Proliferative VitreoretinopathyILMNCT04490876
Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Proliferative Vitreoretinopathy
An observational study of Proliferative Vitreoretinopathy, run by Centro Oftalmológico Dr Charles at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Vitreoretinopathy
- What is being tested?
- 3D Pars Plana Vitrectomy associated with Extensive Brilliant Blue G-Assisted ILM Peeling Method
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteArgentina
- Study dates
- 20 Jul 2020to 25 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Private retina clinic.
Who may be able to join
- 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 .
Who cannot join
- patients younger than 18 years age
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Centro Oftalmologico Dr Charles
Buenos Aires, Buenos Aires F.D., 1116
About this study
Official title: Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Retinal Detachment With Proliferative Vitreoretinopathy Using 3D Visualization System
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 ).
Read the detailed 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)
- Conditions
- Proliferative Vitreoretinopathy
- Being tested
- 3D Pars Plana Vitrectomy associated with Extensive Brilliant Blue G-Assisted ILM Peeling Method
- Keywords
- Retinal Detachment, Proliferative Vitreoretinopathy, Internal Limiting Membrane, ILM peeling, Brilliant Blue G
- Medical subject headings
- Vitreoretinopathy, Proliferative, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Pars Plana Vitrectomy associated with Extensive Brilliant Blue G-Assisted ILM Peeling MethodProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 3D Pars Plana Vitrectomy associated with Extensive Brilliant Blue G-Assisted ILM Peeling Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent retinal reattachment
The anatomical success was defined as persistent retinal reattachment at the last follow-up visit (in absence of silicone oil tamponade).
Measured: 6 months after silicone oil removal
Secondary outcomes (2)
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.
Measured: mean follow-up: 14.1 months
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.
Measured: mean follow-up: 14.1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start20 Jul 2020
- Primary completion25 Jul 2020
- Study completion25 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Proliferative VitreoretinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Oftalmológico Dr Charles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anibal Andres Francone, Centro Oftalmológico Dr Charles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490876
- Sponsor's protocol ID
- 3701001
- Acronym
- ILM
- Status last verified
- Jul 2020
- First submitted
- 25 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29621507Odrobina 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.
PubMed 20182404Sakamoto 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.
PubMed 12644944Aras 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.
PubMed 19107502Enaida 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.
PubMed 16829804Kumar 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.
PubMed 30451186Lai 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.
PubMed 31744475
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Retinal Detachment With Proliferative Vitreoretinopathy Using 3D Visualization System
- ClinicalTrials.gov ID
- NCT04490876
- Acronym / sponsor ID
- ILM / 3701001
- Conditions
- Proliferative Vitreoretinopathy
- Keywords
- Retinal Detachment, Proliferative Vitreoretinopathy, Internal Limiting Membrane, ILM peeling, Brilliant Blue G
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centro Oftalmológico Dr CharlesUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 25 Jul 2020 (actual)
- Study completion
- 25 Jul 2020 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ).
Detailed 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)
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinal Detachment with PVR | – | Procedure: 3D Pars Plana Vitrectomy associated with Extensive Brilliant Blue G-Assisted ILM Peeling MethodProliferative 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Private retina clinic.
Key inclusion criteria (1 listed)
- 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 .
Key exclusion criteria (1 listed)
- patients younger than 18 years age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Pars Plana Vitrectomy associated with Extensive Brilliant Blue G-Assisted ILM Peeling MethodAfter 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. | Procedure or surgery | Retinal Detachment with PVR |
Primary outcome
Persistent retinal reattachment
Time frame: 6 months after silicone oil removal
The anatomical success was defined as persistent retinal reattachment at the last follow-up visit (in absence of silicone oil tamponade).
2 secondary outcomes
Mean Best Corrected Visual Acuity
Time frame: mean follow-up: 14.1 months
Spectral Domain OPTICAL COHERENCE TOMOGRAPHY (SD-OCT) IMAGING of the MACULA
Time frame: mean follow-up: 14.1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Results publication: PubMed 29621507Foveau 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.
- Results publication: PubMed 20182404Odrobina 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.
- Results publication: PubMed 12644944Sakamoto 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.
- Results publication: PubMed 19107502Aras 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.
- Results publication: PubMed 16829804Enaida 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.
- Results publication: PubMed 30451186Kumar 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.
- Results publication: PubMed 31744475Lai 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proliferative Vitreoretinopathy, run by Centro Oftalmológico Dr Charles at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent retinal reattachment (time frame: 6 months after silicone oil removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04490876, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.