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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-04

Study Completion Date

2020-06-12

Brief Summary

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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

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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).

Conditions

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Macular Holes Epiretinal Membrane

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.)

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Aysu Karatay Arsan

Assoc. Prof. MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aysu Karatay Arsan, MD

Role: PRINCIPAL_INVESTIGATOR

KARTAL DR. LÜTFİ KIRDAR ŞEHİR HASTANESİ

Locations

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Kartal Dr. Lütfi Kirdar Şehir Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BTOPL-BBG-001

Identifier Type: -

Identifier Source: org_study_id