JPRN-jRCT1091220148CompletedPhase 3
Development of Brilliant Blue G (BBG) as a new surgical dye for internal limiting membrane (ILM) staining in vitrectomy. - A new vital surgical dye for vitrectomy.
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Kyushu University
- Enrollment
- 30
Study Overview
Brief Summary
A0001 was effective and safe for visualization of the ILM during vitrectomy, and there was an improvement in ease of operation.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1) Patients required for vitrectomy in one or both eyes
- •Primary diseases for vitrectomy are macular hole, epiretinal macular membrane, macular hole retinal detachment cased by high myopia , proliferativevitreoretinopathy, preproliferative diabetic retinopathy, diabetic macular edema, macular edema cased by occlusion of retinal vein, and stainig and peeling of internal limiting membrane in vitrectomy are necessary.
- •2) Age : >=20 years old at the time of obtaining informed consent
- •3) Male or female passed 2 years after menopause
- •4) Patients comply with the schedule instructed by PI or SI
- •5) Patients take part in this trial based on their own free will and give informed consent in written form.
Exclusion Criteria
- •1) Vitrectomized eye.
- •2) Has serious of digestive, circulatory, kidney, liver, or blood/coagulation complications
- •3) Had present and past uveitis or glaucoma
- •4) Has a history of drug hypersensitivity reactions for Triamcinolone acetonide, mydriatic, antibacterial eyedrops or local anesthetic.
- •5) Has a history of drug or alcohol abuse
- •6) Had taken this clinical trial
- •7) Will take part in in another clinical trial or clinical research during this clinical trial
- •8) Is deemed unsuitable for this trial by PI or SI
Investigators
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