Skip to content

A Study on Healthy Eye Reference Database of Koreans using Spectral Domain OCT.(Prospective, Single Institution, Public, Intervention, Single Group)

A Study on Healthy Eye Reference Database of Koreans using Spectral Domain OCT.(Prospective, Single Institution, Public, Intervention, Single Group)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003743
Enrollment
200
Registered
2019-04-11
Start date
2018-03-07
Completion date
Unknown
Last updated
2019-04-23

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

Conditions

None listed

Interventions

Medical Device : according to the pre-defined screenning test, measure the healthy eye 3times.

Sponsors

Huvitz
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age range between more than 20 ~ less than 70 years old. 2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. No ocular medication (except artificial tears/moistening drops) necessary 4. Eyes with spherical power <= ±4.0D, cylindrical power <= ±3.0D 5. Corrected distance visual acuity - = 1.0 [20/20] for subjects up to 60 years; - = 0.8 [20/25] for subjects from 61 to 70 years; 6. Intraocular pressure <= 21 mmHg 7. Normal anterior segments, i.e. no clinically-relevant abnormalities -. Eyes with no closed iridocorneal angle structure 8. Ocular fundus: normal appearance, i.e. no clinically-relevant abnormalities (examination with undilated pupils) 9. Eyes without prior intraocular surgery (except cataract surgery) without clinically-relevant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve. 10. Eyes without a history of corneal refractive surgery.

Exclusion criteria

Exclusion criteria: 1. Amblyopia 2. Relevant opacities of the central refractive media (cornea, lens, vitreous body) 3.Drugs indicating severe general diseases (anti-diabetic pharmaceuticals and anti-hypertensive medication are allowed for subjects older than 70 years) 4. Eyes having experience wearing hard contact(RGB) lenses within 2 weeks from the screening date 5. Pregnant or lactating women 6. One who can influence the study results by ethically or else, accordingly considered to be ineligible

Design outcomes

Primary

MeasureTime frame
Pearson correlation coefficient between age and thickness, RNFL thickness with segmentation.

Secondary

MeasureTime frame
O’clock hour segment thickness of RNFL;Macular thickness;Optic nerve head parameter area or ratio

Countries

Korea, Republic of

Contacts

Public ContactJEONG HOON

Konyang University Hospital

j2h23@hanmail.net+82-42-600-9250

Outcome results

None listed

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