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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Staining Ability of ILM
研究概览
简要总结
This is a prospective, Open-label, comparative clinical study to asses two brilliant blue G dyes as staining agent in Vitro Retinal Surgery.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Staining Ability of ILM
时间窗: Intra-Operatively
Staining of ILM is assed after dye injection with choosing Excellent/Good/ Needs to Improve by surgeon
Change from Baseline to 1 Month, 3 Months and 6 Months in CMT (Central Macular Thickness)
时间窗: Pre-Op, 1 Month, 3 Month and 6 Month
CMT (Central Macular Thickness) in micron meters is accessed with ocular coherence tomography
Change from Baseline to 1 Month, 3 Months and 6 Months in TMV ( Total Macular Volume)
时间窗: Pre-Op, 1 Month, 3 Month and 6 Month
TMV ( Total Macular Volume) in cubic millimeter is accessed with ocular coherence tomography
Change from Baseline to 1 Month, 3 Months and 6 Months in SFCT (sub foveal choroidal thickness)
时间窗: Pre-Op, 1 Month, 3 Month and 6 Month
SFCT (sub foveal choroidal thickness) in cubic meter is accessed with ocular coherence tomography
Change from Baseline to 6 Month in Foveal perfusion characteristics
时间窗: Pre-Op, 6 Month
Foveal perfusion characteristics are assed with FFA(Fundus Fluorescein Angiography)
Change from Baseline to 1 Month, 3 Months and 6 Months in Intra-retinal cuff pathology segmentation
时间窗: Pre-Op, 1 Month, 3 Month and 6 Month
Intra-retinal cuff pathology segmentation in micron meter is accessed with ocular coherence tomography
Change from Baseline to 1 Month, 3 Months and 6 Months in RNFL Thickness (Retinal Nerve Fiber Layer)
时间窗: Pre-Op, 1 Month, 3 Month and 6 Month
RNFL Thickness (Retinal Nerve Fiber Layer) in micron meter is accessed with ocular coherence tomography
Change from Baseline to 1 Month, 3 Months and 6 Months in Hole diameter
时间窗: Pre-Op, 1 Month, 3 Month and 6 Month
Hole diameter in micron meter is accessed with ocular coherence tomography
Change from Baseline to 1 Month, 3 Months and 6 Months in Optic Disc situation
时间窗: Pre-Op, 1 Month, 3 Month and 6 Month
Optic Disc situation is accessed with ocular coherence tomography
Change from Baseline to 6 Month in Vascular evaluation
时间窗: Pre-Op, 6 Month
Vascular evaluation is assed with FFA(Fundus Fluorescein Angiography)
Change from Baseline to 6 Month in Fundus auto fluorescence (FAF)
时间窗: Pre-Op, 6 Month
Fundus auto fluorescence (FAF) are assed with FFA(Fundus Fluorescein Angiography)
Multifocal ERG
时间窗: Pre-op, 1 Month, 3 Month and 6 Month
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.
Overview of Adverse Events
时间窗: Through study completion, an average of 6 Months
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.
次要结局
- Visualization of Stained Membrane(Intra-Operatively)
- Visual Field Analyses(Pre-op, 1 Month, 3 Month and 6 Month)
- Best Corrected Visual Acuity(Pre-op, 1 Month, 3 Month and 6 Month)
研究者
Aysu Karatay Arsan
Assoc. Prof. MD
Dr. Lutfi Kirdar Kartal Training and Research Hospital