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

A Prospective, Open-label, Comparative Clinical Study to Evaluate the Safety and Efficacy of BIO-BLUE 90 PLUS With ILM-Blue® as Staining Agent in Vitreo Retinal Surgery.

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

Study Overview

• Status: Completed
• Conditions: Epiretinal Membrane; Macular Holes

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34865
    • Kartal Dr. Lutfi Kirdar sehir Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who were underwent Macular Surgery using study devices were included in the study

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Bio Blue 90 Plus; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Staining Ability of ILM	Staining of ILM is assed after dye injection with choosing Excellent/Good/ Needs to Improve by surgeon	Intra-Operatively
Change from Baseline to 1 Month, 3 Months and 6 Months in CMT (Central Macular Thickness)	CMT (Central Macular Thickness) in micron meters is accessed with ocular coherence tomography	Pre-Op, 1 Month, 3 Month and 6 Month
Change from Baseline to 1 Month, 3 Months and 6 Months in TMV ( Total Macular Volume)	TMV ( Total Macular Volume) in cubic millimeter is accessed with ocular coherence tomography	Pre-Op, 1 Month, 3 Month and 6 Month
Change from Baseline to 1 Month, 3 Months and 6 Months in SFCT (sub foveal choroidal thickness)	SFCT (sub foveal choroidal thickness) in cubic meter is accessed with ocular coherence tomography	Pre-Op, 1 Month, 3 Month and 6 Month
Change from Baseline to 1 Month, 3 Months and 6 Months in Intra-retinal cuff pathology segmentation	Intra-retinal cuff pathology segmentation in micron meter is accessed with ocular coherence tomography	Pre-Op, 1 Month, 3 Month and 6 Month
Change from Baseline to 1 Month, 3 Months and 6 Months in RNFL Thickness (Retinal Nerve Fiber Layer)	RNFL Thickness (Retinal Nerve Fiber Layer) in micron meter is accessed with ocular coherence tomography	Pre-Op, 1 Month, 3 Month and 6 Month
Change from Baseline to 1 Month, 3 Months and 6 Months in Hole diameter	Hole diameter in micron meter is accessed with ocular coherence tomography	Pre-Op, 1 Month, 3 Month and 6 Month
Change from Baseline to 1 Month, 3 Months and 6 Months in Optic Disc situation	Optic Disc situation is accessed with ocular coherence tomography	Pre-Op, 1 Month, 3 Month and 6 Month
Change from Baseline to 6 Month in Foveal perfusion characteristics	Foveal perfusion characteristics are assed with FFA(Fundus Fluorescein Angiography)	Pre-Op, 6 Month
Change from Baseline to 6 Month in Vascular evaluation	Vascular evaluation is assed with FFA(Fundus Fluorescein Angiography)	Pre-Op, 6 Month
Change from Baseline to 6 Month in Fundus auto fluorescence (FAF)	Fundus auto fluorescence (FAF) are assed with FFA(Fundus Fluorescein Angiography)	Pre-Op, 6 Month
Multifocal ERG	During multifocal ERG testing, the patient views a rapidly changing sequence on the monitor. The resulting electrical activity is recorded by an electrode, then amplified and analyzed. During stimulation the hexagons on the screen independently change every 13 milliseconds. They all follow the same pseudorandom sequence, with each hexagon starting at a slightly different position in this sequence. Using a cross-correlation technique, the software determines the retinal response from each of the 103 segments of the retina.	Pre-op, 1 Month, 3 Month and 6 Month
Overview of Adverse Events	An AE could be any unfavorable and unintended symptom, sign, disease or condition, or test abnormality whether or not considered related to the investigational product. A serious adverse event (SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAE): AEs that developed/worsened during the 'on treatment period' (from first dose of study device until the end of study period). Category "AE" included participant with both serious and non-serious AE.	Through study completion, an average of 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visualization of Stained Membrane	Visualization of Membrane is assed before and after dye injection with choosing poor/good options by surgeon	Intra-Operatively
Visual Field Analyses	A test that measures the extent and distribution of the field of vision. A visual field test is done via automated perimetry.	Pre-op, 1 Month, 3 Month and 6 Month
Best Corrected Visual Acuity	Monocular visual acuity for each eye is be assessed using ETDRS charts held at 4 M.	Pre-op, 1 Month, 3 Month and 6 Month

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Investigators: Principal Investigator: Aysu Karatay Arsan, MD, Kartal Dr. Lutfi Kirdar sehir Hastanesi

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 4, 2018
• Primary Completion (ACTUAL): June 12, 2020
• Study Completion (ACTUAL): June 12, 2020

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (ACTUAL): October 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Macular Hole; Brilliant Blue G Dye; ILM Pealing
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations; Epiretinal Membrane
• Other Study ID Numbers: BTOPL-BBG-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No