Assessment of Binocular Vision Function With Neos™ (ROCKET) (ROCKET)

Clinical Performance of Neos™ for the Assessment of Binocular Vision Function: A Prospective Multicentre Cross-Sectional Study (ROCKET)

ROCKET evaluates the clinical performance of an investigational version of neos™, a non-invasive device that uses a virtual-reality headset and eye tracking to assess binocular vision-how the two eyes work together.

The study compares neos™ results with standard clinical examinations for three functions: sensory fusion, the ability to combine images from both eyes into a single image; stereopsis, the perception of depth from differences between the images seen by each eye; and suppression, reduced awareness of visual input from one eye during binocular viewing.

Approximately 184 patients aged 3 years and older who require a clinical binocular vision assessment will participate at ophthalmology centres in Switzerland. Each participant will undergo standard clinical testing and a neos™ examination during a single study visit. During the neos™ examination, visual stimuli are presented through the headset while the device records eye movements and pupil responses.

The main objective is to determine how accurately neos™ identifies the presence or absence of sensory fusion, stereopsis and central suppression compared with the clinical reference assessments. Additional analyses will compare fusion-related measurements, characterize stereopsis and suppression, and explore relationships between neos™ measurements and clinical findings.

Study Overview

• Status: Not yet recruiting
• Conditions: Binocular Vision Dysfunction
• Intervention / Treatment: Diagnostic test: Manual binocularity assessment

Detailed Description

The investigation uses a prospective, multicentre, cross-sectional, paired within-participant design. Each participant receives both assessments on the same day and serves as their own comparator, reducing the influence of differences between participants. There is no random allocation. Although the investigation is not formally blinded, clinicians performing the reference examination do not have access to automated neos™ results when determining the clinical classifications. Investigational results do not influence treatment decisions.

The investigation comprises two sequential phases. An initial tuning phase includes 10 selectively recruited participants: five with preserved fusion and stereopsis without suppression, and five with absent fusion and stereopsis and suppression present. These data are used to refine algorithm parameters and thresholds. The algorithm configuration is then locked and remains unchanged throughout the validation phase. Tuning-phase participants are excluded from all analysis sets.

During validation, eligible patients are recruited consecutively when study personnel and procedures are available. Recruitment includes patients with and without suspected or confirmed binocular dysfunction, reflecting the population undergoing clinical binocularity assessment. Approximately 174 participants are expected to enter validation to obtain around 157 evaluable participants. The final enrolment depends on the observed distribution of clinical reference classifications and the proportion of evaluable examinations.

The investigational configuration uses neos™ software version 4.0.0-rocket, incorporating additional binocular visual stimuli and algorithms. The examination typically takes less than 15 minutes. It includes gaze holding and ocular alignment, stimuli for assessing suppression, fusion and stereopsis, pupillary function, saccades, smooth pursuit and visual-field assessment.

The clinical reference examination is performed by an appropriately trained healthcare professional using established methods selected according to clinical findings and participant cooperation. These may include prism bar testing, Bagolini striated lenses, Worth 4-Dot testing and standardized stereotests. Not every test is required for every participant; suitable reference information must be obtained for each primary classification. When specified test results are unavailable, unusable or omitted for clinical reasons, the protocol allows the orthoptist's clinical diagnosis to determine the reference classification.

Prespecified rules define the reference outcomes. Sensory fusion is present when binocular single perception is demonstrated using Bagolini striated lenses or Worth 4-Dot testing. Stereopsis is present when stereoscopic disparity of 600 arcseconds or finer is detected. Central suppression is classified using a hierarchical rule: it is absent when stereopsis or sensory fusion is present. When both are absent, suppression is present if clinical testing demonstrates failure to perceive input from one eye; otherwise, it is classified as absent.

Diagnostic performance is assessed separately for each primary endpoint using a two-by-two comparison of neos™ and clinical reference classifications. Sensitivity and specificity are reported with two-sided 95% exact Clopper-Pearson confidence intervals. An endpoint meets its prespecified success criterion when the lower confidence bounds for both sensitivity and specificity exceed 65%. There is no composite success criterion across the three endpoints and no multiplicity adjustment. Agreement on the affected eye is summarized descriptively among participants classified as suppression-present by both methods.

Validation recruitment ends when all prespecified reference-class requirements are met: at least 41 evaluable participants without sensory fusion, 73 with stereopsis, 73 without stereopsis and 22 with suppression. An operational review at approximately 80 evaluable participants, or earlier if indicated, examines reference-class prevalence to update enrolment projections. It does not examine agreement between neos™ and the reference assessment. No formal interim efficacy or futility analysis is planned.

Secondary analyses compare neos™ fusion break-off angles with clinical prism-bar measurements using Bland-Altman analysis. Agreement in stereopsis severity categories is assessed using weighted Cohen's kappa. Suppression-related outputs and other eye-movement, pupil and visual-field measurements are characterized descriptively, with exploratory comparisons across clinically defined groups. No formal performance goals apply to these secondary analyses.

Primary analyses include participants with conclusive results from both methods for the endpoint concerned. Missing classifications are not imputed. Participants may contribute to one endpoint analysis even if another endpoint is not evaluable. Evaluability rates and reasons for missing or inconclusive results are reported. Safety assessments include validation-phase participants who begin the neos™ examination. No routine follow-up visit is planned; ongoing adverse events are followed as clinically appropriate until resolution or stabilization.

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pia Massatsch, PhD; Phone Number: 800-555-5555; Email: clinical@machinemd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled to undergo, or having undergone, a clinical binocularity assessment at the investigational site on the same day.
• Age ≥3 years at the time of consent.
• Ability to understand and comply with the examination, in the investigator's opinion.
• Written informed consent provided by the participant and/or legal representative.

Exclusion Criteria:

• Best-corrected visual acuity worse than 0.2 decimal (0.7 logMAR) in either eye.
• Refractive error beyond the range that can be corrected by the system, including lens inserts and the use of contact lenses.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: neos™ Assessment and Clinical Reference Examination; All participants undergo the investigational neos™ assessment and a standard clinical binocular vision examination during the same visit. The clinical examination serves as the reference standard for comparing classifications of sensory fusion, stereopsis and central suppression, and for assessing agreement in fusion-related measurements.

Diagnostic test: Manual binocularity assessment; Standard clinical binocular vision examination performed by a trained healthcare professional. Assessments may include prism bar testing, Bagolini striated lenses, Worth 4-Dot testing and standardized stereotests, selected according to clinical findings and participant cooperation. Suitable reference information is obtained for each primary outcome. The examination lasts approximately 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity of neos™ for Detecting Sensory Fusion	Sensitivity and specificity of the neos™ sensory fusion classification (present/absent) compared with the clinical reference classification. Reference sensory fusion is present when binocular single perception is demonstrated using Bagolini striated lenses or Worth 4-Dot testing. Performance is calculated from paired classifications and reported with two-sided 95% exact Clopper-Pearson confidence intervals.	During the single study visit (approximately 60 minutes).
Sensitivity and Specificity of neos™ for Detecting Stereopsis	Sensitivity and specificity of the neos™ stereopsis classification (present/absent) compared with standard clinical stereotesting. For both methods, stereopsis is classified as present when stereoscopic disparity of 600 arcseconds or finer is detected. Performance is calculated from paired classifications and reported with two-sided 95% exact Clopper-Pearson confidence intervals.	During the single study visit (approximately 60 minutes).
Sensitivity and Specificity of neos™ for Detecting Central Suppression	Sensitivity and specificity of the neos™ central (foveal) suppression classification (present/absent) compared with the clinical reference classification. The reference uses a prespecified hierarchical rule: suppression is absent when stereopsis or sensory fusion is present. When both are absent, suppression is present if clinical testing demonstrates failure to perceive input from one eye; otherwise, it is absent. Performance is reported with two-sided 95% exact Clopper-Pearson confidence intervals.	During the single study visit (approximately 60 minutes).

Collaborators and Investigators

• Sponsor: machineMD AG
• Collaborators: Kantonsspital Aarau; Hôpital ophtalmique Jules-Gonin (HOJG)
• Investigators: Principal Investigator: Muriel Dysli, MD PhD, Kantonsspital Aarau

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: October 30, 2026
• First Submitted That Met QC Criteria: October 30, 2026
• First Posted (Actual): November 5, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: October 30, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Virtual reality; Stereopsis; Binocular vision; Eye tracking; Stereoacuity; Fusional vergence; Sensory fusion; Central suppression; neos
• Other Study ID Numbers: CI-002; 2026-D0075 (Other Identifier: Swissethics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No