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

Primary Purpose

Hyperopia

Status
Unknown status
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Small incision lenticule extraction
ReLEx® (SMILE)
Sponsored by
Tilganga Institute of Ophthalmology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperopia focused on measuring Femtosecond laser, Small incision lenticule extraction (SMILE)

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Tilganga Institute of Ophthalmology, Refractive Surgery UnitRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Small incision lenticule extraction

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Optical zone centration (Measure the achieved centration of the optical zone)
Measure the achieved centration of the optical zone by topography relative to the corneal vertex (the intended treatment center)
Optical zone diameter
Measure the achieved optical zone diameter from tangential curvature difference maps relative to the intended optical zone

Full Information

First Posted
December 9, 2014
Last Updated
April 24, 2018
Sponsor
Tilganga Institute of Ophthalmology
Collaborators
London Vision Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02316041
Brief Title
Clinical Trial of the Femtosecond Laser System VisuMax for Refractive Correction of Hyperopia by Means of Lenticule Extraction
Official Title
Clinical Trial of the Femtosecond Laser System VisuMax for Refractive Correction of Hyperopia by Means of Lenticule Extraction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tilganga Institute of Ophthalmology
Collaborators
London Vision Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia
Keywords
Femtosecond laser, Small incision lenticule extraction (SMILE)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Small incision lenticule extraction
Arm Type
Experimental
Arm Description
Small incision lenticule extraction (SMILE) is a form of corneal laser refractive surgery performed using a femtosecond laser
Intervention Type
Procedure
Intervention Name(s)
Small incision lenticule extraction
Other Intervention Name(s)
SMILE, Refractive lenticule extraction, ReLEx
Intervention Description
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
Device
Intervention Name(s)
ReLEx® (SMILE)
Primary Outcome Measure Information:
Title
Safety of corrected distance visual acuity (change in corrected distance visual acuity)
Description
Assess the change in corrected distance visual acuity (CDVA) before and after the SMILE procedure.
Time Frame
1 year
Title
Efficacy of uncorrected distance visual acuity (uncorrected distance visual acuity achieved after the SMILE procedure relative to the preoperative CDVA)
Description
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.
Time Frame
1 year
Title
Predictability of refractive outcome ( change in manifest refractive error)
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Optical zone centration (Measure the achieved centration of the optical zone)
Description
Measure the achieved centration of the optical zone by topography relative to the corneal vertex (the intended treatment center)
Time Frame
1 year
Title
Optical zone diameter
Description
Measure the achieved optical zone diameter from tangential curvature difference maps relative to the intended optical zone
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 20/200 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kishore R Pradhan, MD
Phone
009779803397021
Email
drkishoreraj@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Govinda Ojha
Email
ojhagovinda@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kishore R Pradhan, MD
Organizational Affiliation
Tilganga Institute of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tilganga Institute of Ophthalmology, Refractive Surgery Unit
City
Kathmandu
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Govinda Ojha
Email
ojhagovinda@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
22695934
Citation
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.
Results Reference
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Clinical Trial of the Femtosecond Laser System VisuMax for Refractive Correction of Hyperopia by Means of Lenticule Extraction

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