- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07257341
Pilot Study of Normative Range of Field of Binocular Single Vision in Adults in Singapore (NORVIBAS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The assessment and monitoring of the field of binocular single vision is a crucial aspect of ophthalmological care, particularly in the management of oculoplastics and strabismus. Currently, clinicians worldwide, including those in Singapore, rely on the normal boundary of the field of binocular single vision established by Doctor Robert M. Feibel & Gill Roper-Hall in 1974 as the gold-standard parameter for clinical assessment. However, this long-standing standard raises several significant concerns regarding its applicability to our current population.
The original study by Feibel & Roper-Hall was conducted in St Louis, Missouri, United States of America, with participants who were likely of Caucasian descent. This demographic composition presents a potential limitation when applying these standards to Asian populations, particularly in Singapore, where ethnic and genetic factors may influence ocular characteristics. Furthermore, the study's methodology involved only "several" normal individuals, suggesting a sample size of more than two but fewer than ten participants. A sample size of this limited scope significantly increases the likelihood of Type II errors, potentially compromising the statistical power and reliability of the established normative values.
The temporal gap of over five decades since the original study adds another layer of concern. Population characteristics, environmental factors, and lifestyle patterns have undergone substantial changes during this period, potentially affecting ocular health parameters. Additionally, advances in measurement techniques and an understanding of ocular physiology suggest the need for updated normative data that reflect current population characteristics and incorporate modern assessment methodologies.
Given these limitations, there is a pressing need to establish population-specific normative data for the field of binocular single vision in Singapore's adult population. This would not only provide more relevant reference values for clinical assessment but also potentially improve the accuracy of diagnosis and monitoring of various ocular conditions in our local context.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Zheng Kuang Noel Soh, BSc
- Phone Number: +65 6357 3693
- Email: zheng.kuang.soh@nhghealth.com.sg
Study Locations
-
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Singapore
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Singapore, Singapore, Singapore, 308433
- Recruiting
- Tan Tock Seng Hospital
-
Contact:
- Zheng Kuang Noel Soh, BSc
- Phone Number: +65 6357 3693
- Email: zheng.kuang.soh@nhghealth.com.sg
-
Principal Investigator:
- Daniel Chin, MBBS
-
Sub-Investigator:
- Yan Tong Koh, MBBS
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Sub-Investigator:
- Sebastian Yue, MSc
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Sub-Investigator:
- Jackson Chng, BSc
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Sub-Investigator:
- Azizah Binte Hajamohideen, BSc
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Sub-Investigator:
- Zheng Kuang Noel Soh, BSc
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age: 21 to 59 years old
- Gender: Males or females
- Ethnicity: Asian descent.
Language comprehension: Able to understand verbal spoken instructions in:
• British/American English
- Mandarin Chinese
- Bahasa Melayu
- Protocol compliance: Ability to comply with the study protocol, as determined by the investigator's judgment
- Consent capacity: Must be able to understand and provide informed consent, with signed informed consent form required before any study assessments
Exclusion Criteria:
- Communication barrier: Unable to understand verbal spoken instructions
Medical history:
- Any facial trauma
- Any ocular trauma
- Any head trauma
- Any history of ocular disease
- Any history of ocular surgery
- Systemic condition(s)
Near visual acuity:
o Right eye & Left eye monocularly, binocularly unaided near vision: worse than N6 at 40cm from participant's nose
Ocular alignment:
o Prism cover test at near (30cm) of equal or greater than 10 prism diopters at these positions of gaze:
- Primary gaze
- Right gaze
- Left gaze
- Up gaze
- Down gaze
Extraocular movement:
o Extraocular movement of over-action or under-action of equal or greater than 0.5 in any of the nine cardinal positions of gaze
Confrontational Visual field:
o Abnormal monocular visual field on confrontational visual field test
- Hess chart test o Abnormal or asymmetry in pattern of extraocular muscle action in Hess chart test
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Field of Binocular Single Vision in Asian population
Time Frame: up to 20 minutes during 1 study visit.
|
Establish comprehensive normative range of field of binocular single vision (BSV) specifically for healthy adults in Singapore's population aged 21-59, creating locally relevant reference standards that reflect ethnic, genetic, and contemporary population. BSV is the ability to use both eyes simultaneously and coordinate the slightly different images from each eye into a single, unified, three-dimensional mental percept. The "field of binocular single vision" is the specific area within the overall visual field where this fusion and single vision can be maintained. To measure the field of BSV using Goldmann perimetry, a moving light stimulus is presented while the patient uses both eyes. The test maps the area where the patient can maintain fusion (single vision). The boundary where fusion breaks (and diplopia starts) is plotted across different directions to define the BSV field. |
up to 20 minutes during 1 study visit.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of current field of binocular single vision gold standard between Caucasian population vs Asian population
Time Frame: Up to 20 minutes during 1 study visit.
|
Conduct rigorous statistical comparison between newly established Singapore normative values and existing Feibel & Roper-Hall (1974) standards to quantify differences and determine clinical significance. Current benchmarks are based on a 1974 U.S. study by Feibel & Roper-Hall that involved fewer than ten Caucasian subjects and no Asian representation. Consequently, clinicians may over- or under-diagnose ocular deviation and fusion deficits in Asian patients. The study validates a modern methodology using the Takagi MT-325UD Projection Perimeter to map BSV fields under standardized conditions. |
Up to 20 minutes during 1 study visit.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Chin, MBBS, Tan Tock Seng Hospital
- Study Director: Sebastian Yue, MSc, Tan Tock Seng Hospital
Publications and helpful links
General Publications
- Feibel RM, Roper-Hall G. Evaluation of the field of binocular single vision in incomitant strabismus. Am J Ophthalmol. 1974 Nov;78(5):800-5. doi: 10.1016/0002-9394(74)90303-1. No abstract available.
- Kakizaki H, Umezawa N, Takahashi Y, Selva D. Binocular single vision field. Ophthalmology. 2009 Feb;116(2):364. doi: 10.1016/j.ophtha.2008.08.046. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025-1293
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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