Intravenous Tranexamic Acid in Diabetic Macular TRD Surgeries
- Conditions
- Diabetic RetinopathyMacular Traction Retinal Detachment
- Registration Number
- NCT06560073
- Lead Sponsor
- Ahalia Foundation Eye Hospital
- Brief Summary
The goal of this observational study is to learn about safety and results of peroperative and intraoperative intravenous Tranexamic acid for diabetic macular tractional detachment eye surgeries . The main question it aims to answer is:
Adverse events and their frequency? immediate postoperative bleeding incidence? effective vitrectomy time?
- Detailed Description
all Patients who agreed and gave informed consent forsurgery as well as to be included in study were included
Patients injected INTRAVENOUS TRANEXAMIC ACID 500 mg diluted to 10 ml with normal saline slowly in immediate preoperative period Accordingly, whenever bleeding was anticipated before removing active taut membranes or when bleeder was noted TXA 0.5 g was added upto maximum of 2 g. In Chronic kidney Disease patients dose was kept as maximum of 1.5 g
data analysis pack of microsoft excel will be used for statistical analysis. descriptive statistics will be applied. wherever mean of continuous variables is to be compared among subgroups, unpaired students t test will be used. To find any relationship among continuous variables , pearsons correlation or multiple regression will be used from data analysis pack of microsoft excel.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- Eyes of Diabetic patients having Macular Tractional Retinal detachment confirmed on Indirect Ophthalmoscope or B scan when associated with Vitreous hemorrhage or Optical Coherence Tomography
- Pregnancy, lactation, Oral Contraceptive use, within 6 months thromboembolic disease ,Underlying cardiac arrhythmia where anticoagulation is indicated ,Seizures Severe liver disease,previous history of variceal bleeding ,Allergic history to Tranexamic acid
Ophthalmic exclusion criteria Previous vitreoretinal surgery Combination of tractional and rhegmatogenous retinal detachment Coexisting macular hole Macular dystrophies Arterial or venous occlusions Age related macular degeneration Extensive macular scarring Posterior segment inflammation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of systemic adverse events intraoperatively and postoperatively 24 hours Safety of intravenous tranexamic acid
- Secondary Outcome Measures
Name Time Method Surgical time for vitrectomy intraoperatively Surgical time for vitrectomy that is less view blurring because of intraoperative bleed
Number of surgeries in which retinectomy required intraoperatively Instances where it bleeds profusely and surgery could yet be completed successfully
Number of surgeries in which Perfluorocarbon liquid had to be used intraoperatively PFCL acts as third hand- denotes complexity of surgery
Number of systemic adverse events in patients having Chronic kidney disease intraoperatively and postoperatively 24 hours Safety of intravenous tranexamic acid in Patients also having Chronic Kidney Disease
Any relation between intraoperative use of Tranexamic acid and labetalol intraoperatively labetalol dose needed
Number of vitrectomies converted intraoperatively to bimanual technique intraoperatively Highly complex surgeries
Number of surgeries in which Internal Limiting Membrane peeling done intraoperatively ilm peeling done after staining retina with Brilliant blue
Number of eyes having preretinal bleed at the end of surgery immediate postoperatively to find efficacy of Tranexamic acid in decreasing immediate post operative bleed
Visual acuity change after surgery 6 months postoperatively improvement in visual acuity
Trial Locations
- Locations (1)
Ahaliafoundation Eye Hospital
🇮🇳Palakkad, Kerala, India