Infracyanine Green vs Brilliant Blue G in Macular Hole Inverted Flap Surgery: A Swept Source OCT Analysis.
Condition: Macular Holes
MeSH terms: Retinal Perforations
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Inverted inner limiting membrane flap technique for large full thickness macular holes
Intervention type(s): Device
Intervention description(s): The ILM, stained with IFCG or BBG, is peeled off with ILM forceps, usually beginning near the inferotemporal vascular arcade, at least 2 disk diameters from the macular hole, in a circular manner. The peeling is extended up to the edges of the macular hole, the wide ILM flap obtained reduced by trimming with the vitreous cutter, and the annular remnant of ILM hinged to the hole's edge gently inverted upside down facing the RPE. Therefore, the hole is covered with usually more layers of inverted ILM. Attention is paid to avoid insertion and filling of the hole volume with ILM.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients assigned to undergo inverted flap surgery with infracyanine green or with brilliant blue G using the sealed-envelope randomization technique. The interventional study model consists of a randomized controlled trial study design.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Large macular hole; Inverted flap surgery; Infracyanine green; Brilliant blue G; Swept source OCT