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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1311-5449 | Registry Identifier | WHO UTN |
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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?
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of systemic adverse events | Safety of intravenous tranexamic acid | intraoperatively and postoperatively 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of systemic adverse events in patients having Chronic kidney disease | Safety of intravenous tranexamic acid in Patients also having Chronic Kidney Disease | intraoperatively and postoperatively 24 hours |
| Surgical time for vitrectomy |
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Inclusion Criteria:
Exclusion Criteria:
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
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diabetic patients having Macular tractional retinal detachment who visited Retina department, Ahalia foundation eye hospital, palakkad, underwent surgery and gave informed written consent to be included in study
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| Name | Affiliation | Role |
|---|---|---|
| RAJKUMAR MAHESHWARI, MS | Ahalia Foundation Eye Hospital | Study Director |
| SAURAV MAHAJAN, MS | Ahalia Foundation Eye Hospital | Principal Investigator |
| AANCHAL MAINGI, DNB | AHALIA DIABETES HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahaliafoundation Eye Hospital | Palakkad | Kerala | 678557 | India |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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Surgical time for vitrectomy that is less view blurring because of intraoperative bleed
| intraoperatively |
| Any relation between intraoperative use of Tranexamic acid and labetalol | labetalol dose needed | intraoperatively |
| Number of vitrectomies converted intraoperatively to bimanual technique | Highly complex surgeries | intraoperatively |
| Number of surgeries in which retinectomy required | Instances where it bleeds profusely and surgery could yet be completed successfully | intraoperatively |
| Number of surgeries in which Perfluorocarbon liquid had to be used | PFCL acts as third hand- denotes complexity of surgery | intraoperatively |
| Number of surgeries in which Internal Limiting Membrane peeling done | ilm peeling done after staining retina with Brilliant blue | intraoperatively |
| Number of eyes having preretinal bleed at the end of surgery | to find efficacy of Tranexamic acid in decreasing immediate post operative bleed | immediate postoperatively |
| Visual acuity change after surgery | improvement in visual acuity | 6 months postoperatively |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |