NCT03946267

Infracyanine Green vs Brilliant Blue G in Macular Hole Inverted Flap Surgery: A Swept Source OCT Analysis.

Infracyanine Green vs Brilliant Blue G in Inverted Flap Surgery for Medium to Large Macular Holes: A Swept Source OCT Analysis.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo · Academic / Other
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Macular Holes

Interventions

Type	Name	Description
DEVICE	Inverted inner limiting membrane flap technique for large full thickness macular holes	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.

Timeline

• Start date: 2018-01-09
• Primary completion: 2018-07-31
• Completion: 2018-08-23
• First posted: 2019-05-10
• Last updated: 2020-07-15

Locations

1 site across 1 country: Italy