Diabetic RetinopathyTXA-DMTRDNCT06560073
Intravenous Tranexamic Acid in Diabetic Macular TRD Surgeries
An observational study of Diabetic Retinopathy and Macular Traction Retinal Detachment, run by Ahalia Foundation Eye Hospital at 1 site in India.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetic Retinopathy, Macular Traction Retinal Detachment
- How many people
- 102 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jan 2021to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety & Results of Peroperative and Intraoperative Intravenous Tranexamic Acid in Diabetic Macular Tractional Retinal Detachment Surgeries
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?
Read the 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.
- Keywords
- tranexamic acid, diabetes mellitus, macular TRD
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of systemic adverse events
Safety of intravenous tranexamic acid
Measured: intraoperatively and postoperatively 24 hours
Secondary outcomes (9)
Number of systemic adverse events in patients having Chronic kidney disease
Safety of intravenous tranexamic acid in Patients also having Chronic Kidney Disease
Measured: intraoperatively and postoperatively 24 hours
Surgical time for vitrectomy
Surgical time for vitrectomy that is less view blurring because of intraoperative bleed
Measured: intraoperatively
Any relation between intraoperative use of Tranexamic acid and labetalol
labetalol dose needed
Measured: intraoperatively
Number of vitrectomies converted intraoperatively to bimanual technique
Highly complex surgeries
Measured: intraoperatively
Number of surgeries in which retinectomy required
Instances where it bleeds profusely and surgery could yet be completed successfully
Measured: intraoperatively
Number of surgeries in which Perfluorocarbon liquid had to be used
PFCL acts as third hand- denotes complexity of surgery
Measured: intraoperatively
Number of surgeries in which Internal Limiting Membrane peeling done
ilm peeling done after staining retina with Brilliant blue
Measured: intraoperatively
Number of eyes having preretinal bleed at the end of surgery
to find efficacy of Tranexamic acid in decreasing immediate post operative bleed
Measured: immediate postoperatively
Visual acuity change after surgery
improvement in visual acuity
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start15 Jan 2021
- Primary completion30 Apr 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahalia Foundation Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Saurav Mahajan, Ahalia Foundation Eye Hospital
- Investigators
- RAJKUMAR MAHESHWARI, MS, Study director, Ahalia Foundation Eye HospitalSAURAV MAHAJAN, MS, Principal investigator, Ahalia Foundation Eye HospitalAANCHAL MAINGI, DNB, Principal investigator, AHALIA DIABETES HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560073
- Sponsor's protocol ID
- 202101
- Other IDs
- U1111-1311-5449
- Acronym
- TXA-DMTRD
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Results of Peroperative and Intraoperative Intravenous Tranexamic Acid in Diabetic Macular Tractional Retinal Detachment Surgeries
- ClinicalTrials.gov ID
- NCT06560073
- Acronym / sponsor ID
- TXA-DMTRD / 202101
- Keywords
- tranexamic acid, diabetes mellitus, macular TRD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ahalia Foundation Eye HospitalUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of systemic adverse events
Time frame: intraoperatively and postoperatively 24 hours
Safety of intravenous tranexamic acid
9 secondary outcomes
Number of systemic adverse events in patients having Chronic kidney disease
Time frame: intraoperatively and postoperatively 24 hours
Surgical time for vitrectomy
Time frame: intraoperatively
Any relation between intraoperative use of Tranexamic acid and labetalol
Time frame: intraoperatively
Number of vitrectomies converted intraoperatively to bimanual technique
Time frame: intraoperatively
Number of surgeries in which retinectomy required
Time frame: intraoperatively
Number of surgeries in which Perfluorocarbon liquid had to be used
Time frame: intraoperatively
Number of surgeries in which Internal Limiting Membrane peeling done
Time frame: intraoperatively
Number of eyes having preretinal bleed at the end of surgery
Time frame: immediate postoperatively
Visual acuity change after surgery
Time frame: 6 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RAJKUMAR MAHESHWARI, MS study director
Ahalia Foundation Eye Hospital
SAURAV MAHAJAN, MS principal investigator
Ahalia Foundation Eye Hospital
AANCHAL MAINGI, DNB principal investigator
AHALIA DIABETES HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy and Macular Traction Retinal Detachment, run by Ahalia Foundation Eye Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of systemic adverse events (time frame: intraoperatively and postoperatively 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.