Evaluation of Effect and Safety of 'RELUMINO-S'

Single-center, single arm, prospective, pivotal study to evaluate the effect and safety of Human tissue and organ substitute ‘RELUMINO-S’ for those with vision defect among low vision who cannot correct with glasses, contact lenses and surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006460

Enrollment

Registered

2021-08-18

Start date

2020-08-29

Completion date

Unknown

Last updated

2021-08-30

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

Conditions

None listed

Interventions

Others(Low vision aid) : After training session of smartphone based low vision aid, patients use low vision aid device at home for 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who are 19 years old or older 2. Patients with low vision who are thought not to be able to correct with glasses, contact lenses and surgery 3. Patients with best-corrected visual acuity between 0.48 LogMAR and 1.3 LogMAR in the better eye 4. Vision has been stable for at least for 3 months before the screening

Exclusion criteria

Exclusion criteria: 1. Patients who experienced intravitreal injection (ex. Anti-VEGF) or laser therapy within 6 months before the first screening 2. Patients who have disabilities other than low vision 3. Patients with orbital malformation or dermatological disease, unable to wear device 4. Alcohol abuse, drug abuse, mental illness, or significant systemic disease 5. Illiteracy who cannot read Korean

Design outcomes

Primary

Measure	Time frame
near, intermediate, distance visual acuity	—

Secondary

Measure	Time frame
reading performance test(accuracy, speed), schirmer test, tear film break up test, fluorescein corneal staining	—

Countries

Korea, Republic of

Contacts

Public ContactNam Ju Moon

Chung-Ang Univerisity Hospital

njmoon@cau.ac.kr+82-2-6299-1666

Outcome results