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

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Status: Completed

Conditions: Macular Holes

Treatments: Device: Inverted inner limiting membrane flap technique for large full thickness macular holes

Study type: Interventional

Funder types: Other

Identifiers

NCT03946267

11/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Phakic or pseudophakic patients affected with medium to large idiopathic full thickness macular hole (FTMH), with a minimum preoperative diameter of 400 µ

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups

IFCG = Infracyanine Green stained eyes

Experimental group

Description:

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.

Treatment:

Device: Inverted inner limiting membrane flap technique for large full thickness macular holes

BBG = Brilliant Peel stained eyes

Experimental group

Description:

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.

Treatment:

Device: Inverted inner limiting membrane flap technique for large full thickness macular holes