Safety and Efficacy Evaluation of Two Different Brilliant Blue G Dyes as Staining Agent in Vitreo Retinal Surgery.

NCT05086588 | Completed

• 1 other identifier: BTOPL-BBG-001
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, Open-label, comparative clinical study to asses two brilliant blue G dyes as staining agent in Vitro Retinal Surgery.

Conditions

Macular Holes; Epiretinal Membrane

Keywords

Brilliant Blue G Dye; ILM Pealing; Macular Hole

Outcome Measures

Primary Outcomes (13)

• Staining Ability of ILM

  Staining of ILM is assed after dye injection with choosing Excellent/Good/ Needs to Improve by surgeon

  Intra-Operatively

• Change from Baseline to 1 Month, 3 Months and 6 Months in CMT (Central Macular Thickness)

  CMT (Central Macular Thickness) in micron meters is accessed with ocular coherence tomography

  Pre-Op, 1 Month, 3 Month and 6 Month

• Change from Baseline to 1 Month, 3 Months and 6 Months in TMV ( Total Macular Volume)

  TMV ( Total Macular Volume) in cubic millimeter is accessed with ocular coherence tomography

  Pre-Op, 1 Month, 3 Month and 6 Month

• Change from Baseline to 1 Month, 3 Months and 6 Months in SFCT (sub foveal choroidal thickness)

  SFCT (sub foveal choroidal thickness) in cubic meter is accessed with ocular coherence tomography

  Pre-Op, 1 Month, 3 Month and 6 Month

• Change from Baseline to 1 Month, 3 Months and 6 Months in Intra-retinal cuff pathology segmentation

  Intra-retinal cuff pathology segmentation in micron meter is accessed with ocular coherence tomography

  Pre-Op, 1 Month, 3 Month and 6 Month

• Change from Baseline to 1 Month, 3 Months and 6 Months in RNFL Thickness (Retinal Nerve Fiber Layer)

  RNFL Thickness (Retinal Nerve Fiber Layer) in micron meter is accessed with ocular coherence tomography

  Pre-Op, 1 Month, 3 Month and 6 Month

• Change from Baseline to 1 Month, 3 Months and 6 Months in Hole diameter

  Hole diameter in micron meter is accessed with ocular coherence tomography

  Pre-Op, 1 Month, 3 Month and 6 Month

• Change from Baseline to 1 Month, 3 Months and 6 Months in Optic Disc situation

  Optic Disc situation is accessed with ocular coherence tomography

  Pre-Op, 1 Month, 3 Month and 6 Month

• Change from Baseline to 6 Month in Foveal perfusion characteristics

  Foveal perfusion characteristics are assed with FFA(Fundus Fluorescein Angiography)

  Pre-Op, 6 Month

• Change from Baseline to 6 Month in Vascular evaluation

  Vascular evaluation is assed with FFA(Fundus Fluorescein Angiography)

  Pre-Op, 6 Month

• Change from Baseline to 6 Month in Fundus auto fluorescence (FAF)

  Fundus auto fluorescence (FAF) are assed with FFA(Fundus Fluorescein Angiography)

  Pre-Op, 6 Month

• Multifocal ERG

  During multifocal ERG testing, the patient views a rapidly changing sequence on the monitor. The resulting electrical activity is recorded by an electrode, then amplified and analyzed. During stimulation the hexagons on the screen independently change every 13 milliseconds. They all follow the same pseudorandom sequence, with each hexagon starting at a slightly different position in this sequence. Using a cross-correlation technique, the software determines the retinal response from each of the 103 segments of the retina.

  Pre-op, 1 Month, 3 Month and 6 Month

• Overview of Adverse Events

  An AE could be any unfavorable and unintended symptom, sign, disease or condition, or test abnormality whether or not considered related to the investigational product. A serious adverse event (SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAE): AEs that developed/worsened during the 'on treatment period' (from first dose of study device until the end of study period). Category "AE" included participant with both serious and non-serious AE.

  Through study completion, an average of 6 Months

Secondary Outcomes (3)

• Visualization of Stained Membrane

  Intra-Operatively

• Visual Field Analyses

  Pre-op, 1 Month, 3 Month and 6 Month

• Best Corrected Visual Acuity

  Pre-op, 1 Month, 3 Month and 6 Month

Study Arms (2)

Bio Blue 90 Plus

Patients who were underwent Macular Surgery using Bio Blue 90 Plus (Brilliant Blue G Dye; 0.25 g /l concentration in 0.5 ml BD Glass Syringe; Biotech Vision Care Pvt. Ltd., Ahmedabad, India.)

ILM Blue

Patients who were underwent Macular Surgery using ILM Blue (Brilliant Blue G Dye; 0.25 g /l concentration in 0.5 ml BD Glass Syringe; D.O.R.C. Dutch Ophthalmic Research Center (International) B.V., Zuidland, The Netherlands)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who were underwent Macular Surgery using study devices were included in the study

You may qualify if:

• Over 18 years of age
• Patient undergone Macular Surgery, Epiretinal membrane removal surgery or vitreomacular traction using the study device
• Patient who can attend all the regular follow-up examinations as per the routine schedule.
• Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read signed and dated by the patient.

You may not qualify if:

• Participated in any study during the use of the study device.

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr. Lütfi Kirdar Şehir Hastanesi

Istanbul, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Retinal Perforations; Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Aysu Karatay Arsan, MD

  KARTAL DR. LÜTFİ KIRDAR ŞEHİR HASTANESİ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. MD

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 21, 2021
• Study Start: April 4, 2018
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

TU (1)