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

NCT ID: NCT02316041

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31

Brief Summary

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

Conditions

Hyperopia

Study Design

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

Study Groups

Small incision lenticule extraction

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

Group Type: EXPERIMENTAL

Small incision lenticule extraction

Intervention Type: PROCEDURE

The VisuMax femtosecond laser is used to create two interfaces that define a refractive lenticule of stromal tissue and a 2mm wide tunnel to connect the upper layer to the corneal surface. The lenticule is manually dissected and removed through the small 2mm incision without the need to create a flap as in LASIK.

ReLEx® (SMILE)

Intervention Type: DEVICE

Interventions

Small incision lenticule extraction

The VisuMax femtosecond laser is used to create two interfaces that define a refractive lenticule of stromal tissue and a 2mm wide tunnel to connect the upper layer to the corneal surface. The lenticule is manually dissected and removed through the small 2mm incision without the need to create a flap as in LASIK.

Intervention Type: PROCEDURE

ReLEx® (SMILE)

Intervention Type: DEVICE

Other Intervention Names

SMILE; Refractive lenticule extraction; ReLEx

Eligibility Criteria

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,

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

London Vision Clinic

OTHER

Sponsor Role: collaborator

Tilganga Institute of Ophthalmology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kishore R Pradhan, MD

Role: PRINCIPAL_INVESTIGATOR

Tilganga Institute of Ophthalmology

Locations

Tilganga Institute of Ophthalmology, Refractive Surgery Unit

Kathmandu, , Nepal

Site Status: RECRUITING

Countries

Nepal

Central Contacts

Kishore R Pradhan, MD

Role: CONTACT

drkishoreraj@hotmail.com

009779803397021

Govinda Ojha

Role: CONTACT

ojhagovinda@hotmail.com

Facility Contacts

Govinda Ojha

Role: primary

ojhagovinda@hotmail.com

References

Blum M, Kunert KS, Vossmerbaumer U, Sekundo W. Femtosecond lenticule extraction (ReLEx) for correction of hyperopia - first results. Graefes Arch Clin Exp Ophthalmol. 2013 Jan;251(1):349-55. doi: 10.1007/s00417-012-2064-y. Epub 2012 Jun 14.

Reference Type: BACKGROUND

PMID: 22695934 (View on PubMed)

Other Identifiers

177/2013

Identifier Type: -

Identifier Source: org_study_id