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Huvitz biometer HBM-1’s precision and agreement study

Huvitz Biometer HBM-1’s precision and agreement study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009379
Enrollment
144
Registered
2024-04-26
Start date
2024-05-02
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

None listed

Interventions

None listed

Sponsors

Huvitz
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Normal eye (1) AGE: 19 – 85years, Gender: both (2) Those who is able to follow the instruction of the Medical staff. (3) Those who have signed in written consents. Cataract eye (1, 2, 3) including normal eye (1),(2),(3) (4) Those who has a cataract eye in nuclear opacity, nuclear color, cortical opacity or posterior subcapsular opacity with a LOCS III scale’s classification. Pseudophakic eye (1, 2, 3) including normal eye’s inclusion criteria(1),(2),(3) (5) Those who has a eye with a IOL.

Exclusion criteria

Exclusion criteria: (1) Pregnant women (2) Those who has a insufficient eye opening, or incorrect eyelash alignment that causes to poor signal in the reflection from the cornea. (3) Those who cannot fix the gaze, which can affect image acquisition and measured values. (4) Those who wear a hard contact lens within last 2 weeks or soft contact lens within last 2hours. (5) Those who has a active infection in ocular. (6) Those who has a ophthalmic surgery eye, including laser treatment/surgery, refractive index correction surgery and other surgery for cornea disease or retina disease. (7) Those who has a eye that investigator deems to be confounding or inappropriate for participation.

Design outcomes

Primary

MeasureTime frame
Precision between HBM-1 and IOL Master 700;Safety between HBM-1 and IOL Master 700

Secondary

MeasureTime frame
Agreement between HBM-1 and IOL Master 700

Countries

Korea, Republic of

Contacts

Public ContactJae Hoon Jeong

Chung-Ang University Gwangmyeong Hospital

j2h23@hanmail.net+82-2-2610-6742

Outcome results

None listed

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