Optical Correction and Visual Functions of Adults With Amblyopia
NCT ID: NCT05394987
Last Updated: 2024-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
36 participants
INTERVENTIONAL
2022-06-13
2027-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Perceptual Learning Treatment for Amblyopia
NCT03788031
Anisometropia Amblyopia Improved by Perceptual Learning and Patching
NCT00498641
Peripheral Optics in Myopia and Orthokeratology
NCT00978679
Standard Amblyopia Therapy in Adult Amblyopes
NCT03341780
Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia
NCT02970708
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Optical correction
Prescription of spectacles for full-time wear to correct refractive error
Spectacles
Prescription of refractive error correction in spectacles. Refractive error to be determined as part of standard optometric eye exam (performed by registered optometrist).
Guidelines for optical correction for the prescription of the study spectacles (based on Pediatric Eye Disease Investigator Group \[PEDIG\] amblyopia clinical trial protocols): Hypermetropia: not undercorrected by \>+1.50D spherical equivalent and the reduction in plus sphere must be identical between the two eyes. Anisometropia: full correction of the anisometropic difference. Astigmatism: cylinder power in each eye should be within ≤±0.50D of fully correcting the astigmatism for each eye. If cylinder power is ≥1.00D, the prescribed axis in both eyes should be within ≤±6 deg of the cycloplegic refraction axis.
Appropriate refractive error correction will be prescribed. Participants will be instructed to wear the optical correction full-time (i.e., \>50% of waking hours) for the duration of the study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Spectacles
Prescription of refractive error correction in spectacles. Refractive error to be determined as part of standard optometric eye exam (performed by registered optometrist).
Guidelines for optical correction for the prescription of the study spectacles (based on Pediatric Eye Disease Investigator Group \[PEDIG\] amblyopia clinical trial protocols): Hypermetropia: not undercorrected by \>+1.50D spherical equivalent and the reduction in plus sphere must be identical between the two eyes. Anisometropia: full correction of the anisometropic difference. Astigmatism: cylinder power in each eye should be within ≤±0.50D of fully correcting the astigmatism for each eye. If cylinder power is ≥1.00D, the prescribed axis in both eyes should be within ≤±6 deg of the cycloplegic refraction axis.
Appropriate refractive error correction will be prescribed. Participants will be instructed to wear the optical correction full-time (i.e., \>50% of waking hours) for the duration of the study.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Anisometropic amblyopia (difference of ≥0.50D spherical equivalent or ≥1.50D astigmatism between eyes) or mixed mechanism amblyopia (strabismus and anisometropia)
* Best corrected visual acuity (BCVA) in the amblyopic eye of 0.3 logMAR to 1.0 logMAR (inclusive)
* BCVA in the non-amblyopic eye of 0.1 logMAR or better, and an interocular VA difference of 2 logMAR lines or more
* Difference of 1.00D or more between current refractive correction and study prescription
* Good general health
Exclusion Criteria
* Presbyopia (based on amplitude of accommodation)
* Inability to tolerate prescribed refractive correction in spectacles (e.g., due to aniseikonia)
* Contraindication to cycloplegic eye drops
* Currently under amblyopia treatment/therapy
* Inability to comprehend test instructions and/or provide consent
* Eccentric fixation
* \>-6.00DS of myopia in either eye with spectacles
* Bilateral amblyopia
* Presence of amblyopia that is not due to strabismus and/or anisometropia
* Presence of (current or previous) psychiatric, visual, or neurological disorders
18 Years
39 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Hong Kong Polytechnic University
OTHER
University of Waterloo
OTHER
Centre for Eye and Vision Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Benjamin Thompson, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Eye and Vision Research Limited
Ken WS Tan, PhD
Role: STUDY_DIRECTOR
Centre for Eye and Vision Research Limited
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Waterloo
Waterloo, Ontario, Canada
Centre for Eye and Vision Research Limited
Hong Kong, Guangdong, Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Tan KWS, Park ASY, Cheung BWS, Wong GHT, Thompson B; SPECTRA study team. SPEctacle Correction for the TReatment of Amblyopia (SPECTRA): study protocol for a prospective non-randomised interventional trial in adults with anisometropic/mixed mechanism amblyopia. BMJ Open. 2024 Jul 1;14(6):e080151. doi: 10.1136/bmjopen-2023-080151.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPECTRA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.