Infracyanine Green vs Brilliant Blue G in Inverted Flap Surgery for Medium to Large Macular Holes: A Swept Source OCT Analysis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Thickness maps of the 1 mm central foveal thickness; second 3-mm grid including parafoveal macular area; second and the third 6-mm grid including parafoveal and perifoveal ganglion cells and inner plexiform layer; peripapillary nerve fiber layer.
研究概览
简要总结
This study will compare by swept-source optical coherence tomography (SS-OCT) the retinal morphology after inverted internal limiting membrane (I-ILM) flap vitreoretinal surgery for medium-to-large macular holes using infracyanine green (IFCG) vs brilliant blue G (BBG) dyeing. It is a single-center prospective, randomized study. One group of patients will undergo I-ILM vitrectomy with IFCG staining, the other vitrectomy with BBG staining. Postoperative twelve-month corrected distance visual acuity, macular hole closure rate, and SS-OCT parameters will be compared and statistically analyzed. The aim of the study is to verify if these parameters can be negatively affected by toxicity related to the use of one of the two dyes.
详细描述
The purpose of this study is to compare by swept-source optical coherence tomography (SS-OCT) the retinal morphology after inverted internal limiting membrane flap (I-ILM) surgery for medium-to-large macular holes (FTMHs) using infracyanine green (IFCG) vs brilliant blue G (BBG). This prospective randomized study include 40 eyes with ≥ 400 µ idiopathic FTMH undergoing IFCG or BBG-stained I-ILM technique. Just before surgery, randomization is performed using the sealed-envelope technique, based on the patients' surgical chart number. The random allocation sequence is generated by the trial statistician pulling 41 standard-sized pieces of paper out of a hat. Twenty pieces of paper are marked with the Letter I, for IFCG, and 21 with the Letter B, for BBG. The trial statistician then sequentially puts each piece of paper into 41 sealed opaque envelopes. These envelopes are numbered 1 to 41 and given to the surgeons. Patients are numbered randomly from 1 to 41 based on a surgical chart number related to the baseline testing session and intervention period. Clinical data collection and measurement of outcome variables are performed by personnel masked to the randomization process and not been directly involved in the patients' surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Authors involved in clinical data collection and measurement of outcome variables are not been directly involved in the patients' surgery and are masked to the randomization process
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phakic or pseudophakic patients affected with medium to large idiopathic full thickness macular hole (FTMH), with a minimum preoperative diameter of 400 µ
排除标准
- •Patients with chorioretinal diseases except FTMH, myopia > 5 D, history of glaucoma, previous trauma or ocular surgery other than cataract extraction, or conditions affecting visual acuity except cataract.
研究组 & 干预措施
IFCG = Infracyanine Green stained eyes
After removal of core and posterior cortical vitreous and hyaloid stained with 0.2 ml triamcinolone acetonide 40 mg/mL, on the basis of the previous randomization the ILM is stained with 0.2 ml of low-concentration (0.5 mg/mL, 0.05%) IFCG injected over the macular area with the infusion line closed.
干预措施: Inverted inner limiting membrane flap technique for large full thickness macular holes (Device)
BBG = Brilliant Peel stained eyes
After removal of core and posterior cortical vitreous and hyaloid stained with 0.2 ml triamcinolone acetonide 40 mg/mL, on the basis of the previous randomization the ILM is stained with 0.2 mL BBG at a concentration of 0.25 mg/mL (0.025%) injected over the macular area with the infusion line closed.
干预措施: Inverted inner limiting membrane flap technique for large full thickness macular holes (Device)
结局指标
主要结局
Thickness maps of the 1 mm central foveal thickness; second 3-mm grid including parafoveal macular area; second and the third 6-mm grid including parafoveal and perifoveal ganglion cells and inner plexiform layer; peripapillary nerve fiber layer.
时间窗: twelve months
Measured in micrometers by auto-segmentation software (Topcon Advanced Boundary Software - TABSTM)
Postoperative macular hole closure rate and morphology
时间窗: twelve months
Evaluated by swept-source OCT (Topcon DRI OCT Triton Series)
Postoperative sizes of ellipsoid zone (EZ) and external limiting membrane (ELM) defects
时间窗: twelve months
Measured in micrometers by three-dimensional (3D) volumetric scan with swept-source OCT (Topcon DRI OCT Triton Series)
Postoperative mean corrected distance visual acuity
时间窗: twelve months
measured in logMAR notation using Early Treatment of Diabetic Retinopathy Study charts (CC-100XP LCD System for ETDRS Chart display)
次要结局
未报告次要终点
研究者
Salvatore Cillino
Head of the Ophthalmology Section of the Department of Biomedicine, Neurosciences and Advanced Diagnostic
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo