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

NCT02316041 | Unknown

• 1 other identifier: 177/2013
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Keywords

Femtosecond laser; Small incision lenticule extraction (SMILE)

Outcome Measures

Primary Outcomes (3)

• Safety of corrected distance visual acuity (change in corrected distance visual acuity)

  Assess the change in corrected distance visual acuity (CDVA) before and after the SMILE procedure.

  1 year

• Efficacy of uncorrected distance visual acuity (uncorrected distance visual acuity achieved after the SMILE procedure relative to the preoperative CDVA)

  Measure the uncorrected distance visual acuity achieved after the SMILE procedure relative to the preoperative CDVA for all eyes where the intended target refraction was emmetropia.

  1 year

• Predictability of refractive outcome ( change in manifest refractive error)

  Measure the change in manifest refractive error (sphere, cylinder, spherical equivalent) after the SMILE procedure and analyze the predictability relative to the intended target refraction as well as the refractive stability over the 1 year follow-up period

  1 year

Secondary Outcomes (2)

• Optical zone centration (Measure the achieved centration of the optical zone)

  1 year

• Optical zone diameter

  1 year

Study Arms (1)

Small incision lenticule extraction

EXPERIMENTAL

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

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

Interventions

Small incision lenticule extraction 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.

Also known as: SMILE, Refractive lenticule extraction, ReLEx

Small incision lenticule extraction

ReLEx® (SMILE) DEVICE

Small incision lenticule extraction

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 21 years of age,
• maximum hyperopic meridian between +1.00D and +7.00D
• astigmatism up to 6D
• CDVA of:
• /200 or worse in the eye(s) being treated for Phase I
• Between 20/200 and 20/100 in the eye(s) being treated for Phase II
• Between 20/40 and 20/60 in the eye(s) being treated for Phase III
• /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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Tilganga Institute of Ophthalmology: lead
• London Vision Clinic: collaborator

Study Sites (1)

Tilganga Institute of Ophthalmology, Refractive Surgery Unit

Kathmandu, Nepal

RECRUITING

Related Publications (1)

• 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.

  PMID: 22695934 BACKGROUND

MeSH Terms

Conditions

Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Kishore R Pradhan, MD

  Tilganga Institute of Ophthalmology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kishore R Pradhan, MD

CONTACT

009779803397021; drkishoreraj@hotmail.com

Govinda Ojha

CONTACT

ojhagovinda@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 12, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2018
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

NE (1)