Spectacles for Lazy Eye
(SPECTRA Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Centre for Eye and Vision Research
Disqualifiers: Presbyopia, Bilateral amblyopia, Psychiatric disorders, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Amblyopia is a developmental anomaly resulting from abnormal visual experiences in early life. Amblyopia causes reduced visual acuity in the absence of a pathology. Adult sensory systems are believed to be structurally invariant beyond early, critical periods of development. However, recent evidence suggest that visual functions in adults with amblyopia can be improved with optical correction alone. This study aims to investigate whether improvements in best corrected visual acuity and other visual functions can result following appropriate optical correction in adults with amblyopia. Functional measures relating to vision, binocular vision, and eye movements will be used to assess the efficacy of refractive correction for improving vision. This study will help us better understand the improvements in visual functions following optical correction, as well as the mechanisms underlying neuroplasticity in adults with amblyopia.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment for lazy eye using spectacles, optical correction, refractive correction, glasses, and contact lenses?
Research shows that correcting refractive errors with glasses can significantly improve vision in children with amblyopia (lazy eye) over a period of 4-24 weeks. This suggests that using spectacles or contact lenses to correct vision can be an effective part of treating lazy eye.
12345Is wearing spectacles or contact lenses safe for treating lazy eye?
Wearing contact lenses is generally safe for correcting vision problems, but there is a risk of eye infections if they are not used properly, such as sleeping in them. Spectacles (glasses) are a non-invasive option and are considered safe for vision correction.
678910How does the treatment of optical correction for lazy eye differ from other treatments?
Optical correction for lazy eye, using glasses or contact lenses, is unique because it directly addresses vision clarity by correcting refractive errors (issues with how the eye focuses light) without invasive procedures. Unlike other treatments that might involve surgery or eye patches, this method is non-invasive and can be easily adjusted or customized to the individual's needs.
1112131415Eligibility Criteria
This trial is for adults aged 18-39 with 'lazy eye' who have a specific difference in vision strength or astigmatism between their eyes. They must be generally healthy and have not received the optimal glasses prescription yet.Inclusion Criteria
Difference of 1.00D or more between current refractive correction and study prescription
Good general health
I have a significant vision difference between my eyes or both misalignment and vision difference.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-intervention
Baseline measurements including visual acuity, fixation stability, and quality of life assessments
1 day
1 visit (in-person)
Intervention
Participants receive optical correction with spectacles and undergo regular assessments of visual functions
24 weeks
Every 4 weeks (in-person)
Post-intervention
Final assessments of visual acuity, fixation stability, and quality of life
1 day
1 visit (in-person)
Follow-up
Participants are monitored for any long-term changes in visual functions after the intervention
4 weeks
Participant Groups
The study tests if wearing the right spectacles can improve vision in adults with amblyopia (lazy eye). It will measure changes in visual acuity, binocular vision, and eye movements to assess improvement.
1Treatment groups
Experimental Treatment
Group I: Optical correctionExperimental Treatment1 Intervention
Prescription of spectacles for full-time wear to correct refractive error
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of WaterlooWaterloo, Canada
Loading ...
Who Is Running the Clinical Trial?
Centre for Eye and Vision ResearchLead Sponsor
The Hong Kong Polytechnic UniversityCollaborator
University of WaterlooCollaborator
References
Comparison between over-glasses patching and adhesive patching for children with moderate amblyopia: a prospective randomized clinical trial. [2018]To investigate efficacy of over-glasses patching treatment for amblyopic children using visual function improvement and Amblyopia Treatment Index (ATI) changes.
Monovision slows juvenile myopia progression unilaterally. [2018]To evaluate the acceptability, effectivity, and side effects of a monovision spectacle correction designed to reduce accommodation and myopia progression in schoolchildren.
Remediation of refractive amblyopia by optical correction alone. [2019]Amblyopia--the commonest vision abnormality of childhood--is characterized by a loss of visual acuity usually of one eye only. Treatment aims to promote function of the amblyopic eye and does this by restricting, usually through occlusion, the competitive advantage of the fellow eye. Recent experimental evidence demonstrates that the recovery of vision following early deprivation is facilitated by increasing visually evoked activity. An analogous approach in humans is to minimise image blur by correcting refractive error prior to treatment--a practice which may account for the poorly quantified improvements in visual acuity sometimes attributed to 'spectacle adaptation'. Here we describe clinically significant gains in visual acuity obtained over a period of 4-24 weeks in a group of amblyopic children arising solely in response to the correction of refractive error. Consequences for the clinical management of refractive amblyopia are discussed.
[Optimization of an individualized LASIK surgery. Geometric ray tracing model]. [2006]To develop an objective calculation method that is able to provide a customized surgical correction that allows the patient to reach the emmetropia and the maximum visual acuity after the surgery.
Accommodation and its role in myopia progression and control with soft contact lenses. [2019]To examine the impact of contact lens optical design on accommodative behaviour of children and the correlation between myopia progression and the accommodative response of the eye while wearing a contact lens designed for myopia control.
Safety of soft contact lenses in children: retrospective review of six randomized controlled trials of myopia control. [2021]To examine the rate and types of ocular adverse events among children wearing soft contact lenses.
Corneal Infections Associated with Sleeping in Contact Lenses - Six Cases, United States, 2016-2018. [2019]Contact lenses, when worn and cared for properly, are a safe and effective form of vision correction used by an estimated 45 million Americans. However, contact lens wearers are at risk for contact lens-related eye infections, especially when wearers do not practice proper contact lens wear and care habits. These infections, affecting the cornea and known as microbial keratitis (Figure), can lead to serious adverse health outcomes. Because contact lenses are regulated by the Food and Drug Administration (FDA) as medical devices, contact lens-related corneal infections should be reported to FDA as an adverse event. To illustrate their serious health implications, six cases of contact lens-related corneal infection, in which sleeping in lenses was reported as the main risk factor, are presented. Consequences of infection reported among the identified cases included the need for frequent administration of antibiotic eye drops, multiple follow-up medical appointments, and permanent eye damage. Health education measures directed toward contact lens wearers should emphasize raising awareness of the risks of sleeping in contact lenses as well as adherence to all recommendations for the wear and care of contact lenses. Additional measures are needed to educate eye care professionals about the need to report contact lens-related corneal infections to MedWatch, the FDA Safety Information and Adverse Event Reporting program (https://www.fda.gov/MedWatch/).
Incidence of Intraoperative and Early Postoperative Adverse Events in a Large Cohort of Consecutive Laser Vision Correction Treatments. [2020]To evaluate the incidence of adverse events (AE) following laser vision correction.
Contact Lens Safety for the Correction of Refractive Error in Healthy Eyes. [2023]Contact lenses are a safe and effective method for correction of refractive error and worn by an estimated 45 million Americans. Because of the widespread availability and commercial popularity of contact lenses, it is not well appreciated by the public that contact lenses are U.S. Food and Drug Administration (FDA)-regulated medical devices. Contact lenses are marketed in numerous hard and soft materials that have been improved over decades, worn in daily or extended wear, and replaced in range of schedules from daily to yearly or longer. Lens materials and wear and care regimens have impact on the risks of contact lens-related corneal inflammatory events and microbial keratitis. This article reviews contact lens safety, with specific focus on the correction of refractive error in healthy eyes.
MiSight Assessment Study Spain: Adverse Events, Tear Film Osmolarity, and Discontinuations. [2018]To assess the relative clinical success of MiSight contact lenses (CLs) (study group) and distance single-vision (SV) spectacles (control group) in children in terms of adverse events (AEs), discontinuations, and tear film osmolarity over a 2-year period.
[Correction of presbyopia in users of video terminals by progressive half-spectacles]. [2006]Twenty one presbyopes of 48 years old and over (considered as emmetropes or light ametropes), and a young aphakik patient wearing contact lenses, working before visualization screens, were equipped with semi-framed Varilux 2. The correction of their Intermediary Vision was made precisely on the upper edged level of the frame; the correction of their Near Vision was made by an addition of strength reduced by half when compared to the usual graduation. This specific equipment was compared to the classical system of their choice, manufactured at the same time and offering the same strength in Near Vision. This comparative study resulted in the following conclusions which were in most cases: a "normalization" of the distance to the working screen, an improved distinctness of characters in the intermediate and near distances, a very definite improvement of the vertical scanning when alternating between the keyboard and the screen, and of the horizontal scanning when alternating between the keyboard, or the screen, and the documents, an obvious diminution of the time of tiredness, and less stiffness of the neck in its usual working position, the proposed progressive half spectacles remained essentially a working tool, but most participants of this study used them for spare time activities, large professional categories (musicians, painters, etc.), including ours, might benefit from them. The possible benefits obtained from their use by aviators will be published separately. These half-framed progressive spectacles seemed to be the best optical complement to propose to aphakic patients wearing contact lenses and to the pseudophakics.
Vision tests on spectacle lenses and contact lenses for optical myopia correction: a pilot study. [2022]Visual performance and short-term tolerability of different designs of myopia correcting options, including therapeutically relevant bifocal contact lenses (CL) and spectacle lenses with 'defocus incorporated multiple segments (DIMS)' technology were compared.
Mechanical design of a power-adjustable spectacle lens frame. [2019]Power-adjustable spectacle lenses, based on the Alvarez-Lohmann principle, can be used to provide affordable spectacles for subjective refractive errors measurement and its correction. A new mechanical frame has been designed to maximize the advantages of this technology. The design includes a mechanism to match the interpupillary distance with that of the optical centers of the lenses. The frame can be manufactured using low cost plastic injection molding techniques. A prototype has been built to test the functioning of this mechanical design.
[Preliminary results of an algorithm for customized soft contact lens ablation]. [2019]To develop a computer simulation for customized soft contact lenses in order to correct aberrations of higher order.
[The therapeutic contact lens--advantages and limits]. [2006]The therapeutic use is one of the major indications of the contact lenses, near the correction of the refraction.