NCT04490876

Brief 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 ).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

5 days

First QC Date

July 25, 2020

Last Update Submit

July 28, 2020

Conditions

Proliferative Vitreoretinopathy

Keywords

Retinal DetachmentProliferative VitreoretinopathyInternal Limiting MembraneILM peelingBrilliant Blue G

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Mean Best Corrected Visual Acuity

    mean follow-up: 14.1 months

  • Spectral Domain OPTICAL COHERENCE TOMOGRAPHY (SD-OCT) IMAGING of the MACULA

    mean follow-up: 14.1 months

Study Arms (1)

Retinal Detachment with PVR

Proliferative vitreoretinopathy (PVR), a major complication of rhegmatogenous retinal detachment (RRD), is an abnormal process whereby proliferative, contractile cellular membranes form in the vitreous and on both sides of the retina, resulting in tractional retinal detachment with fixed retinal folds. Patients with RD complicated by PVR will be included, and the proposed intervention will be performed.

Procedure: 3D Pars Plana Vitrectomy associated with Extensive Brilliant Blue G-Assisted ILM Peeling Method

Interventions

3D Pars Plana Vitrectomy associated with Extensive Brilliant Blue G-Assisted ILM Peeling MethodPROCEDURE

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.

Retinal Detachment with PVR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Private retina clinic.

You may qualify if:

  • 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 .

You may not qualify if:

  • patients younger than 18 years age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Oftalmologico Dr Charles

Buenos Aires, Buenos Aires F.D., 1116, Argentina

Location

Related Publications (7)

  • 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.

    PMID: 29621507RESULT

  • 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. 2010 Jun;30(6):881-6. doi: 10.1097/IAE.0b013e3181c96952.

    PMID: 20182404RESULT

  • 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. doi: 10.1007/s00417-002-0601-9. Epub 2003 Feb 20.

    PMID: 12644944RESULT

  • Aras C, Arici C, Akar S, Muftuoglu 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;247(5):619-23. doi: 10.1007/s00417-008-1025-y. Epub 2008 Dec 24.

    PMID: 19107502RESULT

  • 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. doi: 10.1097/01.iae.0000236469.71443.aa.

    PMID: 16829804RESULT

  • 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):1816-1819. doi: 10.4103/ijo.IJO_59_18.

    PMID: 30451186RESULT

  • 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/s12886-019-1238-3.

    PMID: 31744475RESULT

MeSH Terms

Conditions

Vitreoretinopathy, ProliferativeRetinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor. Ophthalmologist Board Certificate. Fellowship in Vitreoretinal Diseases.

Study Record Dates

First Submitted

July 25, 2020

First Posted

July 29, 2020

Study Start

July 20, 2020

Primary Completion

July 25, 2020

Study Completion

July 25, 2020

Last Updated

July 30, 2020

Record last verified: 2020-07

Locations

AR(1)