Intrastromal Correction of Ametropia by a Femtosecond Laser (ISCAF)

February 7, 2010 updated by: 20/10 Perfect Vision

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

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
      • Duisburg, Germany, 47169
        • Recruiting
        • Klinik für Refraktive und Ophthalmo-Chirurgie des EJK Niederrhein
        • Contact:
        • Principal Investigator:
          • Mark Tomalla, Dr. med.
      • Mannheim, Germany, 68167
        • Recruiting
        • FreeVis LASIK Zentrum Mannheim GmbH
        • Contact:
        • Principal Investigator:
          • Michael C. Knorz, Prof. Dr.
      • Muenchen, Germany, 80331
        • Recruiting
        • Augenklinik am Marienplatz AG & Co. KG
        • Contact:
          • Tobias Neuhann, Dr. med.
          • Phone Number: +49 89 232410
          • Email: ceo@a-a-m.de
        • Principal Investigator:
          • Tobias Neuhann, Dr. med.

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: > 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

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • FEMTEC Laser System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prove safety and effectiveness as well as improvement in near visual acuity performance and increase in near visual acuity.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Validate the 3 months results
Time Frame: 6 months
6 months
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
6 months

Collaborators and Investigators

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

Sponsor

20/10 Perfect Vision

Investigators

  • Principal Investigator: Gerd U. Auffarth, Prof. Dr., Universitäts-Augenklinik Heidelberg

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

July 1, 2008

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

June 3, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (ESTIMATE)

June 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2010

Last Update Submitted That Met QC Criteria

February 7, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISCAF

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.

Clinical Trials on Presbyopia

Clinical Trials on Intrastromal Correction of Presbyopia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe