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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
220
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.
Tilganga Institute of Ophthalmology, Refractive Surgery Unit
Kathmandu, Nepal
RECRUITINGSafety 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.
Time frame: 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.
Time frame: 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
Time frame: 1 year
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)
Time frame: 1 year
Optical zone diameter
Measure the achieved optical zone diameter from tangential curvature difference maps relative to the intended optical zone
Time frame: 1 year
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