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A Randomized Controlled Trial of Gabor-Based Perceptual Learning for Adult Amblyopia

2026年8月9日 更新者:Jiannan Huang

This study is initiated and conducted by the Shanghai Eye Disease Prevention and Treatment Center / Shanghai Eye Hospital. Many people once believed that amblyopia (commonly known as "lazy eye") could only be treated during childhood (the critical period of visual development) and that nothing could be done once we reached adulthood. However, modern visual science research has revealed that the adult visual cortex still retains a certain degree of "neuroplasticity" (the brain's ability to reorganize, learn, and adapt). The Gabor target training used in this study-powered by RevitalVision software-is a scientifically proven visual training program. By repeatedly performing visual tasks near your perception threshold on a computer screen, this training exercises your eye-brain coordination, helping your brain process visual information much more efficiently.

To help you and your family participate with peace of mind, we have compiled the following answers to frequently asked questions:

Q1: How will I participate in this study? What is the difference between the two groups?

To scientifically compare the training's effectiveness, this study uses a rigorous randomized controlled design. A total of 80 eligible participants will be randomly assigned by a computer program in a 1:1 ratio to one of two groups:

Immediate Training Group:

You will begin the 12-week home-based Gabor visual training right after randomization. Your study participation ends after your Week 12 follow-up.

Delayed Training Group:

During the first 12 weeks after randomization, you will simply wear your prescribed glasses and go about your daily life without active visual training.

After completing your Week 12 eye evaluation, you will receive the exact same 12-week Gabor visual training for free (conducted from Week 12 to Week 24).

Please be assured: No matter which group you are assigned to, every eligible participant will ultimately receive the exact same 12-week professional visual training. This "delayed treatment" design is highly ethical. It ensures everyone gets treated while allowing us to compare the two groups transitionally during the first 12 weeks, thereby ruling out other factors like "getting used to the vision charts" or "gradually adjusting to new glasses".

Q2: How is the visual training performed? Is it difficult to do at home?

The training is fully home-based, meaning you do not need to visit the hospital constantly. However, it requires your dedication and, ideally, supervision from your family:

Training Tools: You will use the specialized RevitalVision perceptual learning software on a calibrated computer monitor.

Training Environment: The training should be done in a dark or standard low-light room. Your only main light source should be the computer screen, and you will sit exactly 1.5 meters away.

Glasses & Patching: You must wear your prescribed study glasses during training. If you have monocular (one-sided) amblyopia, you will need to patch your stronger eye (non-study eye), using only your weaker eye (amblyopia eye) to view the screen.

Frequency & Duration: You will train 4 times a week, for about 30 minutes per session, over a continuous span of 12 weeks. The software is adaptive: it automatically adjusts the difficulty of your next session based on your performance to keep you at your optimal training zone.

Q3: What do I need to do at the hospital during the study?

Your safety and visual health are our top priorities. We will provide meticulous, standardized eye examinations throughout the study:

Before the training begins, you will go through an 8- to 12-week "Refractive Stability Phase". During this time, we will perform cycloplegic refraction (dilation) and prescribe your glasses, checking your vision multiple times to ensure your baseline sight is completely stable.

During the study, you will only need to visit the clinic for follow-ups at Weeks 6 and 12 (the Delayed Group will also have visits at Weeks 18 and 24).

At these visits, our examiners (who do not know which group you are in to ensure objectivity) will measure your vision using standard ETDRS charts, evaluate your contrast sensitivity (using the computerized FrACT test), assess your stereoacuity (3D vision), and capture advanced 3D structural scans of your retina and choroid using Swept-Source OCT.

Q4: Is the training safe? What if my vision gets worse? The visual training is entirely physical and non-invasive, with an excellent safety record.

In very rare cases, some participants might experience mild, temporary eye strain, headaches, or slight discomfort when they first start training.

Double-Safety & Rescue Protocols: We have set strict "rescue criteria". If at any point during your observation or training, your vision drops significantly or if you experience persistent double vision, we will immediately initiate a professional assessment. If necessary, we will halt the training and provide standard clinical medical care.

調査の概要

状態

募集

条件

研究の種類

介入

入学 (推定)

80

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

      • Shanghai、中国
        • 募集
        • Shanghai Eye Disease Prevention and Treatment Center
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria

  1. Written informed consent; age 18-39 years inclusive at randomization.
  2. Diagnosis of amblyopia, with amblyopic-eye BCVA of approximately 20-70 ETDRS letters (approximately decimal BCVA 0.05-0.6).
  3. Amblyopia caused by anisometropia, strabismus, or both, meeting the following definitions:

    Anisometropic amblyopia: interocular spherical-equivalent difference ≥1.00 D or astigmatic difference ≥1.50 D in any meridian, with no manifest strabismus at distance or near.

    Strabismic amblyopia: strabismus at distance or near, or a history of strabismus surgery, without meeting the anisometropia criterion.

    Combined-mechanism amblyopia: meeting both the strabismus and anisometropia criteria.

  4. Completion of standardized optical correction and the 8-12-week stability period; absolute difference between week -4 and week 0 ETDRS scores <5 letters, with no continuing pretreatment improvement trend.
  5. Ability to use the study device for home training and accept electronic adherence monitoring.

Exclusion Criteria

  1. Eccentric fixation, clinically significant nystagmus, or inability to complete reliable ETDRS testing.
  2. Corneal, lenticular, retinal, macular, optic-nerve, or neurologic disease capable of explaining the visual-acuity reduction.
  3. Study-eye spherical equivalent <-8.00 D, or high refractive error judged by the investigator to compromise test reliability.
  4. Recent intraocular surgery or ocular trauma, or extraocular-muscle surgery considered likely to affect outcomes.
  5. Diplopia at baseline that interferes with safety evaluation, or an unacceptable training risk as judged by the investigator.
  6. Patching, penalization, other visual training, or treatment likely to affect amblyopia outcomes within the prespecified period before randomization.
  7. Inability to complete follow-up, understand the tasks, or participation in another clinical study likely to affect outcomes.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:Immediate-Training Group

Gabor-Based Perceptual Learning:

Home-based training will use the RevitalVision visual perceptual-learning software. Training should be conducted in a dark or standardized low-illumination environment, with a calibrated computer display as the primary light source and a viewing distance of 1.5 m. Training modes include single-image, clarity, lateral-masking, and image-shift tasks, with parameters adaptively adjusted according to performance.

他の:Delayed-Training Group
Delayed-Training Group: Gabor-Based Perceptual Learning Home-based training will be delayed by 12 weeks.

Gabor-Based Perceptual Learning:

Home-based training will use the RevitalVision visual perceptual-learning software. Training should be conducted in a dark or standardized low-illumination environment, with a calibrated computer display as the primary light source and a viewing distance of 1.5 m. Training modes include single-image, clarity, lateral-masking, and image-shift tasks, with parameters adaptively adjusted according to performance.

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Change in amblyopic-eye ETDRS letters
時間枠:Change from randomized baseline in amblyopic-eye ETDRS letters at week 12
Change from randomized baseline in amblyopic-eye ETDRS letters at week 12

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年5月25日

一次修了 (推定)

2026年10月1日

研究の完了 (推定)

2026年12月1日

試験登録日

最初に提出

2026年8月9日

QC基準を満たした最初の提出物

2026年8月9日

最初の投稿 (実際)

2026年8月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月13日

QC基準を満たした最後の更新が送信されました

2026年8月9日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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