Clinical trial NCT06560073: Intravenous Tranexamic Acid in Diabetic Macular TRD Surgeries
Official title: Safety & Results of Peroperative and Intraoperative Intravenous Tranexamic Acid in Diabetic Macular Tractional Retinal Detachment Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Macular Traction Retinal Detachment
Keywords: tranexamic acid
diabetes mellitus
macular TRD
Lead sponsor: Ahalia Foundation Eye Hospital
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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 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

Primary outcomes:
measure: Number of systemic adverse events
timeFrame: intraoperatively and postoperatively 24 hours
Secondary outcomes:
measure: Number of systemic adverse events in patients having Chronic kidney disease
timeFrame: intraoperatively and postoperatively 24 hours
measure: Surgical time for vitrectomy
timeFrame: intraoperatively
measure: Any relation between intraoperative use of Tranexamic acid and labetalol
timeFrame: intraoperatively
measure: Number of vitrectomies converted intraoperatively to bimanual technique
timeFrame: intraoperatively
measure: Number of surgeries in which retinectomy required
timeFrame: intraoperatively
measure: Number of surgeries in which Perfluorocarbon liquid had to be used
timeFrame: intraoperatively
measure: Number of surgeries in which Internal Limiting Membrane peeling done
timeFrame: intraoperatively
measure: Number of eyes having preretinal bleed at the end of surgery
timeFrame: immediate postoperatively
measure: Visual acuity change after surgery
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Palakkad
country: India
facility: Ahaliafoundation Eye Hospital
state: Kerala
Study officials:
affiliation: Ahalia Foundation Eye Hospital
name: RAJKUMAR MAHESHWARI, MS
role: STUDY_DIRECTOR
affiliation: Ahalia Foundation Eye Hospital
name: SAURAV MAHAJAN, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: AHALIA DIABETES HOSPITAL
name: AANCHAL MAINGI, DNB
role: PRINCIPAL_INVESTIGATOR
References: