Intrastromal Correction of Ametropia by a Femtosecond Laser (ISCAF)

20/10 Perfect Vision

Status and phase: Unknown; Phase 3

Conditions: Myopia; Astigmatism; Presbyopia; Hyperopia

Treatments: Device: Intrastromal Correction of Hyperopia; Device: Intrastromal Correction of Hyperopia incl. Astigmatism; Device: Intrastromal correction of Myopia; Device: Intrastromal Correction of Myopia incl. Astigmatism; Device: Intrastromal Correction of Presbyopia

Study type: Interventional

Funder types: Industry

Identifiers

NCT00928122

ISCAF

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 5 patient groups

1 / Presbyopia

Experimental group

Description:

Presbyopic patients, slightly hyperopes

Treatment:

Device: Intrastromal Correction of Presbyopia

2 / Myopia

Experimental group

Description:

Myopic patients without Astigmatism

Treatment:

Device: Intrastromal correction of Myopia

3 / Hyperopia

Experimental group

Description:

Hyperope patients without Astigmatism

Treatment:

Device: Intrastromal Correction of Hyperopia

4 / Myopia with Astigmatism

Experimental group

Description:

Myopic patients incl. Astigmatism

Treatment:

Device: Intrastromal Correction of Myopia incl. Astigmatism

5 / Hyperopia with Astigmatism

Experimental group

Description:

Hyperope patients incl. Astigmatism

Treatment:

Device: Intrastromal Correction of Hyperopia incl. Astigmatism