Spectacles for Lazy Eye

(SPECTRA Trial)

Recruiting at 1 trial location

Overseen By Benjamin Thompson, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Eye and Vision Research

Disqualifiers: Presbyopia, Bilateral amblyopia, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how wearing glasses can improve vision in adults with amblyopia, often called lazy eye. Amblyopia occurs when one eye sees less clearly than the other, not due to disease, but because of differences in vision development. The study aims to determine if wearing the correct glasses (optical correction) can enhance vision and eye function. Adults diagnosed with amblyopia who notice a difference in vision between their eyes may be suitable candidates for this study. As an unphased trial, it offers a unique opportunity to contribute to understanding how glasses can improve vision 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 prior data suggests that optical correction is safe for improving vision in adults with amblyopia?

Research shows that wearing glasses to correct vision problems is generally safe. Glasses commonly improve vision and enhance overall well-being, including mental health and quality of life. For children, the right lenses support learning and development.

For treating amblyopia, or "lazy eye," wearing glasses is crucial. This method improves vision without surgery or other invasive treatments. Studies suggest that wearing the correct glasses can boost productivity by at least 2.5% for those who need them.

No significant reports of serious side effects from wearing glasses exist. This non-invasive option is easy to tolerate. However, following an eye care professional’s advice is important to achieve the best results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using spectacles for lazy eye, or amblyopia, because this approach is straightforward, non-invasive, and targets the root cause of the condition—refractive error. Unlike traditional treatments like patching or atropine drops that focus on forcing the weaker eye to work harder, optical correction through spectacles provides continuous, balanced vision correction. This method could potentially improve adherence and comfort for children, making it a practical and family-friendly option.

What evidence suggests that optical correction is effective for improving vision in adults with amblyopia?

Research shows that wearing glasses can improve vision in people with amblyopia, also known as "lazy eye." Studies have found that when children wear glasses to correct vision problems, their eyesight can improve in just a few weeks. Although most research has focused on children, new findings suggest that adults with amblyopia might also experience improvements by wearing glasses. In this trial, participants will receive optical correction through prescribed spectacles for full-time wear to correct refractive error. Glasses encourage the brain to use the weaker eye more, potentially leading to better vision over time. This approach leverages the brain's ability to change and adapt, even in adulthood. ^{6 7 8 9 10}

Who Is on the Research Team?

Benjamin Thompson, PhD

Principal Investigator

Centre for Eye and Vision Research Limited

Ken WS Tan, PhD

Principal Investigator

Centre for Eye and Vision Research Limited

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Optical Correction

Trial Overview

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.

How Is the Trial Designed?

Group I: Optical correction Experimental Treatment 1 Intervention

Prescription of spectacles for full-time wear to correct refractive error

Who Is Running the Clinical Trial?

Centre for Eye and Vision Research

Lead Sponsor

Trials

3

Recruited

170+

The Hong Kong Polytechnic University

Collaborator

Trials

569

Recruited

78,000+

University of Waterloo

Collaborator

Trials

132

Recruited

221,000+

Published Research Related to This Trial

In a study involving 581 myopic children aged 7-15 years wearing daily disposable hydrogel contact lenses, no significant or serious ocular adverse events were reported over 816 patient years, indicating a high safety profile for these lenses.

The overall rate of ocular adverse events was low at 10.6 per 100 patient years, with only two non-significant corneal infiltrative events, suggesting that daily disposable soft contact lenses are a safe option for children compared to a lower incidence of 1.8 per 100 patient years for spectacle wearers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of soft contact lenses in children: retrospective review of six randomized controlled trials of myopia control. Cheng, X., Brennan, NA., Toubouti, Y., et al.[2021]

Contact lenses are generally safe and effective for vision correction, but improper use, particularly sleeping in them, significantly increases the risk of serious eye infections like microbial keratitis.

Six cases of corneal infections linked to contact lens use highlighted severe consequences, including the need for antibiotics, multiple medical visits, and potential permanent eye damage, underscoring the importance of proper lens care and reporting infections to the FDA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corneal Infections Associated with Sleeping in Contact Lenses - Six Cases, United States, 2016-2018. Cope, JR., Konne, NM., Jacobs, DS., et al.[2019]

Correcting refractive errors in amblyopic children can lead to significant improvements in visual acuity over 4-24 weeks, highlighting the importance of addressing vision issues before other treatments.

This study suggests that minimizing image blur through refractive correction may enhance the effectiveness of amblyopia treatment, potentially changing how clinicians manage refractive amblyopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remediation of refractive amblyopia by optical correction alone. Moseley, MJ., Neufeld, M., McCarry, B., et al.[2019]

In a study involving 8 myopic participants, bifocal contact lenses (MCL) showed a general decrease in visual acuity (VA) and contrast sensitivity (CS) compared to single vision lenses (SV), indicating they may not be as effective for all gaze positions.

The defocus incorporated multiple segments (DIMS) lenses performed similarly to SV lenses at straight gaze (0°), but both DIMS and MCL resulted in decreased VA and CS at nasal and temporal gaze, suggesting that while DIMS can be effective, they may not provide a significant advantage over traditional lenses in all viewing conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision tests on spectacle lenses and contact lenses for optical myopia correction: a pilot study. Kaymak, H., Neller, K., Schütz, S., et al.[2022]

A computer simulation was developed to create customized soft contact lenses that correct higher-order aberrations, specifically for a patient with keratoconus, using precise measurements from a Hartmann-Shack wavefront sensor.

The study successfully calculated the necessary lens thickness and the number of laser pulses required for ablation, indicating a promising approach for improving vision correction, although further refinement is needed for practical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary results of an algorithm for customized soft contact lens ablation]. Matos, Ld., Carvalho, LA.[2019]

In a study of 11-year-old children with myopia, using monovision spectacles resulted in significantly slower myopia progression in the near corrected eye compared to the distance corrected eye, with a difference of 0.36 D/year.

While monovision did not effectively reduce accommodation, it suggests that maintaining myopic defocus can help slow down the axial elongation of the eye, which is a key factor in myopia progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monovision slows juvenile myopia progression unilaterally. Phillips, JR.[2018]

In a study of 109 children aged 8 to 11, wearing a contact lens designed with positive spherical aberration (+SA) led to a significant decrease in accommodative response compared to a control lens, suggesting that the lens design affects how the eye focuses on near objects.

The reduced accommodative response in the +SA lens group was associated with greater myopia progression, indicating that the lens may induce hyperopic defocus at the retina, which could influence the design of future myopia control lenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accommodation and its role in myopia progression and control with soft contact lenses. Cheng, X., Xu, J., Brennan, NA.[2019]

A new objective calculation method for LASIK surgery was developed, which customizes surgical corrections to help patients achieve emmetropia (perfect vision) and maximum visual acuity, based on a study of 187 eyes with myopia or myopic astigmatism.

The method proposes an optimal range for the final corneal radius for each eye, linking the position of this radius to the success of the surgery, thus providing a valuable reference for surgeons to improve their techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optimization of an individualized LASIK surgery. Geometric ray tracing model]. Ortiz, D., Saiz, JM., González, JM., et al.[2006]

Contact lenses are FDA-regulated medical devices that provide a safe and effective way to correct refractive errors for approximately 45 million Americans.

The materials used in contact lenses and the wear and care practices significantly influence the risk of complications, such as corneal inflammation and microbial keratitis, highlighting the importance of proper lens management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contact Lens Safety for the Correction of Refractive Error in Healthy Eyes. Rhee, MK., Jacobs, DS., Dhaliwal, DK., et al.[2023]

In a study of 74 children aged 8 to 12, MiSight contact lenses were found to be a safe option for myopia correction, with no serious or significant adverse events reported over a 2-year period.

While there were some nonsignificant adverse events and a few discontinuations in the MiSight group, the overall safety profile was comparable to that of distance single-vision spectacles, indicating that both options are effective for managing myopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MiSight Assessment Study Spain: Adverse Events, Tear Film Osmolarity, and Discontinuations. Ruiz-Pomeda, A., Pérez-Sánchez, B., Prieto-Garrido, FL., et al.[2018]

In a study involving 107 children aged 3-7 with moderate amblyopia, both adhesive skin patches and over-glasses patches showed similar improvements in visual acuity after 17 weeks, indicating that both methods are effective treatments.

Over-glasses patching is a viable alternative for children who experience discomfort from adhesive patches, as it resulted in less redness of the eye or eyelids, making it a more comfortable option without compromising treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between over-glasses patching and adhesive patching for children with moderate amblyopia: a prospective randomized clinical trial. Kim, SJ., Jeon, H., Jung, JH., et al.[2018]

Power-adjustable spectacle lenses utilizing the Alvarez-Lohmann principle offer a cost-effective solution for measuring and correcting refractive errors in vision.

A newly designed mechanical frame enhances the functionality of these lenses by allowing for adjustment of interpupillary distance, and it can be produced using affordable plastic injection molding techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical design of a power-adjustable spectacle lens frame. Zapata, A., Barbero, S.[2019]

The study involved 21 presbyopic participants aged 48 and older, and a young aphakic patient, who were fitted with semi-framed Varilux 2 spectacles designed to improve intermediate and near vision for screen work.

Results showed significant improvements in visual clarity at various distances, reduced eye strain, and less neck stiffness, suggesting these progressive half spectacles are effective for both professional and leisure activities, particularly for individuals like musicians and painters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Correction of presbyopia in users of video terminals by progressive half-spectacles]. Hamard, H., Chevaleraud, JP., Trubert, E., et al.[2006]

Therapeutic contact lenses (TCL) were found to be effective for 86 patients, providing benefits such as pain relief, improved corneal healing, and enhanced visual acuity while allowing for binocular vision.

While TCLs are generally safe and effective, potential limitations include a risk of infection and issues with lens adaptation in patients with irregular corneas, though complications are rare and typically minor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The therapeutic contact lens--advantages and limits]. Stanila, A., Mihai, E., Saceleanu, A., et al.[2006]

In a study of over 36,000 patients who underwent LASIK and PRK, the incidence of adverse events (AEs) was low, with LASIK showing a 1.3% rate and PRK a 2.3% rate, indicating these procedures are generally safe.

Serious adverse events (SAEs) were also rare, occurring in only 0.4% of LASIK patients and 0.7% of PRK patients, with a very small percentage (0.37%) experiencing a loss of 2 or more lines of corrected distance visual acuity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of Intraoperative and Early Postoperative Adverse Events in a Large Cohort of Consecutive Laser Vision Correction Treatments. Schallhorn, JM., Schallhorn, SC., Teenan, D., et al.[2020]

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK430890/

Amblyopia - StatPearls - NCBI Bookshelf - NIH

Amblyopia is a visual disorder due to the failure of cortical visual development in one or both eyes due to ocular pathology early in life.

2.

withpower.com

withpower.com/trial/phase-amblyopia-4-2022-09a53

Spectacles for Lazy Eye (SPECTRA Trial)

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 ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11034898/

Efficacy of Amblyopia Treatments in Children Up to Seven ...

Spectacle correction was found to be at least as effective or more than patching, with AFG showing additional benefits in CSF and stereoacuity.

4.

cureus.com

cureus.com/articles/386016-evolving-strategies-in-amblyopia-management-from-traditional-therapies-to-cutting-edge-innovations

Evolving Strategies in Amblyopia Management

Amblyopia, or "lazy eye," arises when one eye experiences reduced vision due to the brain favoring the other, leading to weakened visual ...

5.

cookvisiontherapy.com

cookvisiontherapy.com/amblyopia-therapy-vision-training-vs-surgery/

Amblyopia Therapy: Vision Training vs Surgery

Studies show 60-80% success rates for comprehensive lazy eye treatment approaches; Combined vision therapy approaches achieve superior outcomes compared to ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10436410/

The impact of spectacle correction on the well-being of ...

Evidence suggests that spectacle correction improves children's cognitive and educational well-being, psychological well-being, mental health, and quality of ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6494484/

Optical correction of refractive error for preventing and treating ...

It has been estimated that the provision of appropriate refractive correction alone could produce at least a 2.5% increase in productivity among those who use a ...

8.

journals.lww.com

journals.lww.com/aamj/fulltext/2024/01000/visual_and_sensory_outcomes_after_refractive.3.aspx

Visual and sensory outcomes after refractive surgery for...

LASIK and PRK have both been shown in studies to be safe in children. Most published studies included predominantly children aged 7 years and older. Amblyopia ...

9.

aoa.org

aoa.org/aoa/documents/practice%20management/clinical%20guidelines/consensus-based%20guidelines/care%20of%20patient%20with%20amblyopia.pdf

Care of the Patient with Amblyopia

Optical correction, occlusion, and vision therapy are the major treatment options. Untreated amblyopic patients are at a greater risk for loss of vision in the.

10.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1367048417301108

The use of rigid gas permeable contact lenses in children ...

RGP contact lens wear is a safe and effective refractive treatment option in young children with amblyopia due to myopia. Introduction. Amblyopia is a ...