NCT07257341

Brief Summary

The assessment and monitoring of the field of binocular single vision remains a crucial aspect of ophthalmological care, yet current clinical practice relies on normative standards established by Feibel \& Roper-Hall in 1974 that present significant limitations for contemporary application. The original study, conducted with a demographically homogeneous Caucasian population in St Louis using only "several" normal individuals, raises concerns regarding its applicability to Asian populations, particularly in Singapore, where ethnic and genetic factors may influence ocular characteristics. The limited sample size significantly increases the likelihood of Type II errors, whilst the temporal gap of over five decades introduces additional concerns regarding population changes, environmental factors, and advances in measurement techniques that have not been incorporated into current normative data. Given these substantial limitations in demographic representation, statistical power, and temporal relevance, there exists a pressing need to establish population-specific normative data for the field of binocular single vision in Singapore's adult population, which would provide more clinically relevant reference values and potentially improve diagnostic accuracy for ocular conditions in the local context.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
5mo left

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Oct 2025Oct 2026

Study Start

First participant enrolled

October 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2026

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

November 20, 2025

Last Update Submit

January 7, 2026

Conditions

Keywords

Binocular field of vision

Outcome Measures

Primary Outcomes (1)

  • Field of Binocular Single Vision in Asian population

    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 Outcomes (1)

  • Comparison of current field of binocular single vision gold standard between Caucasian population vs Asian population

    Up to 20 minutes during 1 study visit.

Interventions

The intervention involves a single field of binocular single vision assessment using the Takagi MT-325UD Projection Perimeter. Participants undergo binocular testing where they fixate and follow a single round light stimulus as it moves throughout the perimeter bowl. When participants perceive two distinct light stimuli (indicating loss of binocular single vision), they press a buzzer. The orthoptist records these responses and plots the boundaries on a standardised recording sheet to map the participant's field of binocular single vision. This intervention addresses significant limitations of the current gold standard established by Feibel \& Roper-Hall (1974). The original study was conducted with "several" normal individuals (likely fewer than 10 participants) of Caucasian descent in St Louis, Missouri, creating potential issues with statistical power and population applicability. Our study uses a larger, more robust sample size of 32 participants specifically from Singapore's Asian

Eligibility Criteria

Age21 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy Individuals

You may qualify if:

  • 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

You may not qualify if:

  • \- 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore, 308433, Singapore

RECRUITING

Related Publications (2)

  • 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 Officials

  • Daniel Chin, MBBS

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR
  • Sebastian Yue, MSc

    Tan Tock Seng Hospital

    STUDY DIRECTOR

Central Study Contacts

Zheng Kuang Noel Soh, BSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 2, 2025

Study Start

October 15, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

October 14, 2026

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Participant data cannot be shared due to local governing laws and institutional regulations.

Locations