Safety and Efficacy Evaluation of Two Different Brilliant Blue G Dyes as Staining Agent in Vitreo… (NCT05086588) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy Evaluation of Two Different Brilliant Blue G Dyes as Staining Agent in Vitreo Retinal Surgery.
Turkey (Türkiye)86 participantsStarted 2018-04-04
Plain-language summary
This is a prospective, Open-label, comparative clinical study to asses two brilliant blue G dyes as staining agent in Vitro Retinal Surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Staining Ability of ILM
Timeframe: Intra-Operatively
2
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
3
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
4
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
5
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
6
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
7
Change from Baseline to 1 Month, 3 Months and 6 Months in Hole diameter
Trial details
NCT IDNCT05086588
SponsorDr. Lutfi Kirdar Kartal Training and Research Hospital