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Virtual Reality-based Perceptual Learning Therapy for Visually Impaired Population

2026년 9월 4일 업데이트: Centre for Eye and Vision Research

Virtual Reality-based Perceptual Learning Therapy for Visually Impaired Population: Study Protocol for a Randomized Clinical Trial

Visual impairments significantly impact individuals' activities of daily living (ADL) and quality of life (QoL). While perceptual learning (PL) has shown promise in vision rehabilitation, traditional PL usually involves a protracted training process, and its training effects may sometimes lack ecological validity. This study protocol outlines a two-arm, single-blind, randomized controlled trial to evaluate the efficacy of an innovative virtual reality (VR)-based PL therapy integrated with machine learning algorithms. Twenty participants with visual field deficits will be recruited and randomized in a 1:1 ratio into either the VR training group or a no-intervention control group. The intervention consists of six visits (1-7 days apart), each involving two training tasks (20 - 30 minutes per task). The VR training task is an Ecological Multiple Object Tracking task and a Dual task. Training stimuli are personalized to target each participant's transition zone (1~20 dB) based on the result of clinical visual field test. A Deep Reinforcement Learning (DRL) framework, specifically the Proximal Policy Optimization (PPO) algorithm, is utilized as an adaptive controller to dynamically modulate task difficulty and maintain participants in an optimal cognitive "flow state". The primary outcome is visual field area improvement (measured by Humphrey Field Analyzer). Secondary outcomes include pre- and post-intervention assessments of visual search, balance ability, fear of falling, ADL, and QoL. It is hypothesized that participants in the VR training group will obtain improvements in primary and secondary outcomes.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

20

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

      • Hong Kong, 홍콩
        • Units 901-903, 9/F, Building 17W, 17 Science Park West Avenue, Hong Kong Science Park, Pak Shek Kok, Shatin
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Humphrey visual field analyzer (HFA) visual field loss (mean deviation of ≤-6 dB)

Exclusion Criteria:

  • Comprehension disorder that does not allow understanding of tests or training (e.g., in severe aphasia)
  • Currently under other PL treatment

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Virtual Reality-based Perceptual Learning Training

Prior to the training session, participants' visual fields will be assessed using standard automated perimetry (e.g., Humphrey Field Analyzer, 30-2 or 24-2 grid). Based on the decibel (dB) sensitivity maps from the clinical results, each participant's visual field will be classified into three functional zones: the intact zone (normal sensitivity), the absolute blind zone (<0 dB), and the transition zone or "gray area" (1~20 dB; relative scotoma characterized by reduced but present sensitivity).

One training session will be 20 ~30 minutes for each task. Participants will be asked to complete a total of 6 training sessions. In each training session, the participant will be asked to complete two tasks (i.e., ecological multiple object tracking task and dual task) which will take approximately one hour. Training sessions will be spaced at intervals of 1~7 days.

간섭 없음: No-intervention Control

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Visual Area Improvement
기간: Within one week after the training ends
Primary outcome is the visual area measured using the HVF (24-2, SITA-standard), where sensitivity increased by 6 dB or more relative to baseline in the defective hemifield or whole field.
Within one week after the training ends

2차 결과 측정

결과 측정
측정값 설명
기간
Pre/post-intervention assessments of visual search
기간: Within one week after the training ends
Visual search: Perceptual processing efficiency will be assessed using a visual search task - spatial configuration search task (Wolfe et al., 2010). In this task, participants were instructed to fixate on the centre of the screen and to locate a target. Each trial began with a short tone, followed after 500 ms by a search display. Participants pressed a key to report whether the target was present (in 50% of trials) or absent, responding as quickly and accurately as possible. Feedback-indicating response correctness-appeared for 500 ms after each trial. Trials were separated by a 1000-ms inter-trial interval. Set size was systematically varied across two conditions-6 items (1 target + 5 distractors) and 18 items (1 target + 17 distractors)-to quantify search efficiency. For each participant, reaction time (RT) was regressed on set size, and the resulting slope served as the primary index of perceptual processing efficiency: shallower slopes indicate higher efficiency.
Within one week after the training ends
Pre/post-intervention assessments of balance ability
기간: Within one week after the training ends
Balance: The Bertec Balance Advantage™ system is used to assess participants' balance before and after training. During the test, participants are asked to stand under different challenging conditions. Balance-challenging conditions include (1) standing on a firm or foam surface (Fi/Fo); (2) standing surface with backward or forward translation (BT/FT); and (3) standing with their eyes close (EC). Outcome measures, including root mean square sway of the center of pressure in the anterior - posterior and medial -lateral directions (mm/s), total sway path length (mm), and maximum CoP displacement in the AP and ML directions (mm)
Within one week after the training ends
Pre/post-intervention assessments of fear of fall
기간: Within one week after the training ends
Fear of fall: The English & Chinese version of the Falls Efficacy Scale-International (FES-I) is a validated and reliable questionnaire used to assess fear of falling in everyday life. The FES-I total score ranges from 16 to 64. Higher scores indicate greater concern about falling and therefore a worse outcome.
Within one week after the training ends
Pre/post-intervention assessments of quality of life (a)
기간: Within one week after the training ends
The National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25), English and Chinese versions. The NEI VFQ-25 scores range from 0 to 100. Higher scores indicate better visual functioning and better vision-related quality of life and therefore represent a better outcome.
Within one week after the training ends
Pre/post-intervention assessments of quality of life (b)
기간: Within one week after the training ends
The Chinese version of the Low Vision Quality of Life Questionnaire (CLVQOL) is used to assess vision-related quality of life. The CLVQOL contains 25 items, each scored from 0 to 5, resulting in a theoretical total score ranging from 0 to 125. Higher scores indicate fewer vision-related difficulties and better vision-related quality of life and therefore represent a better outcome.
Within one week after the training ends

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 1일

기본 완료 (추정된)

2028년 10월 1일

연구 완료 (추정된)

2029년 1월 1일

연구 등록 날짜

최초 제출

2026년 8월 31일

QC 기준을 충족하는 최초 제출

2026년 9월 4일

처음 게시됨 (실제)

2026년 9월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 4일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • CEVR-PL-20260831

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 공유 기간

After the publication of the study results, for an indefinite period.

IPD 공유 액세스 기준

Upon reasonable request and with approval from the study's principal investigator.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .