Optical Correction and Visual Functions of Adults With Amblyopia

Официальное название

Spectacle Correction for the Treatment of Amblyopia

Обзор

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.

Вмешательства

• Устройство 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. Anisometro

Первичные конечные точки

• Best corrected visual acuity of the amblyopic eye pre-intervention [Срок оценки: Approx. 5 mins, baseline (day 1 of spectacle wear)]
• Best corrected visual acuity of the amblyopic eye post-intervention [Срок оценки: Approx. 5 mins, on completion of study (week 24)]

Вторичные конечные точки (12)

• Best corrected visual acuity of the amblyopic eye during intervention [Срок оценки: Approx. 5 mins, every 4 weeks from start of intervention]
• Fellow eye distance visual acuity pre-intervention [Срок оценки: Approx. 5 mins, baseline (day 1 of spectacle wear)]
• Fellow eye distance visual acuity post-intervention [Срок оценки: Approx. 5 mins, on completion of study (week 24)]
• Fellow eye distance visual acuity during-intervention [Срок оценки: Approx. 5 mins, every 4 weeks from start of intervention]
• Binocular distance visual acuity pre-intervention [Срок оценки: Approx. 5 mins, baseline (day 1 of spectacle wear)]
• Binocular distance visual acuity post-intervention [Срок оценки: Approx. 5 mins, on completion of study (week 24)]
• Binocular distance visual acuity during intervention [Срок оценки: Approx. 5 mins, every 4 weeks from start of intervention]
• Near visual acuity of amblyopic eye pre-intervention [Срок оценки: Approx. 5 mins, baseline (day 1 of spectacle wear)]
• Near visual acuity of amblyopic eye post-intervention [Срок оценки: Approx. 5 mins, on completion of study (week 24)]
• Near visual acuity of amblyopic eye during intervention [Срок оценки: Approx. 5 mins,every 4 weeks from start of intervention]
• Near visual acuity of fellow eye pre-intervention [Срок оценки: Approx. 5 mins, baseline (day 1 of spectacle wear)]
• Near visual acuity of fellow eye post-intervention [Срок оценки: Approx. 5 mins, on completion of study (week 24)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• University of Waterloo — Waterloo

Гонконг · 1 центр

• Centre for Eye and Vision Research Limited — Гонконг

Публикации

• 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. PMID 38950991

Идентификаторы

NCT: NCT05394987 · SPECTRA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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