Safety and Efficacy Evaluation of Two Different Brilliant Blue G Dyes as Staining Agent in Vitreo Retinal Surgery.

Republic of Turkey Ministry of Health

Status: Completed

Conditions: Macular Holes; Epiretinal Membrane

Study type: Observational

Funder types: Other

Identifiers

NCT05086588

BTOPL-BBG-001

Details and patient eligibility

About

This is a prospective, Open-label, comparative clinical study to asses two brilliant blue G dyes as staining agent in Vitro Retinal Surgery.

Full description

The study was designed as prospective, open label, comparative observational study. The patients over 18 years old and undergone Macular Surgery, Internal Limiting membrane removal surgery or vitreomacular traction using the two brilliant blue G dyes as staining agent in Vitro Retinal Surgery were planned to enroll the study. Two blue G dyes (Bio Blue 90 plus and ILM Blue) was randomly assigned at the subject's initial intraoperative visit, according to a computer-generated randomization schedule. During the pars plana vitrectomy, Bio Blue 90 Plus or ILM Blue dyes were injected into eye to stain ILM. Injected Dye was removed from the eye at the end of study before injecting long term tamponade. A total of 5 visits were conducted during the study. Out of them pre-operative visit was done on 1 visit, Surgery/Intraoperative visit and thereafter there were three follow-up visits. The follow- up visits were performed at 1 month, 3 months and 6 Months after the completion of Surgery. Clinical evaluation will be done recording and using staining Ability of ILM (Intra-Operatively), Visualization of Stained Membrane (Intra-Operatively),OCT parameters: (Pre-Op & Post-Op Follow-Up), FFA parameters: (Pre-Op & Post-Op Follow-Up),Fundus auto fluorescence (FAF), Multifocal ERG (Pre-Op & Post-Op Follow-Up) and Visual Field analyses (Pre-Op & Post-Op Follow-Up).

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 18 years of age
• Patient undergone Macular Surgery, Epiretinal membrane removal surgery or vitreomacular traction using the study device
• Patient who can attend all the regular follow-up examinations as per the routine schedule.
• Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read signed and dated by the patient.

Exclusion criteria

• Standard exclusion criteria for Macular Surgery like trauma history, previous macular surgery, rhegmatogenous retinal detachment together with macular hole, myopia higher than 10 diopter (D), macular hole for more than 2 years and previous retinal vessel disease.
• Participated in any study during the use of the study device.

Trial design

86 participants in 2 patient groups

Bio Blue 90 Plus

Description:

Patients who were underwent Macular Surgery using Bio Blue 90 Plus (Brilliant Blue G Dye; 0.25 g /l concentration in 0.5 ml BD Glass Syringe; Biotech Vision Care Pvt. Ltd., Ahmedabad, India.)

ILM Blue

Description:

Patients who were underwent Macular Surgery using ILM Blue (Brilliant Blue G Dye; 0.25 g /l concentration in 0.5 ml BD Glass Syringe; D.O.R.C. Dutch Ophthalmic Research Center (International) B.V., Zuidland, The Netherlands)