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A prospective multicenter study of ripasudil effects for secondary glaucoma

A prospective multicenter study of ripasudil effects for secondary glaucoma - A prospective multicenter study of ripasudil effects for secondary glaucoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018378
Enrollment
250
Registered
2015-07-27
Start date
2015-10-30
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

Secondary glaucoma including exfoliation glauocma, uveitic glaucoma and steroid-induced glaucoma.

Interventions

0.4% ripasudil ophthalmic solution. twice daily. for 6 months.

Sponsors

Department of Ophthalmology, Faculty of Life Sciences, Kumamoto University.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Secondary glaucoma patients who need additional IOP reduction therapy will be recruited, when prior anti-glaucoma ophthalmic solution do not respond efficiently.

Exclusion criteria

Exclusion criteria: 1) Contraindicated for use in ripasudil. 2) Patients whose MD value in Humphrey visual field examination (program SITA-standard 24-2) is -12 dB or less. 3) Patient with poor best corrected visual acuity (less than 20/40). 4) Patient with severe refractive error (over +9.0 D or below -9.0 D). 5) Eye with over 3.0 D difference of spherical equivalent power compared to fellow eye. 6) Patients with the corneal disorder to inhibit accurate IOP measurement by Goldmann applanation tonometer. 7) Patients with poor mydriasis and whose optic disc is unobservable. 8) Eyes that had undergone intraocular surgery or intraocular laser therapy. However, the eyes that underwent cataract surgery after a lapse of 6 months could be included. 9) Eyes with a history of ocular trauma. 10) Patients with the retinal disorder which influences visual field. 11) Patients with the optic nerve disorder or intracranial disease which influences visual field. 12) Patients who is rejected as unsuitable case for this study by principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Comparison of intraocular pressure between at baseleine and at 6-month follow-up period.

Secondary

MeasureTime frame
1) Comparison of intraocular pressure (IOP) between at baseleine and at each follow-up period (1-, 2-, 3-, and 6-month). 2) Relationship between IOP reduction and inflammation severelity in uveitic glaucoma patients. 3) Detection of predictive factors for IOP reduction effects. 4) Frequency of adverse events.

Countries

Japan

Contacts

Public ContactKana Nakamoto

Institute for Clinical Effectiveness ROCK-S Study Office

rock@icekyoto.org075-778-5054

Outcome results

None listed

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