Spectacles for Lazy Eye

(SPECTRA Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Benjamin Thompson, PhD

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{11 12 13 14 15}

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

Eligibility 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.

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

Treatment Details

Interventions

• Optical Correction (Refractive 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.

Participant Groups

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+

Dr. Loretta Fong

The Hong Kong Polytechnic University

Chief Medical Officer since 2023

MD from the University of Hong Kong

Prof. Jin-Guang Teng

The Hong Kong Polytechnic University

Chief Executive Officer since 2019

PhD in Structural Engineering from the University of Sydney

University of Waterloo

Collaborator

Trials

132

Recruited

221,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Comparison between over-glasses patching and adhesive patching for children with moderate amblyopia: a prospective randomized clinical trial. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Monovision slows juvenile myopia progression unilaterally. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Remediation of refractive amblyopia by optical correction alone. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

[Optimization of an individualized LASIK surgery. Geometric ray tracing model]. [2006]

5. England pubmed.ncbi.nlm.nih.gov

Accommodation and its role in myopia progression and control with soft contact lenses. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Safety of soft contact lenses in children: retrospective review of six randomized controlled trials of myopia control. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Corneal Infections Associated with Sleeping in Contact Lenses - Six Cases, United States, 2016-2018. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Incidence of Intraoperative and Early Postoperative Adverse Events in a Large Cohort of Consecutive Laser Vision Correction Treatments. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Contact Lens Safety for the Correction of Refractive Error in Healthy Eyes. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

MiSight Assessment Study Spain: Adverse Events, Tear Film Osmolarity, and Discontinuations. [2018]

11. France pubmed.ncbi.nlm.nih.gov

[Correction of presbyopia in users of video terminals by progressive half-spectacles]. [2006]

12. England pubmed.ncbi.nlm.nih.gov

Vision tests on spectacle lenses and contact lenses for optical myopia correction: a pilot study. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Mechanical design of a power-adjustable spectacle lens frame. [2019]

14. Brazil pubmed.ncbi.nlm.nih.gov

[Preliminary results of an algorithm for customized soft contact lens ablation]. [2019]

15. Romania pubmed.ncbi.nlm.nih.gov

[The therapeutic contact lens--advantages and limits]. [2006]