Diabetic Retinopathy, Macular Traction Retinal Detachment
Conditions
Keywords
tranexamic acid, diabetes mellitus, macular TRD
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.
Interventions
None listed
Sponsors
Ahalia Foundation Eye Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of systemic adverse events | intraoperatively and postoperatively 24 hours | Safety of intravenous tranexamic acid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical time for vitrectomy | intraoperatively | Surgical time for vitrectomy that is less view blurring because of intraoperative bleed |
| 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 retinectomy required | intraoperatively | Instances where it bleeds profusely and surgery could yet be completed successfully |
| 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 |
| 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 |
| Number of surgeries in which Perfluorocarbon liquid had to be used | intraoperatively | PFCL acts as third hand- denotes complexity of surgery |
Countries
India
Outcome results
None listed