Prospective study of the safety after implantation of iSert Micro 255 Multicenter Study / Epidemiologic research

Prospective study of the safety after implantation of iSert Micro 255 Multicenter Study / Epidemiologic research - Prospective study of the safety after implantation of iSert Micro 255 Multicenter Study / Epidemiologic research

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000012723

Enrollment

9000

Registered

2014-01-06

Start date

2014-01-06

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

cataract

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patient in the age is from 40 to 90 at the time of consent acquisition (2) Patient who cooperate in postoperative follow-up (A patient who can visit a hospital at least postoperative 2nd month)

Exclusion criteria

Exclusion criteria: (1) Patient who already extracted his/her crystalline lens and has become an aphakic eye or a fake (artificial) crystalline lens eye (2) Patient who simultaneously undergoes other eye surgery or intravitreal injection of various medicines (3) Patient with following preexisting conditions *Patient with active uveitis *Patient with rubeosis iriditis *Patient with uncontrollable glaucoma *Patient with progressive diabetic retinopathy (4) Patient who is assessed as ineligible for this research by an research doctor (5) Patient who decline to cooperate with the research

Design outcomes

Primary

Measure	Time frame
Rate of postoperative endophthalmitis	—

Secondary

Measure	Time frame
Rate of postoperative adverse events	—

Countries

Japan

Contacts

Public ContactEiji Namba

HOYA CORPORATION Medical Division

eiji.namba@hoya.com03-5913-2347

Outcome results