Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Proliferative Vitreoretinopathy

Proliferative Vitreoretinopathy Clinical Trial

— ILM  

Official title:

Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Retinal Detachment With Proliferative Vitreoretinopathy Using 3D Visualization System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04490876
• Other study ID #: 3701001
• Status: Completed
• Start date: July 20, 2020
• Est. completion date: July 25, 2020

Study information

• Verified date: July 2020
• Source: Centro Oftalmológico Dr Charles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to report outcomes of pars plana vitrectomy (PPV) in retinal detachment (RD) accompanied with proliferative vitreoretinopathy (PVR) after extensive Brilliant Blue G-Assisted internal limiting membrane (ILM) peeling using a 3D visualization system.

This is retrospective consecutive case series of 14 eyes treated with PPV for RD repair. The patients were follow for 7 to 47 months (mean follow-up: 14.1 months ).

Description:

This is the retrospective study of 14 consecutive patients suffering from retinal detachment with proliferative vitreoretinopathy who underwent primary PPV at the Department of Retina of Centro Oftalmologico Dr Charles, Buenos Aires-Argentina between January 1, 2016 and August 1, 2020 . This study followed the tenets of the Declaration of Helsinki and it was approved by the approved by the research ethics committee (www.comitedeeticaceic.com.ar). Written informed consent was taken from all subjects. All cases were performed by a single experienced vitreoretinal surgeon (MCH)

The treatment chosen in the study was pars plana vitrectomy with Brilliant Blue G (BBG) staining using the Ngenuity 3D Visualization System (Alcon). We spread 0.05% w/v BBG solution (OCUBLUE PLUS, Aurolab), approximately 0.3-0.5 ml, on the retinal surface and peeled off the ILM from the posterior pole up to the periphery, thus ensuring the total removal of the overlying epiretinal membranes responsible for recurrent detachment. Frequent restaining with BBG helped revealing new edges and perfluorocarbon liquid was used in others to stabilize the retina (Figure1). ).. All patients underwent vitreoretinal surgery due to RD (rhegmatogenous, tractional or combined rhegmatogenous and tractional). Exclusion criteria from the study was the time of follow-up less than 6 months.

Average age at the time of the presence of RD was 56 ± 8.7 years (range 23-77 years). Pre- and postoperative data were collected. Descriptive statistical analysis included gender, age at the presentation, laterality, etiology, duration of presenting symptoms, presences of ocular comorbidities, macular status (attached or non-attached), presence of PVR (preretinal, subretinal and intraretinal) initial and final best-corrected visual acuity (BCVA), number of procedures, type of endotamponade during PPV, final lens status, duration of the follow-up, anatomical success and complications. Indications for PPV were as follows: presence of advanced PVR and/or total RD and/or multiple breaks, giant retinal tears. PVR was graded according to the Retina Society Terminology Classification and anatomical location (references). Visual acuity was measured by Snellen charts. The anatomical success was defined as persistent retinal reattachment at the last follow-up visit (in absence of silicone oil tamponade).

Statistical computations were performed using STATA 16 data analysis and statistical software (StataCorp LLC, College Station, Texas, USA)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 25, 2020
• Est. primary completion date: July 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients older than 18 years age suffering from retinal detachment with proliferative vitreoretinopathy who underwent primary PPV at the Department of Retina of Centro Oftalmologico Dr Charles, Buenos Aires-Argentina between January 1, 2016 and August 1, 2020 .

Exclusion Criteria:

• patients younger than 18 years age

Related Conditions & MeSH terms

• Proliferative Vitreoretinopathy
• Retinal Detachment

Intervention

Procedure:
• 3D Pars Plana Vitrectomy associated with Extensive Brilliant Blue G-Assisted ILM Peeling Method
After the injection of Brilliant Blue-G (BBG) into the vitreous cavity, the epiretinal membrane (ERM) with cellular proliferation on the surface of the retina did not stain clearly, while the internal limiting membranes did stain clearly. We peeled off the internal limiting membrane (ILM) underlying the ERM using the ILM forceps for the macular area and the serrated forceps for the remaining ILM beyond the vascular arcades (Grieshaber, Alcon Laboratories, Inc., Fort Worth, Texas (Figure1) and enhanced membrane viewing with filters on the Ngenuity system. Restaining with BBG was needed and perfluorocarbon liquid PFCL was injected with a coaxial Dual Bore cannula (MedOne) to flatten the retina.

Locations

Country	Name	City	State
Argentina	Centro Oftalmologico Dr Charles	Buenos Aires	Capital Federal

Sponsors (1)

Lead Sponsor	Collaborator
Centro Oftalmológico Dr Charles

Country where clinical trial is conducted

Argentina, 

References & Publications (7)

Aras C, Arici C, Akar S, Müftüoglu G, Yolar M, Arvas S, Baserer T, Koyluoglu N. Peeling of internal limiting membrane during vitrectomy for complicated retinal detachment prevents epimacular membrane formation. Graefes Arch Clin Exp Ophthalmol. 2009 May;2 — View Citation

Enaida H, Hisatomi T, Hata Y, Ueno A, Goto Y, Yamada T, Kubota T, Ishibashi T. Brilliant blue G selectively stains the internal limiting membrane/brilliant blue G-assisted membrane peeling. Retina. 2006 Jul-Aug;26(6):631-6. — View Citation

Foveau P, Leroy B, Berrod JP, Conart JB. Internal Limiting Membrane Peeling in Macula-off Retinal Detachment Complicated by Grade B Proliferative Vitreoretinopathy. Am J Ophthalmol. 2018 Jul;191:1-6. doi: 10.1016/j.ajo.2018.03.037. Epub 2018 Apr 3. — View Citation

Kumar A, Hasan N, Kakkar P, Mutha V, Karthikeya R, Sundar D, Ravani R. Comparison of clinical outcomes between "heads-up" 3D viewing system and conventional microscope in macular hole surgeries: A pilot study. Indian J Ophthalmol. 2018 Dec;66(12):1816-181 — View Citation

Lai CT, Kung WH, Lin CJ, Chen HS, Bair H, Lin JM, Chen WL, Tien PT, Tsai YY. Outcome of primary rhegmatogenous retinal detachment using microincision vitrectomy and sutureless wide-angle viewing systems. BMC Ophthalmol. 2019 Nov 19;19(1):230. doi: 10.1186 — View Citation

Odrobina DC, Michalewska Z, Michalewski J, Nawrocki J. High-speed, high-resolution spectral optical coherence tomography in patients after vitrectomy with internal limiting membrane peeling for proliferative vitreoretinopathy retinal detachment. Retina. 2 — View Citation

Sakamoto H, Yamanaka I, Kubota T, Ishibashi T. Indocyanine green-assisted peeling of the epiretinal membrane in proliferative vitreoretinopathy. Graefes Arch Clin Exp Ophthalmol. 2003 Mar;241(3):204-7. Epub 2003 Feb 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistent retinal reattachment	The anatomical success was defined as persistent retinal reattachment at the last follow-up visit (in absence of silicone oil tamponade).	6 months after silicone oil removal
Secondary	Mean Best Corrected Visual Acuity	BCVA was recorded at each visit, reported in Snellen fraction and converted into logarithm of the minimal angle of resolution (logMAR) values for statistical analysis.	mean follow-up: 14.1 months
Secondary	Spectral Domain OPTICAL COHERENCE TOMOGRAPHY (SD-OCT) IMAGING of the MACULA	SD-OCT images were obtained with the Spectralis OCT with eye-tracking dual-beam technology (Heidelberg Engineering GmbH, Heidelberg, Germany) and reviewed with the Heidelberg Eye Explorer (version 1.8.6.0) using the HRA/Spectralis Viewing Module (version 5.8.3.0). All patients underwent the Sequential 12-line radial scans and were evaluated for the presence of intraretinal/subretinal fluid. Mean central foveal thickness was obtained with the automated ''thickness map'' function of the Heidelberg Eye Explorer.	mean follow-up: 14.1 months