Trial record 2 of 6 for:    Connect mm

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Tilganga Institute of Ophthalmology
Sponsor:
Collaborator:
London Vision Clinic, London, UK
Information provided by (Responsible Party):
Tilganga Institute of Ophthalmology
ClinicalTrials.gov Identifier:
NCT02316041
First received: December 9, 2014
Last updated: December 11, 2014
Last verified: December 2014
  Purpose

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


Condition Intervention
Hyperopia
Procedure: Small incision lenticule extraction
Device: ReLEx® (SMILE)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial of the Femtosecond Laser System VisuMax for Refractive Correction of Hyperopia by Means of Lenticule Extraction

Resource links provided by NLM:


Further study details as provided by Tilganga Institute of Ophthalmology:

Primary Outcome Measures:
  • Safety of corrected distance visual acuity (change in corrected distance visual acuity) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Assess the change in corrected distance visual acuity (CDVA) before and after the SMILE procedure.

  • Efficacy of uncorrected distance visual acuity (uncorrected distance visual acuity achieved after the SMILE procedure relative to the preoperative CDVA) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Predictability of refractive outcome ( change in manifest refractive error) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Optical zone centration (Measure the achieved centration of the optical zone) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Measure the achieved centration of the optical zone by topography relative to the corneal vertex (the intended treatment center)

  • Optical zone diameter [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Measure the achieved optical zone diameter from tangential curvature difference maps relative to the intended optical zone


Estimated Enrollment: 220
Study Start Date: January 2014
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: 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.
    Other Names:
    • SMILE
    • Refractive lenticule extraction
    • ReLEx
    Device: ReLEx® (SMILE)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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,
  • all standard medical exclusion criteria for LASIK
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02316041

Contacts
Contact: Kishore R Pradhan, MD 009779803397021 drkishoreraj@hotmail.com
Contact: Govinda Ojha ojhagovinda@hotmail.com

Locations
Nepal
Tilganga Institute of Ophthalmology, Refractive Surgery Unit Recruiting
Kathmandu, Nepal
Contact: Govinda Ojha       ojhagovinda@hotmail.com   
Sponsors and Collaborators
Tilganga Institute of Ophthalmology
London Vision Clinic, London, UK
Investigators
Principal Investigator: Kishore R Pradhan, MD Tilganga Institute of Ophthalmology
  More Information

Publications:
Responsible Party: Tilganga Institute of Ophthalmology
ClinicalTrials.gov Identifier: NCT02316041     History of Changes
Other Study ID Numbers: 177/2013
Study First Received: December 9, 2014
Last Updated: December 11, 2014
Health Authority: Nepal: Health Research Council

Keywords provided by Tilganga Institute of Ophthalmology:
Femtosecond laser
Small incision lenticule extraction (SMILE)

Additional relevant MeSH terms:
Hyperopia
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on May 03, 2015