Clinical trial NCT05086588: Safety and Efficacy Evaluation of Two Different Brilliant Blue G Dyes as Staining Agent in Vitreo Retinal Surgery.
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Holes
Epiretinal Membrane
Keywords: Brilliant Blue G Dye
ILM Pealing
Macular Hole
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-10-21
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were underwent Macular Surgery using study devices were included in the study

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Staining Ability of ILM
timeFrame: Intra-Operatively
measure: Change from Baseline to 1 Month, 3 Months and 6 Months in CMT (Central Macular Thickness)
timeFrame: Pre-Op, 1 Month, 3 Month and 6 Month
measure: Change from Baseline to 1 Month, 3 Months and 6 Months in TMV ( Total Macular Volume)
timeFrame: Pre-Op, 1 Month, 3 Month and 6 Month
measure: Change from Baseline to 1 Month, 3 Months and 6 Months in SFCT (sub foveal choroidal thickness)
timeFrame: Pre-Op, 1 Month, 3 Month and 6 Month
measure: Change from Baseline to 1 Month, 3 Months and 6 Months in Intra-retinal cuff pathology segmentation
timeFrame: Pre-Op, 1 Month, 3 Month and 6 Month
measure: Change from Baseline to 1 Month, 3 Months and 6 Months in RNFL Thickness (Retinal Nerve Fiber Layer)
timeFrame: Pre-Op, 1 Month, 3 Month and 6 Month
measure: Change from Baseline to 1 Month, 3 Months and 6 Months in Hole diameter
timeFrame: Pre-Op, 1 Month, 3 Month and 6 Month
measure: Change from Baseline to 1 Month, 3 Months and 6 Months in Optic Disc situation
timeFrame: Pre-Op, 1 Month, 3 Month and 6 Month
measure: Change from Baseline to 6 Month in Foveal perfusion characteristics
timeFrame: Pre-Op, 6 Month
measure: Change from Baseline to 6 Month in Vascular evaluation
timeFrame: Pre-Op, 6 Month
measure: Change from Baseline to 6 Month in Fundus auto fluorescence (FAF)
timeFrame: Pre-Op, 6 Month
measure: Multifocal ERG
timeFrame: Pre-op, 1 Month, 3 Month and 6 Month
measure: Overview of Adverse Events
timeFrame: Through study completion, an average of 6 Months
Secondary outcomes:
measure: Visualization of Stained Membrane
timeFrame: Intra-Operatively
measure: Visual Field Analyses
timeFrame: Pre-op, 1 Month, 3 Month and 6 Month
measure: Best Corrected Visual Acuity
timeFrame: Pre-op, 1 Month, 3 Month and 6 Month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kartal Dr. Lütfi Kirdar Şehir Hastanesi
Study officials:
affiliation: KARTAL DR. LÜTFİ KIRDAR ŞEHİR HASTANESİ
name: Aysu Karatay Arsan, MD
role: PRINCIPAL_INVESTIGATOR
References: