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Completed

NCT Number: NCT05086588

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

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

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Key information

Conditions

Macular Holes Epiretinal Membrane Eye Diseases Retinal Diseases Retinal Perforations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kartal Dr. Lütfi Kirdar Şehir Hastanesi

Istanbul, 34865, Turkey (Türkiye)

About this study

The study was designed as prospective, open label, comparative observational study. The patients over 18 years old and undergone Macular Surgery, Internal Limiting membrane removal surgery or vitreomacular traction using the two brilliant blue G dyes as staining agent in Vitro Retinal Surgery were planned to enroll the study. Two blue G dyes (Bio Blue 90 plus and ILM Blue) was randomly assigned at the subject's initial intraoperative visit, according to a computer-generated randomization schedule. During the pars plana vitrectomy, Bio Blue 90 Plus or ILM Blue dyes were injected into eye to stain ILM. Injected Dye was removed from the eye at the end of study before injecting long term tamponade. A total of 5 visits were conducted during the study. Out of them pre-operative visit was done on 1 visit, Surgery/Intraoperative visit and thereafter there were three follow-up visits. The follow- up visits were performed at 1 month, 3 months and 6 Months after the completion of Surgery. Clinical evaluation will be done recording and using staining Ability of ILM (Intra-Operatively), Visualization of Stained Membrane (Intra-Operatively),OCT parameters: (Pre-Op & Post-Op Follow-Up), FFA parameters: (Pre-Op & Post-Op Follow-Up),Fundus auto fluorescence (FAF), Multifocal ERG (Pre-Op & Post-Op Follow-Up) and Visual Field analyses (Pre-Op & Post-Op Follow-Up).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Standard exclusion criteria for Macular Surgery like trauma history, previous macular surgery, rhegmatogenous retinal detachment together with macular hole, myopia higher than 10 diopter (D), macular hole for more than 2 years and previous retinal vessel disease.
  • Participated in any study during the use of the study device.

Treatment and study plan

Primary outcomes

  1. Staining Ability of ILM

    Time frame: Intra-Operatively

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

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

    Time frame: Pre-Op, 1 Month, 3 Month and 6 Month

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

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

    Time frame: Pre-Op, 1 Month, 3 Month and 6 Month

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

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

    Time frame: Pre-Op, 1 Month, 3 Month and 6 Month

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

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

    Time frame: Pre-Op, 1 Month, 3 Month and 6 Month

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

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

    Time frame: Pre-Op, 1 Month, 3 Month and 6 Month

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

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

    Time frame: Pre-Op, 1 Month, 3 Month and 6 Month

    Hole diameter in micron meter is accessed with ocular coherence tomography

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

    Time frame: Pre-Op, 1 Month, 3 Month and 6 Month

    Optic Disc situation is accessed with ocular coherence tomography

  9. Change from Baseline to 6 Month in Foveal perfusion characteristics

    Time frame: Pre-Op, 6 Month

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

  10. Change from Baseline to 6 Month in Vascular evaluation

    Time frame: Pre-Op, 6 Month

    Vascular evaluation is assed with FFA(Fundus Fluorescein Angiography)

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

    Time frame: Pre-Op, 6 Month

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

  12. Multifocal ERG

    Time frame: Pre-op, 1 Month, 3 Month and 6 Month

    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.

  13. Overview of Adverse Events

    Time frame: Through study completion, an average of 6 Months

    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.

Secondary outcomes

  1. Visualization of Stained Membrane

    Time frame: Intra-Operatively

    Visualization of Membrane is assed before and after dye injection with choosing poor/good options by surgeon

  2. Visual Field Analyses

    Time frame: Pre-op, 1 Month, 3 Month and 6 Month

    A test that measures the extent and distribution of the field of vision. A visual field test is done via automated perimetry.

  3. Best Corrected Visual Acuity

    Time frame: Pre-op, 1 Month, 3 Month and 6 Month

    Monocular visual acuity for each eye is be assessed using ETDRS charts held at 4 M.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

A Prospective, Open-label, Comparative Clinical Study to Evaluate the Safety and Efficacy of BIO-BLUE 90 PLUS With ILM-Blue® as Staining Agent in Vitreo Retinal Surgery.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 21, 2021
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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