Clinical trial to evaluate the efficacy and safety of SRT(Selective Retina Therapy) in patients with Diabetic Macular Edema

A single-center, single arm, open label clinical trial to evaluate the efficacy and safety of SRT(Selective Retina Therapy) in patients with Diabetic Macular Edema

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0001415

Enrollment

Registered

2015-03-16

Start date

2013-12-20

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Medical Device : Selective Retina Therapy - 527nm(Wavelength), 1.7us(Pulse duration)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adults older than 19 years 2) Patients with type II diabetes without a history of ophthalmological treatment 3) Patients who were diagnosed with clinically significant Diabetic Macular Edema based on the criteria of ETDRS (Early Treatment Diabetic Retinopathy Study) 4) Patients with decreased visual acuity 5) Patients with focal edema or patchy diffuse edema 6) Patients who agreed to participate in this study and signed or whose legally acceptable representative signed the Informed Consent Form

Exclusion criteria

Exclusion criteria: 1) Patients with ischemic Diabetic Macular Edema that showed rupture in the foveal avascular zone due to the obstruction of more than 30% of the capillary vessels in the central circle, as observed using fluorescein fundus angiography 2) Patients with rubeosis iridis 3) Patients who cannot be treated with laser due to their cataract or vitreous opacity 4) Patients with a history of intra-ocular surgery 5) Patients with a history of focal steroid treatment, injection of anti-VEGF agents, or focal or grid laser exposure of their macular area within 4 months (including Pan retinal photocoagulation) 6) Patients with glaucoma or other retinal vascular diseases 7) Patients with confirmed allergy to fluorescein, indocyanine green, or iodine 8) Patients with clinically significant diseases such as renal failure based on the investigator’s judgment 9) Patients who are pregnant, breastfeeding, or planning to be pregnant 10) Patients with other conditions that would make it difficult for them to participate in this study, based on the investigator’s judgment

Design outcomes

Primary

Measure	Time frame
Best Corrected Visual Acuity	—

Secondary

Measure	Time frame
Retinal Thickness;Exudate;Visual field sensitivity;Adverse events, slit lamp biomicroscopy results, vital signs, and laboratory test results for safety	—

Countries

Korea, Republic of

Contacts

Public ContactYounggun Park

The Catholic University of Korea, Yeouido St. Mary's Hospital

cuteyg2000@gmail.com

Outcome results