AmblyopiaSPECTRANCT05394987
Optical Correction and Visual Functions of Adults With Amblyopia
A study testing Spectacles in people with Amblyopia, run by Centre for Eye and Vision Research at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia
- What is being tested?
- Spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Jun 2022to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-39 (inclusive) years of age
- 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
Who cannot join
- Other pathological ocular anomalies known to cause reduced visual acuity
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Hong Kong1 site
Centre for Eye and Vision Research Limited
Hong Kong, Guangdong, 00000
About this study
Official title: Spectacle Correction for the Treatment of Amblyopia
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.
- Conditions
- Amblyopia
- Being tested
- Spectacles
- Keywords
- Amblyopia, Binocular vision, Suppression, Plasticity, Optical correction
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpectaclesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Optical correction | Experimental | Prescription of spectacles for full-time wear to correct refractive error Receives: Device: Spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity of the amblyopic eye pre-intervention
The size of the smallest line of letters read accurately on an ETDRS chart.
Measured: Approx. 5 mins, baseline (day 1 of spectacle wear)
Best corrected visual acuity of the amblyopic eye post-intervention
The size of the smallest line of letters read accurately on an ETDRS chart.
Measured: Approx. 5 mins, on completion of study (week 24)
Secondary outcomes (36)
Best corrected visual acuity of the amblyopic eye during intervention
The size of the smallest line of letters read accurately on an ETDRS chart.
Measured: Approx. 5 mins, every 4 weeks from start of intervention
Fellow eye distance visual acuity pre-intervention
The size of the smallest line of letters read accurately on an ETDRS chart.
Measured: Approx. 5 mins, baseline (day 1 of spectacle wear)
Fellow eye distance visual acuity post-intervention
The size of the smallest line of letters read accurately on an ETDRS chart.
Measured: Approx. 5 mins, on completion of study (week 24)
Fellow eye distance visual acuity during-intervention
The size of the smallest line of letters read accurately on an ETDRS chart.
Measured: Approx. 5 mins, every 4 weeks from start of intervention
Binocular distance visual acuity pre-intervention
The size of the smallest line of letters read accurately on an ETDRS chart.
Measured: Approx. 5 mins, baseline (day 1 of spectacle wear)
Binocular distance visual acuity post-intervention
The size of the smallest line of letters read accurately on an ETDRS chart.
Measured: Approx. 5 mins, on completion of study (week 24)
Binocular distance visual acuity during intervention
The size of the smallest line of letters read accurately on an ETDRS chart.
Measured: Approx. 5 mins, every 4 weeks from start of intervention
Near visual acuity of amblyopic eye pre-intervention
The size of the smallest line of letters read accurately on a near ETDRS chart.
Measured: Approx. 5 mins, baseline (day 1 of spectacle wear)
Near visual acuity of amblyopic eye post-intervention
The size of the smallest line of letters read accurately on a near ETDRS chart.
Measured: Approx. 5 mins, on completion of study (week 24)
Near visual acuity of amblyopic eye during intervention
The size of the smallest line of letters read accurately on a near ETDRS chart.
Measured: Approx. 5 mins,every 4 weeks from start of intervention
Near visual acuity of fellow eye pre-intervention
The size of the smallest line of letters read accurately on a near ETDRS chart.
Measured: Approx. 5 mins, baseline (day 1 of spectacle wear)
Near visual acuity of fellow eye post-intervention
The size of the smallest line of letters read accurately on a near ETDRS chart.
Measured: Approx. 5 mins, on completion of study (week 24)
Near visual acuity of fellow eye during intervention
The size of the smallest line of letters read accurately on a near ETDRS chart.
Measured: Approx. 5 mins, every 4 weeks from start of intervention
Near binocular visual acuity pre-intervention
The size of the smallest line of letters read accurately on a near ETDRS chart.
Measured: Approx. 5 mins, baseline (day 1 of spectacle wear)
Near binocular visual acuity post-intervention
The size of the smallest line of letters read accurately on a near ETDRS chart.
Measured: Approx. 5 mins, on completion of study (week 24)
Near binocular visual acuity during intervention
The size of the smallest line of letters read accurately on a near ETDRS chart.
Measured: Approx. 5 mins, every 4 weeks from start of intervention
Amblyopic eye contrast sensitivity pre-intervention
Computer-based measurement of contrast sensitivity
Measured: Approx. 10 mins, baseline (day 1 of spectacle wear)
Amblyopic eye contrast sensitivity post-intervention
Computer-based measurement of contrast sensitivity
Measured: Approx. 10 mins, on completion of study (week 24)
Amblyopic eye contrast sensitivity during intervention
Computer-based measurement of contrast sensitivity
Measured: Approx. 10 mins, every 4 weeks from start of intervention
Stereopsis pre-intervention
Smallest disparity on the Randot preschool test reported accurately.
Measured: Approx. 5 mins, baseline (day 1 of spectacle wear)
Stereopsis post-intervention
Smallest disparity on the Randot preschool test reported accurately.
Measured: Approx. 5 mins, on completion of study (week 24)
Stereopsis during intervention
Smallest disparity on the Randot preschool test reported accurately.
Measured: Approx. 5 mins, every 4 weeks from start of intervention
Angle of strabismus pre-intervention
Prismatic power required to neutralise the angle of deviation on alternating prism cover test.
Measured: Approx. 5 mins,baseline (day 1 of spectacle wear)
Angle of strabismus post-intervention
Prismatic power required to neutralise the angle of deviation on alternating prism cover test.
Measured: Approx. 5 mins, on completion of study (week 24)
Angle of strabismus during intervention
Prismatic power required to neutralise the angle of deviation on alternating prism cover test.
Measured: Approx. 5 mins, every 4 weeks from start of intervention
Amblyopic eye fixation stability pre-intervention
Eye position recorded with high-speed eye tracker during fixation as quantified by bivariate contour ellipse area (BCEA).
Measured: Approx. 5 mins, baseline (day 1 of spectacle wear)
Amblyopic eye fixation stability post-intervention
Eye position recorded with high-speed eye tracker during fixation as quantified by bivariate contour ellipse area (BCEA).
Measured: Approx. 5 mins, on completion of study (week 24)
Amblyopic eye fixation stability during intervention
Eye position recorded with high-speed eye tracker during fixation as quantified by bivariate contour ellipse area (BCEA).
Measured: Approx. 5 mins, every 4 weeks from start of intervention
Fellow (non-amblyopic) eye fixation stability pre-intervention
Eye position recorded with high-speed eye tracker during fixation as quantified by bivariate contour ellipse area (BCEA).
Measured: Approx. 5 mins, baseline (day 1 of spectacle wear)
Fellow (non-amblyopic) eye fixation stability post-intervention
Eye position recorded with high-speed eye tracker during fixation as quantified by bivariate contour ellipse area (BCEA).
Measured: Approx. 5 mins, on completion of study (week 24)
Fellow (non-amblyopic) eye fixation stability during intervention
Eye position recorded with high-speed eye tracker during fixation as quantified by bivariate contour ellipse area (BCEA).
Measured: Approx. 5 mins, every 4 weeks from start of intervention
Interocular suppression pre-intervention
Computer-based measurement of interocular suppression.
Measured: Approx. 10 mins, baseline (day 1 of spectacle wear)
Interocular suppression post-intervention
Computer-based measurement of interocular suppression.
Measured: Approx. 10 mins, on completion of study (week 24)
Interocular suppression during intervention
Computer-based measurement of interocular suppression.
Measured: Approx. 10 mins, every 4 weeks from start of intervention
Quality of life pre-intervention
Questionnaire scores for:
- Amblyopia and Strabismus Questionnaire
- World Health Organization Quality of Life-BREF
Measured: Approx.15-20 mins, baseline (day 1 of spectacle wear)
Quality of life post-intervention
Questionnaire scores for:
- Amblyopia and Strabismus Questionnaire
- World Health Organization Quality of Life-BREF
Measured: Approx. 15-20 mins, on completion of study (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start13 Jun 2022
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-subject, pre-post interventional study, measuring the effect of optical correction on visual function.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Eye and Vision Research
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University, University of Waterloo
- Responsible party
- Sponsor
- Investigators
- Benjamin Thompson, PhD, Principal investigator, Centre for Eye and Vision Research LimitedKen WS Tan, PhD, Study director, Centre for Eye and Vision Research Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394987
- Sponsor's protocol ID
- SPECTRA
- Acronym
- SPECTRA
- Status last verified
- Oct 2026
- First submitted
- 19 May 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be shared on request
Publications
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.
PubMed 38950991
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectacle Correction for the Treatment of Amblyopia
- ClinicalTrials.gov ID
- NCT05394987
- Acronym / sponsor ID
- SPECTRA / SPECTRA
- Conditions
- Amblyopia
- Keywords
- Amblyopia, Binocular vision, Suppression, Plasticity, Optical correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre for Eye and Vision ResearchUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University, University of Waterloo
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-subject, pre-post interventional study, measuring the effect of optical correction on visual function.
| Arm | Type | Receives |
|---|---|---|
| Optical correction | Experimental | Device: SpectaclesPrescription of spectacles for full-time wear to correct refractive error |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-39 (inclusive) years of age
- 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
Key exclusion criteria (11 listed)
- Other pathological ocular anomalies known to cause reduced visual acuity
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpectaclesPrescription 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. | Device | Optical correction |
Primary outcome
Best corrected visual acuity of the amblyopic eye pre-intervention
Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)
The size of the smallest line of letters read accurately on an ETDRS chart.
Best corrected visual acuity of the amblyopic eye post-intervention
Time frame: Approx. 5 mins, on completion of study (week 24)
The size of the smallest line of letters read accurately on an ETDRS chart.
36 secondary outcomes
Best corrected visual acuity of the amblyopic eye during intervention
Time frame: Approx. 5 mins, every 4 weeks from start of intervention
Fellow eye distance visual acuity pre-intervention
Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)
Fellow eye distance visual acuity post-intervention
Time frame: Approx. 5 mins, on completion of study (week 24)
Fellow eye distance visual acuity during-intervention
Time frame: Approx. 5 mins, every 4 weeks from start of intervention
Binocular distance visual acuity pre-intervention
Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)
Binocular distance visual acuity post-intervention
Time frame: Approx. 5 mins, on completion of study (week 24)
Binocular distance visual acuity during intervention
Time frame: Approx. 5 mins, every 4 weeks from start of intervention
Near visual acuity of amblyopic eye pre-intervention
Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)
Near visual acuity of amblyopic eye post-intervention
Time frame: Approx. 5 mins, on completion of study (week 24)
Near visual acuity of amblyopic eye during intervention
Time frame: Approx. 5 mins,every 4 weeks from start of intervention
Near visual acuity of fellow eye pre-intervention
Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)
Near visual acuity of fellow eye post-intervention
Time frame: Approx. 5 mins, on completion of study (week 24)
Near visual acuity of fellow eye during intervention
Time frame: Approx. 5 mins, every 4 weeks from start of intervention
Near binocular visual acuity pre-intervention
Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)
Near binocular visual acuity post-intervention
Time frame: Approx. 5 mins, on completion of study (week 24)
Near binocular visual acuity during intervention
Time frame: Approx. 5 mins, every 4 weeks from start of intervention
Amblyopic eye contrast sensitivity pre-intervention
Time frame: Approx. 10 mins, baseline (day 1 of spectacle wear)
Amblyopic eye contrast sensitivity post-intervention
Time frame: Approx. 10 mins, on completion of study (week 24)
Amblyopic eye contrast sensitivity during intervention
Time frame: Approx. 10 mins, every 4 weeks from start of intervention
Stereopsis pre-intervention
Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)
Stereopsis post-intervention
Time frame: Approx. 5 mins, on completion of study (week 24)
Stereopsis during intervention
Time frame: Approx. 5 mins, every 4 weeks from start of intervention
Angle of strabismus pre-intervention
Time frame: Approx. 5 mins,baseline (day 1 of spectacle wear)
Angle of strabismus post-intervention
Time frame: Approx. 5 mins, on completion of study (week 24)
Angle of strabismus during intervention
Time frame: Approx. 5 mins, every 4 weeks from start of intervention
Amblyopic eye fixation stability pre-intervention
Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)
Amblyopic eye fixation stability post-intervention
Time frame: Approx. 5 mins, on completion of study (week 24)
Amblyopic eye fixation stability during intervention
Time frame: Approx. 5 mins, every 4 weeks from start of intervention
Fellow (non-amblyopic) eye fixation stability pre-intervention
Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)
Fellow (non-amblyopic) eye fixation stability post-intervention
Time frame: Approx. 5 mins, on completion of study (week 24)
Fellow (non-amblyopic) eye fixation stability during intervention
Time frame: Approx. 5 mins, every 4 weeks from start of intervention
Interocular suppression pre-intervention
Time frame: Approx. 10 mins, baseline (day 1 of spectacle wear)
Interocular suppression post-intervention
Time frame: Approx. 10 mins, on completion of study (week 24)
Interocular suppression during intervention
Time frame: Approx. 10 mins, every 4 weeks from start of intervention
Quality of life pre-intervention
Time frame: Approx.15-20 mins, baseline (day 1 of spectacle wear)
Quality of life post-intervention
Time frame: Approx. 15-20 mins, on completion of study (week 24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Derived from this study: PubMed 38950991Tan 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.
- Individual participant dataSharing planned: Yes. Anonymized data will be shared on request
Related trials for Amblyopia
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
RecruitingPhase 3
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Amblyopia
RecruitingPhase 3
Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Amblyopia
Recruiting
OCT Eccentric Fixation and Amblyopia in Children
Amblyopia
Not yet recruiting
Non-invasive Induction of Metaplasticity for Amblyopia
Amblyopia, Amblyopia Unilateral
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Thompson, PhD principal investigator
Centre for Eye and Vision Research Limited
Ken WS Tan, PhD study director
Centre for Eye and Vision Research Limited
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectacles in people with Amblyopia, run by Centre for Eye and Vision Research at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity of the amblyopic eye pre-intervention (time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05394987, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.