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A prospective, multicenter, self-paired clinical trial evaluating the safety and effectiveness of a strabismus detector for strabismus measurement

A prospective, multicenter, self-paired clinical trial evaluating the safety and effectiveness of a strabismus detector for strabismus measurement

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118066
Enrollment
Unknown
Registered
2026-02-02
Start date
2026-02-09
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Strabismus

Interventions

Gold Standard:A single measurement of the study participants was performed by a clinically experienced strabismus ophthalmologist, and the results were used as the reference standard.
Index test:Prism Combined with Alternate Cover Test : A single measurement is conducted on the study participant by a researcher using the trial medical device

Sponsors

Shijiazhuang People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Aged >=6 years, with no gender restrictions; (2) Meet one of the following criteria: a. Suspected of having concomitant strabismus (horizontal position) in both eyes, requiring strabismus measurement; b. Volunteers with emmetropic eyes in both eyes; (3) Able to understand the purpose of the trial, voluntarily participate, and have the informed consent form signed by the research participant or the research participant himself/herself and their legal guardian or their legal guardian.

Exclusion criteria

Exclusion criteria: (1) Patients with high myopia (equivalent spherical power +10D) in either eye. (2) Patients with other ophthalmic diseases, such as nystagmus, amblyopia, ptosis, severe eyelid dysplasia, atrophic eyeball, severe refractive media opacity, and severe corneal leukoma, who were deemed ineligible for enrollment by the researchers. (3) Those with cognitive impairment, mental illness, or intellectual issues, who, according to the researcher's judgment, are unable to cooperate with the examination. (4) Individuals with no fixation ability in either eye. (5) Subjects who have undergone relevant visual training (such as accommodative function training, vergence function training, and fusion function training) within the previous month will be selected. (6) Women who are pregnant or breastfeeding. (7) Subjects who participated in other intervention clinical trials within one month before screening and did not reach the trial endpoint. (8)Those who researchers consider unsuitable for participating in this trial.

Design outcomes

Primary

MeasureTime frame
Binocular strabismus degree (33cm);Binocular strabismus degree (6m);

Countries

China

Contacts

Public ContactWang Hui

Shijiazhuang People's Hospital

38551773@qq.com+86 136 7122 9245

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026