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A clinical study comparing the accuracy and repeatability of measurement results between MYO 200 and similar ophthalmic optical biometers

A clinical study comparing the accuracy and repeatability of measurement results between MYO 200 and similar ophthalmic optical biometers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093282
Enrollment
Unknown
Registered
2024-12-02
Start date
2024-12-02
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

None

Interventions

MYO 200 trial group:Optical instrument: MYO 200
IOLMaster 500 control group:Optical instrument: IOLMaster 500
SW-9000 Plus control group:Optical instrument: Optical instrument: SW-9000 Plus

Sponsors

Fudan University Affiliated Eye, Ear, Nose and Throat Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Age 8-40 years, male or female 2. Equivalent spherical lens power between +5.00D and -15.00D 3. Astigmatism <= 6.00D 4. Consent to participate in the study and signed Informed consent form

Exclusion criteria

Exclusion criteria: 1. History of trauma or undergone ophthalmic surgery in the measured eye within 6 months prior to the study 2. History of focusing ability defects such as nystagmus and strabismus in the measurement eye, and cannot fix by fixation 3. Cornea of the measured eye is partially or completely covered due to palpebral fissure closure or stenosis, and cannot be measured 4. Previous macular edema, retinal detachment, corneal leukoplakia, thick cataract, posterior subcapsular opacity, or intravitreal hemorrhage and other diseases that affect the results of axial measurement; 5. With pseudophak, prosthetic eye or other ocular structural abnormalities installed in the measured eye; 6. Have recently worn orthokeratology lenses and other contact lenses 7. History of cycloplegic refractive state prior to examination 8. Inability to sit upright in front of the device, or inability to rest their head on their forehead or jaw rest, that due to unable to cooperate with the measurement process 9. Have a severe systemic disease assessed by investigators that is not suitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Axial length;Anterior corneal surface curvature;

Secondary

MeasureTime frame
Time is measured monoccularly;

Countries

China

Contacts

Public ContactChen Zhi

Fudan University Affiliated Eye, Ear, Nose and Throat Hospital

peter459@aliyun.com+86 137 6168 1740

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026