, Prof. Dr.

Universitäts-Augenklinik Heidelberg

More Information

No publications provided

Responsible Party:	Priv.-Doz. Dr. med. Mike P. Holzer, Universitaets-Augenklinik Heidelberg
ClinicalTrials.gov Identifier:	NCT00928122 History of Changes
Other Study ID Numbers:	ISCAF
Study First Received:	June 3, 2009
Last Updated:	February 7, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Astigmatism
Hyperopia
Myopia

Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013

Intrastromal Correction of Ametropia by a Femtosecond Laser (ISCAF)