ClinicalTrials.gg
CompletedNCT05394987SPECTRAUpdated Oct 27, 2026

Optical Correction and Visual Functions of Adults With Amblyopia

An interventional study of Spectacles in Amblyopia, sponsored by Centre for Eye and Vision Research. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Centre for Eye and Vision Research · Not applicable, Interventional, and Treatment

Updated Oct 27, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years to 39 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Amblyopia

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Keywords

  • Amblyopia
  • Binocular vision
  • Suppression
  • Plasticity
  • Optical correction
03

In context

Amblyopia

189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.

This study's enrollment of 45 is below the median of 60 across 137 interventional studies indexed under Amblyopia.

Browse Amblyopia studies →

Lead sponsor

Centre for Eye and Vision Research is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Optical correction

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

    Device: Spectacles

Interventions

  • DeviceSpectacles

    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.

06

What researchers measure

Primary outcomes

  1. Best corrected visual acuity of the amblyopic eye pre-intervention

    The size of the smallest line of letters read accurately on an ETDRS chart.

    Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)

  2. Best corrected visual acuity of the amblyopic eye post-intervention

    The size of the smallest line of letters read accurately on an ETDRS chart.

    Time frame: Approx. 5 mins, on completion of study (week 24)

Secondary outcomes

  1. Best corrected visual acuity of the amblyopic eye during intervention

    The size of the smallest line of letters read accurately on an ETDRS chart.

    Time frame: Approx. 5 mins, every 4 weeks from start of intervention

  2. Fellow eye distance visual acuity pre-intervention

    The size of the smallest line of letters read accurately on an ETDRS chart.

    Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)

  3. Fellow eye distance visual acuity post-intervention

    The size of the smallest line of letters read accurately on an ETDRS chart.

    Time frame: Approx. 5 mins, on completion of study (week 24)

  4. Fellow eye distance visual acuity during-intervention

    The size of the smallest line of letters read accurately on an ETDRS chart.

    Time frame: Approx. 5 mins, every 4 weeks from start of intervention

  5. Binocular distance visual acuity pre-intervention

    The size of the smallest line of letters read accurately on an ETDRS chart.

    Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)

  6. Binocular distance visual acuity post-intervention

    The size of the smallest line of letters read accurately on an ETDRS chart.

    Time frame: Approx. 5 mins, on completion of study (week 24)

  7. Binocular distance visual acuity during intervention

    The size of the smallest line of letters read accurately on an ETDRS chart.

    Time frame: Approx. 5 mins, every 4 weeks from start of intervention

  8. Near visual acuity of amblyopic eye pre-intervention

    The size of the smallest line of letters read accurately on a near ETDRS chart.

    Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)

  9. Near visual acuity of amblyopic eye post-intervention

    The size of the smallest line of letters read accurately on a near ETDRS chart.

    Time frame: Approx. 5 mins, on completion of study (week 24)

  10. Near visual acuity of amblyopic eye during intervention

    The size of the smallest line of letters read accurately on a near ETDRS chart.

    Time frame: Approx. 5 mins,every 4 weeks from start of intervention

  11. Near visual acuity of fellow eye pre-intervention

    The size of the smallest line of letters read accurately on a near ETDRS chart.

    Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)

  12. Near visual acuity of fellow eye post-intervention

    The size of the smallest line of letters read accurately on a near ETDRS chart.

    Time frame: Approx. 5 mins, on completion of study (week 24)

  13. Near visual acuity of fellow eye during intervention

    The size of the smallest line of letters read accurately on a near ETDRS chart.

    Time frame: Approx. 5 mins, every 4 weeks from start of intervention

  14. Near binocular visual acuity pre-intervention

    The size of the smallest line of letters read accurately on a near ETDRS chart.

    Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)

  15. Near binocular visual acuity post-intervention

    The size of the smallest line of letters read accurately on a near ETDRS chart.

    Time frame: Approx. 5 mins, on completion of study (week 24)

  16. Near binocular visual acuity during intervention

    The size of the smallest line of letters read accurately on a near ETDRS chart.

    Time frame: Approx. 5 mins, every 4 weeks from start of intervention

  17. Amblyopic eye contrast sensitivity pre-intervention

    Computer-based measurement of contrast sensitivity

    Time frame: Approx. 10 mins, baseline (day 1 of spectacle wear)

  18. Amblyopic eye contrast sensitivity post-intervention

    Computer-based measurement of contrast sensitivity

    Time frame: Approx. 10 mins, on completion of study (week 24)

  19. Amblyopic eye contrast sensitivity during intervention

    Computer-based measurement of contrast sensitivity

    Time frame: Approx. 10 mins, every 4 weeks from start of intervention

  20. Stereopsis pre-intervention

    Smallest disparity on the Randot preschool test reported accurately.

    Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)

  21. Stereopsis post-intervention

    Smallest disparity on the Randot preschool test reported accurately.

    Time frame: Approx. 5 mins, on completion of study (week 24)

  22. Stereopsis during intervention

    Smallest disparity on the Randot preschool test reported accurately.

    Time frame: Approx. 5 mins, every 4 weeks from start of intervention

  23. Angle of strabismus pre-intervention

    Prismatic power required to neutralise the angle of deviation on alternating prism cover test.

    Time frame: Approx. 5 mins,baseline (day 1 of spectacle wear)

  24. Angle of strabismus post-intervention

    Prismatic power required to neutralise the angle of deviation on alternating prism cover test.

    Time frame: Approx. 5 mins, on completion of study (week 24)

  25. Angle of strabismus during intervention

    Prismatic power required to neutralise the angle of deviation on alternating prism cover test.

    Time frame: Approx. 5 mins, every 4 weeks from start of intervention

  26. Amblyopic eye fixation stability pre-intervention

    Eye position recorded with high-speed eye tracker during fixation as quantified by bivariate contour ellipse area (BCEA).

    Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)

  27. Amblyopic eye fixation stability post-intervention

    Eye position recorded with high-speed eye tracker during fixation as quantified by bivariate contour ellipse area (BCEA).

    Time frame: Approx. 5 mins, on completion of study (week 24)

  28. Amblyopic eye fixation stability during intervention

    Eye position recorded with high-speed eye tracker during fixation as quantified by bivariate contour ellipse area (BCEA).

    Time frame: Approx. 5 mins, every 4 weeks from start of intervention

  29. 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).

    Time frame: Approx. 5 mins, baseline (day 1 of spectacle wear)

  30. 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).

    Time frame: Approx. 5 mins, on completion of study (week 24)

  31. 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).

    Time frame: Approx. 5 mins, every 4 weeks from start of intervention

  32. Interocular suppression pre-intervention

    Computer-based measurement of interocular suppression.

    Time frame: Approx. 10 mins, baseline (day 1 of spectacle wear)

  33. Interocular suppression post-intervention

    Computer-based measurement of interocular suppression.

    Time frame: Approx. 10 mins, on completion of study (week 24)

  34. Interocular suppression during intervention

    Computer-based measurement of interocular suppression.

    Time frame: Approx. 10 mins, every 4 weeks from start of intervention

  35. Quality of life pre-intervention

    Questionnaire scores for: 1. Amblyopia and Strabismus Questionnaire 2. World Health Organization Quality of Life-BREF

    Time frame: Approx.15-20 mins, baseline (day 1 of spectacle wear)

  36. Quality of life post-intervention

    Questionnaire scores for: 1. Amblyopia and Strabismus Questionnaire 2. World Health Organization Quality of Life-BREF

    Time frame: Approx. 15-20 mins, on completion of study (week 24)

Other outcomes

  1. Electrical potentials pre-intervention

    Electroencephalography (EEG) measures: Visual evoked potentials for high and low contrast stimuli (monocular: fellow eye and amblyopic eye)

    Time frame: Approx. 60 mins, baseline (day 1 of spectacle wear)

  2. Electrical potentials post-intervention

    Electroencephalography (EEG) measures: Visual evoked potentials for high and low contrast stimuli (monocular: fellow eye and amblyopic eye)

    Time frame: Approx. 60 mins, on completion of study (week 24)

  3. Electrical potentials during intervention

    Electroencephalography (EEG) measures: Visual evoked potentials for high and low contrast stimuli (monocular: fellow eye and amblyopic eye)

    Time frame: Approx. 60 mins, 12 weeks from baseline (day 1 of spectacle wear)

07

Study locations

2 sites
  • University of Waterloo
    Waterloo, Ontario N2L 3G1, Canada
  • Centre for Eye and Vision Research Limited
    Hong Kong, Guangdong 00000, Hong Kong
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes — Anonymized data will be shared on request

Supporting information: Study protocol, Statistical analysis plan

Time frame: After publication of study results for an indefinite period.

Access criteria: Upon reasonable request and approved by the study principal investigator.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Oct 27, 2026
Primary completion
Nov 30, 2026→Jun 1, 2026 (actual)
Oct 27, 2026
Study completion
May 31, 2027→Jun 1, 2026 (actual)
Oct 27, 2026
Enrollment
36 (estimated)→45 (actual)
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Recruiting→Completed
    Primary completion Nov 30, 2026→Jun 1, 2026 (now actual)
    Study completion May 31, 2027→Jun 1, 2026 (now actual)
    Enrollment 36 (estimated)→45 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05394987
Lead sponsor
Centre for Eye and Vision Research
Collaborators
The Hong Kong Polytechnic University, University of Waterloo
Responsible party
Sponsor
First posted
May 27, 2022
Start date
Jun 13, 2022
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026
Last update
Oct 27, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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