Trial Outcomes & Findings for Evaluation of a Program to Enhance Ophthalmic Compliance in Children and Adolescents With Special Needs (NCT NCT06717282)
NCT ID: NCT06717282
Last Updated: 2026-03-13
Results Overview
The Visual Function Battery for Children with Special Needs (VFB-CSN) is a standardized measure assessing multiple domains of visual function in children and adolescents with special needs. The VFB-CSN contains eight categories, namely visual reflex, ocular muscle balance, visual acuity, oculomotor, visual field, contrast sensitivity, colour/form vision, and visual attention. The total scores of the VFB-CSN ranges from 0 to 60. Higher scores indicate better visual function.
COMPLETED
NA
20 participants
Pre-intervention and post-intervention (within 6 months)
2026-03-13
Participant Flow
Participants were recruited between December 15, 2024 and January 21, 2026 from a special needs ophthalmology clinic, including children and adolescents who attended the clinic for ophthalmic evaluation.
Participant milestones
| Measure |
Experimental: Intervention to Improve Ophthalmic Compliance
Key Features of the Intervention: 1. Contextual Adaptation: Participants practice ophthalmic examination procedures in a simulated clinical environment to familiarize themselves with real-world conditions. 2. Behavioral Strategies: Positive reinforcement, such as rewards (snacks, toys, or videos), is used to encourage participation and cooperation during sessions. 3. Cognitive Support: Animated materials and interactive exercises are employed to teach the concepts required for visual tests, with take-home tasks for generalization. 4. Individualized Goals: Individualized training plans and objectives are established collaboratively with caregivers based on participants' cognitive and behavioral profiles. Duration and Frequency: Six sessions, each lasting one hour, are conducted biweekly, with flexibility based on caregiver availability.
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline age data were available for all enrolled participants (N = 20).
Baseline characteristics by cohort
| Measure |
Experimental : Intervention to Improve Ophthalmic Compliance
n=20 Participants
Behavioral: Using contextual, behavioral, and cognitive-based stragegies to develop training programs Key Features of the Intervention: 1. Contextual Adaptation: Participants practice ophthalmic examination procedures in a simulated clinical environment to familiarize themselves with real-world conditions. 2. Behavioral Strategies: Positive reinforcement, such as rewards (snacks, toys, or videos), is used to encourage participation and cooperation during sessions. 3. Cognitive Support: Animated materials and interactive exercises are employed to teach the concepts required for visual tests, with take-home tasks for generalization. 4. Individualized Goals: Individualized training plans and objectives are established collaboratively with caregivers based on participants' cognitive and behavioral profiles. Duration and Frequency: Six sessions, each lasting one hour, are conducted biweekly, with flexibility based on caregiver availability.
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Age, Continuous
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6.82 Years
STANDARD_DEVIATION 2.64 • n=20 Participants • Baseline age data were available for all enrolled participants (N = 20).
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Sex: Female, Male
Female
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8 Participants
n=20 Participants • Sex was recorded for all enrolled participants (N = 20).
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Sex: Female, Male
Male
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12 Participants
n=20 Participants • Sex was recorded for all enrolled participants (N = 20).
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PRIMARY outcome
Timeframe: Pre-intervention and post-intervention (within 6 months)Population: Fourteen participants (N = 14) were included in the outcome analysis due to incomplete pre- and/or post-intervention data in 6 participants.
The Visual Function Battery for Children with Special Needs (VFB-CSN) is a standardized measure assessing multiple domains of visual function in children and adolescents with special needs. The VFB-CSN contains eight categories, namely visual reflex, ocular muscle balance, visual acuity, oculomotor, visual field, contrast sensitivity, colour/form vision, and visual attention. The total scores of the VFB-CSN ranges from 0 to 60. Higher scores indicate better visual function.
Outcome measures
| Measure |
Experimental: Intervention to Improve Ophthalmic Compliance
n=14 Participants
Key Features of the Intervention: 1. Contextual Adaptation: Participants practice ophthalmic examination procedures in a simulated clinical environment to familiarize themselves with real-world conditions. 2. Behavioral Strategies: Positive reinforcement, such as rewards (snacks, toys, or videos), is used to encourage participation and cooperation during sessions. 3. Cognitive Support: Animated materials and interactive exercises are employed to teach the concepts required for visual tests, with take-home tasks for generalization. 4. Individualized Goals: Individualized training plans and objectives are established collaboratively with caregivers based on participants' cognitive and behavioral profiles. Duration and Frequency: Six sessions, each lasting one hour, are conducted biweekly, with flexibility based on caregiver availability.
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Visual Function Battery for Children With Special Needs (VFB-CSN)
Baseline (pre-intervention)
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45.00 score
Standard Deviation 5.08
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Visual Function Battery for Children With Special Needs (VFB-CSN)
Post-intervention
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48.21 score
Standard Deviation 5.47
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SECONDARY outcome
Timeframe: Baseline (pre-intervention) and post-intervention (within 6 months).Population: Fourteen participants (N =14) were included in the outcome analysis due to incomplete pre- and/or post-intervention data in 10 participants.
The Ophthalmic Visit Adaptation Questionnaire was developed to assess adaptive behaviors and degrees of cooperation during ophthalmic examination in both special ophthanmic clinics and general ophthalmic clinics for children/adolescents with special needs. The questionnaire consists of 18 items, and each item is rated a 5-point Likert scale raning from 1 to 5, where higher scores indicate better adaptation and cooperation. The total score is calculated by summing the 18 item scores. Therefore, total scores range from 18 to 90 (scores on a scale).
Outcome measures
| Measure |
Experimental: Intervention to Improve Ophthalmic Compliance
n=14 Participants
Key Features of the Intervention: 1. Contextual Adaptation: Participants practice ophthalmic examination procedures in a simulated clinical environment to familiarize themselves with real-world conditions. 2. Behavioral Strategies: Positive reinforcement, such as rewards (snacks, toys, or videos), is used to encourage participation and cooperation during sessions. 3. Cognitive Support: Animated materials and interactive exercises are employed to teach the concepts required for visual tests, with take-home tasks for generalization. 4. Individualized Goals: Individualized training plans and objectives are established collaboratively with caregivers based on participants' cognitive and behavioral profiles. Duration and Frequency: Six sessions, each lasting one hour, are conducted biweekly, with flexibility based on caregiver availability.
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Ophthalmic Visit Adaptation Questionnaire
Baseline (pre-intervention)
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70.80 score
Standard Deviation 17.05
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Ophthalmic Visit Adaptation Questionnaire
Post-intervention
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78.50 score
Standard Deviation 20.17
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Adverse Events
Experimental: Intervention to Improve Ophthalmic Compliance
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Li-Ting Tsai, PhD (Central Contact Person)
Department of Occupational Therapy, College of Medicine, National Taiwan University Taipei, , Taiwan
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place