Clinical Trial of the Femtosecond Laser System VisuMax for Refractive Correction of Hyperopia by Means of Lenticule Extraction
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|ClinicalTrials.gov Identifier: NCT02316041|
Recruitment Status : Recruiting
First Posted : December 12, 2014
Last Update Posted : May 3, 2017
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 or disease||Intervention/treatment||Phase|
|Hyperopia||Procedure: Small incision lenticule extraction Device: ReLEx® (SMILE)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial of the Femtosecond Laser System VisuMax for Refractive Correction of Hyperopia by Means of Lenticule Extraction|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2017|
Experimental: Small incision lenticule extraction
Small incision lenticule extraction (SMILE) is a form of corneal laser refractive surgery performed using a femtosecond laser
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:Device: ReLEx® (SMILE)
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316041
|Contact: Kishore R Pradhan, MDemail@example.com|
|Contact: Govinda Ojhafirstname.lastname@example.org|
|Tilganga Institute of Ophthalmology, Refractive Surgery Unit||Recruiting|
|Contact: Govinda Ojha email@example.com|
|Principal Investigator:||Kishore R Pradhan, MD||Tilganga Institute of Ophthalmology|