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

Completed

• Conditions: Macular Holes; Epiretinal Membrane

• Registration Number: NCT05086588
• Lead Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

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.

Detailed Description

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).

Study Timeline

• Study Start: 2018-04-04
• Primary Completion: 2020-06-12
• Study Completion: 2020-06-12
• Study First Submitted: 2021-09-24
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-07
• Last Update Submitted: 2021-10-07
• Study First Posted: 2021-10-21
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Staining Ability of ILM	Intra-Operatively	Staining of ILM is assed after dye injection with choosing Excellent/Good/ Needs to Improve by surgeon
Change from Baseline to 1 Month, 3 Months and 6 Months in CMT (Central Macular Thickness)	Pre-Op, 1 Month, 3 Month and 6 Month	CMT (Central Macular Thickness) in micron meters is accessed with ocular coherence tomography
Change from Baseline to 1 Month, 3 Months and 6 Months in TMV ( Total Macular Volume)	Pre-Op, 1 Month, 3 Month and 6 Month	TMV ( Total Macular Volume) in cubic millimeter is accessed with ocular coherence tomography
Change from Baseline to 1 Month, 3 Months and 6 Months in SFCT (sub foveal choroidal thickness)	Pre-Op, 1 Month, 3 Month and 6 Month	SFCT (sub foveal choroidal thickness) in cubic meter is accessed with ocular coherence tomography
Change from Baseline to 1 Month, 3 Months and 6 Months in Intra-retinal cuff pathology segmentation	Pre-Op, 1 Month, 3 Month and 6 Month	Intra-retinal cuff pathology segmentation in micron meter is accessed with ocular coherence tomography
Change from Baseline to 6 Month in Fundus auto fluorescence (FAF)	Pre-Op, 6 Month	Fundus auto fluorescence (FAF) are assed with FFA(Fundus Fluorescein Angiography)
Change from Baseline to 1 Month, 3 Months and 6 Months in RNFL Thickness (Retinal Nerve Fiber Layer)	Pre-Op, 1 Month, 3 Month and 6 Month	RNFL Thickness (Retinal Nerve Fiber Layer) in micron meter is accessed with ocular coherence tomography
Change from Baseline to 1 Month, 3 Months and 6 Months in Hole diameter	Pre-Op, 1 Month, 3 Month and 6 Month	Hole diameter in micron meter is accessed with ocular coherence tomography
Change from Baseline to 1 Month, 3 Months and 6 Months in Optic Disc situation	Pre-Op, 1 Month, 3 Month and 6 Month	Optic Disc situation is accessed with ocular coherence tomography
Change from Baseline to 6 Month in Foveal perfusion characteristics	Pre-Op, 6 Month	Foveal perfusion characteristics are assed with FFA(Fundus Fluorescein Angiography)
Change from Baseline to 6 Month in Vascular evaluation	Pre-Op, 6 Month	Vascular evaluation is assed with FFA(Fundus Fluorescein Angiography)
Multifocal ERG	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.
Overview of Adverse Events	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 Outcome Measures

Name	Time	Method
Visualization of Stained Membrane	Intra-Operatively	Visualization of Membrane is assed before and after dye injection with choosing poor/good options by surgeon
Visual Field Analyses	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.
Best Corrected Visual Acuity	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.

Trial Locations

Locations (1)

Kartal Dr. Lütfi Kirdar Şehir Hastanesi; 🇹🇷 Istanbul, Turkey