Intrastromal Correction of Ametropia by a Femtosecond Laser

Phase 3

• Conditions: Myopia; Presbyopia; Hyperopia; Astigmatism
• Interventions: Device: Intrastromal Correction of Hyperopia; Device: Intrastromal Correction of Myopia incl. Astigmatism; Device: Intrastromal Correction of Hyperopia incl. Astigmatism; Device: Intrastromal Correction of Presbyopia; Device: Intrastromal correction of Myopia

• Registration Number: NCT00928122
• Lead Sponsor: 20/10 Perfect Vision

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2009-01
• Study First Submitted: 2009-06-03
• Study First Submitted QC: 2009-06-24
• Study First Posted: 2009-06-25
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-07
• Last Update Posted: 2010-02-09
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3 / Hyperopia	Intrastromal Correction of Hyperopia	Hyperope patients without Astigmatism
4 / Myopia with Astigmatism	Intrastromal Correction of Myopia incl. Astigmatism	Myopic patients incl. Astigmatism
5 / Hyperopia with Astigmatism	Intrastromal Correction of Hyperopia incl. Astigmatism	Hyperope patients incl. Astigmatism
1 / Presbyopia	Intrastromal Correction of Presbyopia	Presbyopic patients, slightly hyperopes
2 / Myopia	Intrastromal correction of Myopia	Myopic patients without Astigmatism

Primary Outcome Measures

Name	Time	Method
Prove safety and effectiveness as well as improvement in near visual acuity performance and increase in near visual acuity.	3 months

Secondary Outcome Measures

Name	Time	Method
Validate the 3 months results	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.	6 months

Trial Locations

Locations (3)

Klinik für Refraktive und Ophthalmo-Chirurgie des EJK Niederrhein; 🇩🇪 Duisburg, Germany

FreeVis LASIK Zentrum Mannheim GmbH; 🇩🇪 Mannheim, Germany

Augenklinik am Marienplatz AG & Co. KG; 🇩🇪 Muenchen, Germany