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

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ClinicalTrials.gov Identifier: NCT03946267
Recruitment Status : Completed
First Posted : May 10, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Salvatore Cillino, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

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 40 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 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

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.




Primary Outcome Measures :
  1. Postoperative macular hole closure rate and morphology [ Time Frame: twelve months ]
    Evaluated by swept-source OCT (Topcon DRI OCT Triton Series)

  2. 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)

  3. 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)

  4. 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)



Information from the National Library of Medicine

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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.

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
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Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90127
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Investigators
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Principal Investigator: Salvatore Cillino, MD, PhD AOUP Paolo Giaccone, Palermo

Publications:

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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     History of Changes
Other Study ID Numbers: 11/2016
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Retinal Perforations
Retinal Diseases
Eye Diseases