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Data collection in Non-diseased Eyes with Long Axial Length and Development of Software using RS-3000

Data collection in Non-diseased Eyes with Long Axial Length and Development of Software using RS-3000 - Data collection in Non-diseased Eyes with Long Axial Length and Development of Software using RS-3000

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004377
Enrollment
288
Registered
2010-11-01
Start date
2010-11-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Healthy individuals

Interventions

Sponsors

Kyoto University Graduate School of Medicine
Lead Sponsor
Nagoya University Graduate School of Medicine, Kanazawa University Graduate School of Medical Science, Tokyo Medical and Dental University, National University Health System
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Male and female aged 20 and over 2) Subjects who follow the instructions by Principal/Clinical investigator or clinical staff at Clinical center, and can visit on a scheduled examination date 3) Subjects who agree to take the qualifying examination and OCT data acquisition 4) Subjects who sign an informed consent form to participate in the clinical study 5) Axial length is 26mm or more but less than 30mm.

Exclusion criteria

Exclusion criteria: 1) Exclusion criteria regarding systemic disease a) a) Diabetes mellitus b) b) Uncontrollable hypertension c) c) Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision d) d) Cardiac, hepatic, renal and hematologic diseases, and other moderate to severe complications e) e) During systemic administration of steroid f) f) History of anticancer agent etc. g) g) Optically-stimulated epileptic seizure h) h) Dementia i) i)Life-threatening and Debilitating disease j) j)Subjects who currently (within the past 14 days) take any medication which stimulates photosensitivity (e.g. Visudyne, Ciprofroxacin, Bactrim or doxycycline), and subjects who administer concomitant hydroxychloroquine and chloroquine k) k) Other serious systemic diseases 2) Exclusion criteria regarding ocular disease a) a) History of keratorefractive surgery b) b) History of retinal photocoagulation c) History of intraocular surgeries except cataract surgery that had been operated before 6 months or more of qualifying examination day d) Diabetic retinopathy or any other fundus diseases e) Congenital abnormalities of fundus including optic disc. f) Any corneal disorders that would prevent the applanation tonometry g) Serious external ocular diseases, intraocular or eyelid inflammation or external ocular injuries h) Pathological or degenerative myopia 3) Exclusion criteria regarding qualifying examination. 4) Exclusion criteria regarding OCT imaging Subjects who can or could have any difficulty associated with OCT data acquisition

Design outcomes

Primary

MeasureTime frame
To demonstrate the three-dimensional distribution of macular thickness in Non-diseased Eyes with Long Axial Length by spectral domain optical coherence tomography (SD-OCT), and to evaluate the association between macular thickness and sex, age, axial length, and race.

Countries

Japan,Asia(except Japan)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026