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75 active trials for Myopia

SEED-LVPEI Myopia Study

This randomized clinical trial study aims to investigate the efficacy of novel SEED's EDOF based mid-lens design in controlling the myopia progression in Indian children with these specific objectives: To investigate the efficacy of SEED's 1-day pure extended depth of focus lenses controlling myopia progression in Indian children through a one-year randomized clinical study. To investigate the role of SEED's 1-day pure extended depth of focus lenses in altering peripheral refraction of the eye to control myopia progression. To determine if there is any specific cohort that shows better efficacy in myopia control with 1-day pure extended depth of focus lenses based on central and peripheral optics (degree of myopia and optical parameters). To investigate the qualitative assessment of comfort and visual experience with the SEED's EDOF contact lenses through the questionnaire method.

Start: December 2020

Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule

The residual hypermetropic refraction on pseudophakic(Trifocal IOL) patients is difficult to treat surgically. In addition, there are not many suitable options to offer such patients presenting with this condition. Two current common surgeries to treat residual hyperopic refraction are refractive lens exchange (RLE) and excimer laser ablation (LASIK or PRK). Laser procedures: Photorefractive keratectomy (PRK); Laser assisted in situ keratomileusis (LASIK); Risks of LASIK include abnormalities of the corneal flap, epithelial ingrowth, corneal ectasia, refractive surprises, irregular astigmatism, decentration, visual aberrations, a loss of BCVA, infectious keratitis, symptoms, and diffuse lamellar keratitis. Refractive lens exchange (RLE); The risks of RLE are similar to those of cataract surgery and include endophthalmitis, a loss of accommodation, vitreous loss with posterior capsular rupture, and retinal detachment. The method used at the EYE Hospital Pristina using fresh lenticule implantation by ReLex-SMILE is safe and effective method, since there is no flap this prevents invasive damage to the anterior surface of the cornea contrary to the LASIK where flap is present posing risk for epithelial ingrowth.

Start: April 2018

Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)

This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary eyes complete 6 months of follow-up. Final study analysis will be assessed when all treated eyes complete 36 months of follow-up.

Start: January 2020

The Effect of Blue-light Filtering Spectacle Lenses on Myopia Progression in Schoolchildren

The purpose of this study is to investigate if the blue-light filtering spectacle lenses promote myopia progression in schoolchildren.

Start: September 2018

Low-Dose Atropine for Treatment of Myopia

Study Objectives The objectives for this randomized trial are: To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment). To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment). Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.

Start: June 2018

Comparing Silicone Hydrogel Contact Lens Wearers to Hydrogel Contact Lens Wearers and Non-lens Wearers

The primary objectives of this study is to to compare baseline data between 3 groups - habitual wearers of DDSH (Daily Disposable Silicone Hydrogel) contact lenses / habitual wearers of DDH (Daily Disposable Hydrogel) contact lenses / non-lens wearers for physiological responses and to compare the physiological responses post closed eye lens wear in 2 groups - habitual wearers of DDSH /habitual wearers of DDH after 3 hours.

Start: May 2021

APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism

Vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the APIOC™ for Presbyopia or the APIOC™ for Presbyopia Astigmatism contact lenses.

Start: May 2021

Eye Length Signal With Myopia Control

Myopia, considered as a global epidemic, is rapidly rising in prevalence especially in east Asian countries. Younger ages are associated with greater annual progression and thus early onset myopia is likely to result in higher levels of final net myopia.[1] Myopia, especially high myopia (more than -6.00D) is associated vision threatening complications such as cataract, glaucoma, choroidal thinning, vitreous liquefaction, myopic maculopathy, retinal detachment etc. Furthermore, myopia can affect the quality of life of an individual through restriction of employment in certain fields such as aviation. Myopia also imposes economic burden through the recurring cost of vision correction such as spectacles, contact lenses and specialist consultation fee. It is therefore important to develop novel optical and pharmaceutical strategies that can control or slow the progression of myopia.

Start: February 2021

Topo-guided LASIK and Photorefractive Keratectomy vs Wavefront LASIK and Photorefractive Keratectomy

This study evaluates the difference in results between eyes that have been treated wavefront optimized laser vision correction (either LASIK or Photorefractive Keratectomy) compared to eyes treated with topography-guided laser vision correction (either LASIK or Photorefractive Keratectomy). Each participant will receive wavefront optimized correction in one eye and topography-guided correction in the other.

Start: February 2017

APIOC Sphere and APIOC Astigmatism

Vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the APIOC™ Sphere or the APIOC™ Astigmatism contact lenses.

Start: March 2021

Characterization of the Corneal Biomechanics of Patients Treated by Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) to Correct Myopia

This study aims to perform biomechanical tests on extracted CLEAR lenticles that are routinely discarded after surgery. The investigators also aim to perform Brillouin microscopy to get an in-vivo assessment of the patient's cornea preoperatively and to correlate this data with the postoperative characterization of the extracted corneal lenticule. The characterization will be done with established biomechanical and morphologic tests.

Start: June 2021

At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults

This study is aimed at examining the BCVA from try-on glasses constructed from measurements from the EyeQue VisionCheck.

Start: April 2021

Low-dose Atropine for the Prevention of Myopia Progression in Danish Children

Myopia (nearsightedness) is increasing in prevalence throughout the world. It is associated with a risk of potentially blinding complications such as retinal detachment and myopic maculopathy. There is a direct association between the degree of myopia and the risk of complications. Myopia develops in childhood and during adolescence. To prevent higher degrees of myopia, we need to halt disease progression in children and teenagers. Low-dose atropine eye drops have been shown to reduce myopia progression by 50% in Asian populations but its effect in non-Asian populations is unknown. The aim of this study is to investigate if low-dose atropine can reduce myopia progression in Danish children and teenagers. The study is an investigator initiated randomized clinical trial conducted as a collaboration between three Danish Eye Departments covering all of Denmark.

Start: May 2019

Part-time Versus Full-time Spectacles for Myopia Control (ParMA Study)

The purpose is to assess the effect of part-time compared to full-time spectacle use in juvenile myopia control.

Start: November 2019

LASIK Surgery With a New Laser for the Treatment of Myopia Without Astigmatism

The AQUARIUZ ablation laser is a solid-state laser and has been CE approved for corneal surgery since March 2020 for the treatment of short- and longsightedness with and without astigmatism. The aim of this study is to collect the first clinical data. Safety and performance are examined here. The treatment with AQUARIUZ is comparable to treatments with an excimer laser, with the difference that these are operated with gas. Solid-state lasers and excimer lasers use the same process for tissue ablation, with a small difference in wavelength. This difference manifests itself in the lower involvement of water in the ablation process with the result of a gentler and safer treatment. Similar to excimer lasers for corneal surgery, the AQAURIUZ system (Ziemer Ophthalmic Systems AG) is equipped with a fast eye tracker (eye tracking system) to correct eye movements during the treatment. The shape of the removed portion of the cornea has an aspherical profile corresponding to the state of the art. The primary objective is to assess the safety of use of the AQUARIUZ corneal ablation laser for LASIK procedures in myopia and myopia with astigmatism. The secondary objective is to compare the predicted visual and refractive outcomes of LASIK procedures using the AQUARIUZ Ablation with clinical data. The study is planned in 3 phases to mitigate the inherent risk of a first in man study and to allow for verification and confirmation of the system correction factor at an early stage.

Start: March 2021

Corneal Topography Asymmetry Indices Changes After Corneal Refractive Surgery

To evaluate the changes that occur in the corneal indices after corneal refractive surgery either PRK or LASIK.

Start: April 2021

Red Light Intervention for Myopia Prevention

To explore the effectiveness of using low-intensity single-wavelength red light to prevent myopia in schoolchildren, and to provide a feasible scheme for reducing the incidence of myopia.

Start: March 2021

Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia

Small Incision Lenticule Extraction (SMILE) was introduced in 2011 using the VISUMAX femtosecond laser (Carl Zeiss Meditec, Jena, Germany). It is designed for correction of myopia and myopic astigmatism. It involves the creation of a corneal tissue disk called lenticule and its extraction through a minimally invasive incision, utilizing only a femtosecond laser. This enables rapid visual recovery with very little discomfort to the patient. This observational case series monitors visual and refractive outcomes of myopic correction for more than -7.75 D. It is to gather long-term results and refractive stability detect rare complications or side-effects evaluate the efficacy in a large number of patients

Start: January 2016

Assessment of Accommodation Behavior in Children Under Myopia Control Treatment (Pilot Study)

This study will examine the accommodative behavior in children undergoing myopia control treatments. A subset of children showing reduced accommodation, known to occur in while wearing multifocal soft contact lenses (MFCL) from previous studies, will undergo auditory biofeedback training to improve the accommodative response and possibly improve treatment efficacy. The results of this study will be used to design a larger clinical trial. Aim 1 - The accommodation response in myopic children being treated with MFCL for six months or longer, will be determined. The accommodative response data will be collected while the patients are wearing the MFCL and will be compared to the baseline control response when the subjects wear single vision soft contact lenses (SVCL). Additional comparisons will include accommodative measures in untreated myopic children wearing spectacle corrections (unttreated controls), children being treated with ortho-keratology contact lenses, and children treated with low-dose atropine (0.01%, considered not to affect accommodation). How these additional myopia treatments affect the accommodation response has yet to be determined. Aim 2 - Children treated with MFCL who show reduced accommodative responses will undergo a brief period of auditory biofeedback accommodative training to determine whether the response in children can be improved and how long it can be sustained. Improving the accommodative response in these patients may improve the treatment efficacy by increasing the effect of the positive power addition built into the lenses.

Start: December 2020

Clinical Study Of Nearsightedness, TReatment With Orthokeratology Lenses 2

Myopia is a common disease of the eye with increasing prevalence all over the world including Denmark where the prevalence has increased from 12,8% in 2004 among young adults (mean age 19,3 years) till 17,9% in 2017 among school children (mean age 15,4 years). High myopia is associated with an increasing risk of sight threatening complications such as retinal detachment, glaucoma, macular choroidal degeneration, and myopic choroidal neovascularization. In myopia the eye is elongated compared to an emmetropic eye. If the elongation of the eye can be controlled the progression of myopia can be controlled. Asian studies have shown reduction in axial length growth by 36-46% in children using orthokeratology contact lenses (OKL). OKL are custom fit, form stable lenses. During sleep the cornea is reshaped creating an emmetropic vision during the day, so no glasses or contact lenses are needed. In the CONTROL-study 60 Danish children aged six to 13 years were randomized 1:1 to either OKL (intervention group) or single vision spectacles (SVS) (control group) and followed for 18 months to compare changes in axial length (AL). In CONTROL2 the intervention group will be followed for another 18 month and the control group will be crossed over to OKL treatment. The aims of CONTROL2 is to: Investigate changes in axial length after 3 years of OKL wear (DreamliteR, Procornea, Nederlands). Investigate changes in progression rate 18 month before and after OKL wear. Investigate correlations between changes in choroidal thickness and changes in AL. Investigate the safety of OKL treatment (Efron score). Investigate changes in quality of life before and after OKL treatment using Pediatric Refractive Error Profile 2 (PREP2). Investigate correlations between AC/A-ratio, peripheral refraction and higher order aberrations on myopia progression.

Start: January 2018