Macular HolesNCT05086588
Safety and Efficacy Evaluation of Two Different Brilliant Blue G Dyes as Staining Agent in Vitreo Retinal Surgery.
An observational study of Macular Holes and Epiretinal Membrane, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This is a prospective, Open-label, comparative clinical study to asses two brilliant blue G dyes as staining agent in Vitro Retinal Surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Holes, Epiretinal Membrane
- Type of treatment
- Injection or infusion
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2018to 12 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were underwent Macular Surgery using study devices were included in the study
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lütfi Kirdar Şehir Hastanesi
Istanbul, 34865
About this study
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.
This is a prospective, Open-label, comparative clinical study to asses two brilliant blue G dyes as staining agent in Vitro Retinal Surgery.
Read the 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).
- Conditions
- Macular Holes, Epiretinal Membrane
- Keywords
- Brilliant Blue G Dye, ILM Pealing, Macular Hole
- Medical subject headings
- Retinal Perforations, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Staining Ability of ILM
Staining of ILM is assed after dye injection with choosing Excellent/Good/ Needs to Improve by surgeon
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Pre-Op, 6 Month
Change from Baseline to 6 Month in Vascular evaluation
Vascular evaluation is assed with FFA(Fundus Fluorescein Angiography)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 6 Months
Secondary outcomes (3)
Visualization of Stained Membrane
Visualization of Membrane is assed before and after dye injection with choosing poor/good options by surgeon
Measured: Intra-Operatively
Visual Field Analyses
A test that measures the extent and distribution of the field of vision. A visual field test is done via automated perimetry.
Measured: Pre-op, 1 Month, 3 Month and 6 Month
Best Corrected Visual Acuity
Monocular visual acuity for each eye is be assessed using ETDRS charts held at 4 M.
Measured: Pre-op, 1 Month, 3 Month and 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start4 Apr 2018
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HolesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aysu Karatay Arsan, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Aysu Karatay Arsan, MD, Principal investigator, KARTAL DR. LÜTFİ KIRDAR ŞEHİR HASTANESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086588
- Sponsor's protocol ID
- BTOPL-BBG-001
- Status last verified
- Oct 2021
- First submitted
- 24 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05086588
- Acronym / sponsor ID
- BTOPL-BBG-001
- Conditions
- Macular Holes, Epiretinal Membrane
- Keywords
- Brilliant Blue G Dye, ILM Pealing, Macular Hole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were underwent Macular Surgery using study devices were included in the study
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
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
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
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)
Change from Baseline to 6 Month in Vascular evaluation
Time frame: Pre-Op, 6 Month
Vascular evaluation is assed with FFA(Fundus Fluorescein Angiography)
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)
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.
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.
3 secondary outcomes
Visualization of Stained Membrane
Time frame: Intra-Operatively
Visual Field Analyses
Time frame: Pre-op, 1 Month, 3 Month and 6 Month
Best Corrected Visual Acuity
Time frame: Pre-op, 1 Month, 3 Month and 6 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysu Karatay Arsan, MD principal investigator
KARTAL DR. LÜTFİ KIRDAR ŞEHİR HASTANESİ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Holes and Epiretinal Membrane, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Staining Ability of ILM (time frame: Intra-Operatively). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.