Clinical Trial of the Femtosecond Laser System VisuMax for Refractive Correction of Hyperopia by Means of Lenticule Extraction

Tilganga Institute of Ophthalmology

Status: Unknown

Conditions: Hyperopia

Treatments: Procedure: Small incision lenticule extraction; Device: ReLEx® (SMILE)

Study type: Interventional

Funder types: Other

Identifiers

NCT02316041

177/2013

Details and patient eligibility

About

This is a feasibility and clinical evaluation study of the VisuMax femtosecond laser for refractive correction of hyperopia using the small incision lenticule extraction (ReLEx smile) method.

In ReLEx® the VisuMax femtosecond laser creates two interfaces that define a refractive lenticule of stromal tissue. In ReLEx® FLEx, the upper interface is converted into a LASIK flap by the creation of a sidecut. The LASIK flap is lifted and the lenticule can be removed to correct the refractive error by tissue subtraction. In ReLEx® smile, the lenticule is dissected and removed through a small 2-3mm incision without the need to create a whole flap.

The aims are i) to optimize the VisuMax settings for lenticule separation ii) to optimize the lenticule geometry iii) to assess the safety, efficacy and stability of the treatment

Enrollment: 220 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• older than 21 years of age,

• maximum hyperopic meridian between +1.00D and +7.00D

• astigmatism up to 6D

• CDVA of:

  1. 20/200 or worse in the eye(s) being treated for Phase I
  2. Between 20/200 and 20/100 in the eye(s) being treated for Phase II
  3. Between 20/40 and 20/60 in the eye(s) being treated for Phase III
  4. 20/25 or better for Phase IV

• total uncut stromal thickness of more than 300 µm

• no previous refractive surgery,

• no ocular disease,

• normal corneal topography,

• contact lens wearers have to stop wearing hard contact lenses at least 4 weeks and soft contact lenses 2 weeks prior to pre-examination,

• willing to attend follow-up examinations within the scope of the clinical investigation,

• able and willing to sign the informed consent

Exclusion criteria

• patients who are not being able to lie flat in a horizontal position,
• patients who are not being able to understand and give informed consent,
• pregnant or nursing women (or women who are planning to became pregnant during the clinical investigation),
• diagnosis of an autoimmune disease (e.g. AIDS), connective tissue disease or diabetes,
• treatment with medications such as steroids or immune-suppressants,
• herpes simplex or herpes zoster keratitis,
• all standard medical exclusion criteria for LASIK

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 1 patient group

Small incision lenticule extraction

Experimental group

Description:

Small incision lenticule extraction (SMILE) is a form of corneal laser refractive surgery performed using a femtosecond laser

Treatment:

Device: ReLEx® (SMILE)

Procedure: Small incision lenticule extraction