Use of a Disk of Amniotic Membrane (Visio-AMTRIX) in Postoperative Care After PKR
MyopiaAstigmatism1 moreThe purpose of this open controlled multicenter trial is to assess the impact of use of an amniotic membrane on post PKR recovery.
Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia...
HypermetropiaThe correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation. The objective is to evaluate the safety and effectiveness.
A Phase 1/2 Crossover Study to Assess EXP039 for Myopia or Hyperopia
HyperopiaMyopiaAssess the Safety, Pharmacodynamics, and Efficacy of EXP039 Ophthalmic Solution in Participants with Myopia or Hyperopia
Clinical Trial of the Femtosecond Laser System VisuMax for Refractive Correction of Hyperopia by...
HyperopiaThis 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
Intrastromal Correction of Ametropia by a Femtosecond Laser
PresbyopiaMyopia2 moreThis study evaluates the intrastromal correction of ametropia with a femtosecond laser made by 20/10 PERFECT VISION. This laser generates a beam of ultrashort, infrared pulses which enables very precise cuts in the cornea. By these cuts lamellae of the cornea are separated locally, and in the consequence the curvature of the cornea is changed, and the correction of the diagnosed ametropia can be achieved. On the contrary to cuts which are generated with a sharp knife, the cuts generated when using a laser can be generated just inside the cornea without opening the surface of the cornea. This means the procedure is minimal-invasive. The study hypothesis is: Different types of ametropia can be corrected safely and on long-term by intrastromal cuts.
PiXL for Correction of Hyperopia
HyperopiaThis clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.
A Prospective Safety and Effectiveness Study of a New High Repetition Rate Excimer Laser Using LASIK...
MyopiaHyperopia1 moreThis clinical study has been planned to evaluate the safety and effectiveness of common treatment algorithms using 500 Hz laser repetition rate for the correction of Ammetropia and Presbyopia
A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser...
MyopiaHyperopia1 moreThis clinical study has been planned to evaluate the safety and effectiveness of common treatment algorithms using 500 Hz laser repetition rate.
Randomized, Non-inferiority Trial Comparing SMILE and LASIK
MyopiaAstigmatism1 moreBackground: Small Incision Lenticule Extraction or SMILE is a novel form of 'flapless' corneal refractive surgery that was adapted from Refractive Lenticule Extraction (ReLEx). SMILE uses only one femtosecond laser to complete the refractive surgery, potentially reducing surgical time, side effects and cost. If successful, SMILE could potentially replace the current, widely practiced Laser In-situ Keratomileusis or LASIK. The aim of this study is to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes at 3-months post-operatively. Methods/ Design: Single tertiary center, parallel group, single-blinded, paired-eye design, non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will be enrolled for study after informed consent. Each participant will be randomized to receive SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> -3.00D) at a tertiary eye center in terms of refractive predictability at 3 months post-operatively. Our secondary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> -3.00D) at a tertiary eye center in terms of other refractive outcomes (efficacy, safety, higher-order aberrations) at 3 months post-operatively. Our primary outcome is refractive predictability, which is one of several standard refractive outcomes, defined as the proportion of eyes achieving a postoperative spherical equivalent (SE) within ±0.50 diopter (D) of the intended target. Randomization will be performed using random allocation sequence generated by a computer with no blocks or restrictions, and implemented by concealing the number-coded surgery within sealed envelopes until just before the procedure. In this single-blinded trial, subjects and their caregivers will be blinded to the assigned treatment in each eye. Discussion: This novel trial will provide information on whether SMILE has comparable, if not superior, refractive outcomes compared to the established LASIK for myopia, thus providing evidence for translation into clinical practice.
A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser...
MyopiaHyperopiaThis clinical study has been planned to evaluate the safety and effectiveness of a common treatment algorithms (Proscan) using 500 Hz laser repetition rate.