Skip to content

Myopic and Glaucomatous optic neuropathy changes using swept source OCT

Myopic and Glaucomatous optic neuropathy changes using swept source OCT - Myopia study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000024047
Enrollment
220
Registered
2016-09-23
Start date
2017-03-18
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

Glaucoma

Interventions

None listed

Sponsors

Topcon Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Normal persons: 1.Refractive error a)between +1 diopter sphere to -2 diopter sphere, b)between -2 diopter sphere to -5 diopter sphere, c)worse than -5 diopter sphere, all category are up to -2 diopter cylinder 2.Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3.Both eyes must be free from eye disease and possibility of disease Glaucoma patients: 1.Refractive error a)between +1 diopter sphere to -2 diopter sphere, b)between -2 diopter sphere to -5 diopter sphere, c)worse than -5 diopter sphere, all category are up to -2 diopter cylinder 2.Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3.Subjects presenting at the site with glaucoma 4.HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as Anderson and Patella criteria. This criteria includes: Abnormal GHT, PSD < 5%, or 3 points <=5% with one point <=1% in the upper or lower hemifield in the pattern deviation plot. 5.MD should be better than -12.0 dB 6.IOP should be under control and less than 21 mmHg on the day of imaging

Exclusion criteria

Exclusion criteria: Normal persons: 1.Family history of glaucoma 2.Subjects unable to tolerate ophthalmic imaging 3.Subject with ocular media not sufficiently clear to obtain acceptable OCT images 4.HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD < 1%, unless due to an enlarged blind spot. 5.HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses > 20% or false positives > 15% 6.Presence of any ocular pathology or suggestive pathologic observation 7.Previous cataract surgery or refractive surgery, Pseudophakic or aphakic 8.Narrow angle with Shaffer grade 2 or less 9.History of diabetes, leukemia, dementia or multiple sclerosis (disease that produces defect of retinal nerve) 10.History of whole body dosing of steroid or/and anticancer agent 11.Subjects with hypertension/hypotension Glaucoma patients: 1.Subjects unable to tolerate ophthalmic imaging 2.Subject with ocular media not sufficiently clear to obtain acceptable OCT images 3.HFA visual field (24-2 Sita Standard, white on white) result unreliable, defined as fixation losses > 20% or false positives > 15% 4.Presence of any ocular pathology other than glaucoma, or suggestive pathologic observation 5.Previous ocular surgery or laser treatment 6.History of diabetes, leukemia, dementia or multiple sclerosis (disease that produces defect of retinal nerve) 7.History of whole body dosing of steroid or/and anticancer agent 8.Subjects with hypertension/hypotension 9.Narrow angle with Shaffer grade 2 or less 10.Pseudophakic or aphakic

Design outcomes

Primary

MeasureTime frame
Thickness differences between groups. Statistical significance will be defined at the 0.05 level. A multivariate ANOVA. Correlations between the thickness values and patient characteristics including: age, refractive error, axial length, IOP, central corneal thickness, and visual field MD and PSD values.

Countries

Japan,Asia(except Japan),North America

Contacts

Public ContactTsutomu Kikawa

Topcon Corporation R&D Depertment, R&D Division

tkikawa@topcon.com03-3558-2512

Outcome results

None listed

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