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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: Tilganga Institute of Ophthalmology

Current Primary Outcome:

• Safety of corrected distance visual acuity (change in corrected distance visual acuity) [ Time Frame: 1 year ]
  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 ]
  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 ]
  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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Optical zone centration (Measure the achieved centration of the optical zone) [ Time Frame: 1 year ]
  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 ]
  Measure the achieved optical zone diameter from tangential curvature difference maps relative to the intended optical zone

Original Secondary Outcome: Same as current

Information By: Tilganga Institute of Ophthalmology

Dates:
Date Received: December 9, 2014
Date Started: January 2014
Date Completion:
Last Updated: May 2, 2017
Last Verified: May 2017