This is a prospective, Open-label, comparative clinical study to asses two brilliant blue G dyes as staining agent in Vitro Retinal Surgery.
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
86
Kartal Dr. Lütfi Kirdar Şehir Hastanesi
Istanbul, Turkey (Türkiye)
Staining Ability of ILM
Staining of ILM is assed after dye injection with choosing Excellent/Good/ Needs to Improve by surgeon
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: 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)
Time frame: Pre-Op, 6 Month
Change from Baseline to 6 Month in Vascular evaluation
Vascular evaluation is assed with FFA(Fundus Fluorescein Angiography)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 6 Months
Visualization of Stained Membrane
Visualization of Membrane is assed before and after dye injection with choosing poor/good options by surgeon
Time frame: 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.
Time frame: 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.
Time frame: Pre-op, 1 Month, 3 Month and 6 Month