Intrastromal Correction of Ametropia by a Femtosecond Laser

NCT ID: NCT00928122

Last Updated: 2010-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2012-12-31

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.

Conditions

Presbyopia; Myopia; Hyperopia; Astigmatism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 / Presbyopia

Presbyopic patients, slightly hyperopes

Group Type: EXPERIMENTAL

Intrastromal Correction of Presbyopia

Intervention Type: DEVICE

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.

2 / Myopia

Myopic patients without Astigmatism

Group Type: EXPERIMENTAL

Intrastromal correction of Myopia

Intervention Type: DEVICE

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.

3 / Hyperopia

Hyperope patients without Astigmatism

Group Type: EXPERIMENTAL

Intrastromal Correction of Hyperopia

Intervention Type: DEVICE

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.

4 / Myopia with Astigmatism

Myopic patients incl. Astigmatism

Group Type: EXPERIMENTAL

Intrastromal Correction of Myopia incl. Astigmatism

Intervention Type: DEVICE

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.

5 / Hyperopia with Astigmatism

Hyperope patients incl. Astigmatism

Group Type: EXPERIMENTAL

Intrastromal Correction of Hyperopia incl. Astigmatism

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

- FEMTEC Laser System; - Patient Interface; FEMTEC Laser System; FEMTEC Laser System; FEMTEC Laser System; FEMTEC Laser System

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

20/10 Perfect Vision

INDUSTRY

Sponsor Role: lead

Responsible Party

Universitaets-Augenklinik Heidelberg

Principal Investigators

Gerd U. Auffarth, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitäts-Augenklinik Heidelberg

Locations

Klinik für Refraktive und Ophthalmo-Chirurgie des EJK Niederrhein

Duisburg, , Germany

Site Status: RECRUITING

FreeVis LASIK Zentrum Mannheim GmbH

Mannheim, , Germany

Site Status: RECRUITING

Augenklinik am Marienplatz AG & Co. KG

München, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Mike P. Holzer, PD Dr. med.

Role: CONTACT

mike.holzer@med.uni-heidelberg.de

+49 6221 56 ext. 6999

Gerd U. Auffarth, Prof. Dr.

Role: CONTACT

ga@uni-hd.de

+49 6221 56 ext. 36631

Facility Contacts

Mark Tomalla, Dr. med.

Role: primary

Mark.Tomalla@EJK.de

+49 203 508 ext. 1711

Michael C. Knorz, Prof. Dr.

Role: primary

mannheim@freevis.de

+49 621 383 ext. 3410

Tobias Neuhann, Dr. med.

Role: primary

ceo@a-a-m.de

+49 89 232410 ext. 0

References

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.

Reference Type: DERIVED

PMID: 25185255 (View on PubMed)

Other Identifiers

ISCAF

Identifier Type: -

Identifier Source: org_study_id