Development of Brilliant Blue G (BBG) as a new surgical dye for internal limiting membrane (ILM) staining in vitrectomy.

Phase 3

Completed

• Conditions: macular hole, epiretinal membrane, macular hole retinal detachment cased by high myopia , proliferative vitreoretinopathy, preproliferative diabetic retinopathy, diabetic macular edema, macular edema caused by occlusion of retinal vein.

• Registration Number: JPRN-jRCT1091220148
• Lead Sponsor: Kyushu University

Brief Summary

A0001 was effective and safe for visualization of the ILM during vitrectomy, and there was an improvement in ease of operation.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-18
• Study Completion: 2014-08-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the degree of visualization by independent data monitoring committee

Secondary Outcome Measures

Name	Time	Method
Evaluate the degree of visualization by operator