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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03946267

Recruitment Status : Completed

First Posted : May 10, 2019

Last Update Posted : July 15, 2020

Sponsor:

Information provided by (Responsible Party):

Salvatore Cillino, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Macular Holes	Device: Inverted inner limiting membrane flap technique for large full thickness macular holes	Not Applicable

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.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	43 participants
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)
Masking Description:	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
Primary Purpose:	Treatment
Official Title:	Infracyanine Green vs Brilliant Blue G in Inverted Flap Surgery for Medium to Large Macular Holes: A Swept Source OCT Analysis.
Actual Study Start Date :	January 9, 2018
Actual Primary Completion Date :	July 31, 2018
Actual Study Completion Date :	August 23, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: C.I. Acid Blue 90

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.
Experimental: 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.	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.

Arm

Intervention/treatment

Experimental: 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.

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.

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures :

Postoperative macular hole closure rate and morphology [ Time Frame: twelve months ]
Evaluated by swept-source OCT (Topcon DRI OCT Triton Series)
Postoperative mean corrected distance visual acuity [ Time Frame: twelve months ]
measured in logMAR notation using Early Treatment of Diabetic Retinopathy Study charts (CC-100XP LCD System for ETDRS Chart display)
Postoperative sizes of ellipsoid zone (EZ) and external limiting membrane (ELM) defects [ Time Frame: twelve months ]
Measured in micrometers by three-dimensional (3D) volumetric scan with swept-source OCT (Topcon DRI OCT Triton Series)
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. [ Time Frame: twelve months ]
Measured in micrometers by auto-segmentation software (Topcon Advanced Boundary Software - TABSTM)

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	45 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946267

Locations

Layout table for location information

Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90127

Sponsors and Collaborators

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Investigators

Layout table for investigator information

Principal Investigator:	Salvatore Cillino, MD, PhD	AOUP Paolo Giaccone, Palermo

More Information

Publications:

Michalewska Z, Michalewski J, Adelman RA, Nawrocki J. Inverted internal limiting membrane flap technique for large macular holes. Ophthalmology. 2010 Oct;117(10):2018-25. doi: 10.1016/j.ophtha.2010.02.011. Epub 2010 Jun 11.

Haritoglou C, Tadayoni R, May CA, Gass CA, Freyer W, Priglinger SG, Kampik A. Short-term in vivo evaluation of novel vital dyes for intraocular surgery. Retina. 2006 Jul-Aug;26(6):673-8.

Schmid-Kubista KE, Lamar PD, Schenk A, Stolba U, Binder S. Comparison of macular function and visual fields after membrane blue or infracyanine green staining in vitreoretinal surgery. Graefes Arch Clin Exp Ophthalmol. 2010 Mar;248(3):381-8. doi: 10.1007/s00417-009-1213-4. Epub 2009 Oct 13.

Burk SE, Da Mata AP, Snyder ME, Rosa RH Jr, Foster RE. Indocyanine green-assisted peeling of the retinal internal limiting membrane. Ophthalmology. 2000 Nov;107(11):2010-4.

Iriyama A, Uchida S, Yanagi Y, Tamaki Y, Inoue Y, Matsuura K, Kadonosono K, Araie M. Effects of indocyanine green on retinal ganglion cells. Invest Ophthalmol Vis Sci. 2004 Mar;45(3):943-7.

Baba T, Hagiwara A, Sato E, Arai M, Oshitari T, Yamamoto S. Comparison of vitrectomy with brilliant blue G or indocyanine green on retinal microstructure and function of eyes with macular hole. Ophthalmology. 2012 Dec;119(12):2609-15. doi: 10.1016/j.ophtha.2012.06.048. Epub 2012 Aug 24.

Park JH, Lee SM, Park SW, Lee JE, Byon IS. Comparative analysis of large macular hole surgery using an internal limiting membrane insertion versus inverted flap technique. Br J Ophthalmol. 2019 Feb;103(2):245-250. doi: 10.1136/bjophthalmol-2017-311770. Epub 2018 Apr 2.

Layout table for additonal information

Responsible Party:	Salvatore Cillino, Head of the Ophthalmology Section of the Department of Biomedicine, Neurosciences and Advanced Diagnostic, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
ClinicalTrials.gov Identifier:	NCT03946267
Other Study ID Numbers:	11/2016
First Posted:	May 10, 2019 Key Record Dates
Last Update Posted:	July 15, 2020
Last Verified:	July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Salvatore Cillino, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo:


Large macular hole Inverted flap surgery Infracyanine green Brilliant blue G Swept source OCT

Additional relevant MeSH terms:

Layout table for MeSH terms

Retinal Perforations Retinal Diseases Eye Diseases

To Top