Home » Trials » SLCTR/2024/036
Randomized blind equivalence trial to compare usefulness of pre-operative investigations in cataract surgery in Sri Lanka
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SLCTR Registration Number
SLCTR/2024/036
Date of Registration
The date of last modification
Nov 17, 2024
Scientific Title of Trial
Randomized blind equivalence trial to compare usefulness of pre-operative investigations in cataract surgery in Sri Lanka
Public Title of Trial
A Randomized Blind Equivalence Trial Comparing the Usefulness and safety of No Routine Preoperative Investigations Versus the Standard Routine Preoperative Investigations in Cataract Surgery Patients in Sri Lanka
Disease or Health Condition(s) Studied
Cataract
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1311-2280
Any other number(s) assigned to the trial and issuing authority
P/63/05/2024
What is the research question being addressed?
What is the usefulness of no routine preoperative investigations in cataract surgery patients in Sri Lanka versus standard routine preoperative investigations in terms of safety and cost effectiveness?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Healthcare providers, Outcome assessors
Control
Uncontrolled
Assignment
Parallel
Purpose
Screening
Study Phase
Not Applicable
Intervention(s) planned
Study setting - DTU of Hemas hospital pvt. ltd. Wattala and Eye unit of Wijayakumarathunge memorial hospital, Seeduwa.
Method of Randomization into study arms - Simple randomization Unit of randomization - individual patient randomization Method of sequence generation - computer-generated random number Method of allocation concealment - study participants are given a specific identity number which are known only by the research assistant
Intervention - Group A: routine testing with 12-lead electrocardiography and random blood sugar (reference treatment) Comparison – Group B: no routine preoperative testing unless the participant presents with a new or worsening condition that would warrant medical testing (new treatment)
Inclusion criteria
Males and Females with Cataract between 40-90 years
Exclusion criteria
• History of Myocardial infarction 3 months prior to surgery • Patients who need general anesthesia • Patients with severe Bronchial Asthma
Primary outcome(s)
|
1.
Cost effectiveness by calculating the incremental cost-effectiveness ratio (ICER). |
[ On the day of surgery (preoperatively, intraoperatively and postoperatively) and up to 1 month after surgery in each group ] |
|
2.
Intraoperative ocular adverse events are: Raised intraocular pressure (>22mmhg), Iris bulging, Zonular dehiscence, Dropped nucleus/lens fragments, Corneal damage, Posterior capsule rupture. |
[ On the day of surgery (preoperatively, intraoperatively and postoperatively) ] |
|
3.
The probable postoperative ocular adverse events are: corneal edema, endophthalmitis, secondary glaucoma, subluxation of intraocular lens, dislocation of intraocular lens and unexplained blurred vision. |
[ Up to 1 month after surgery in each group ] |
|
4.
The probable intraoperative and postoperative systemic adverse events are: cardiovascular events (Myocardial ischemia, Congestive heart failure, Arrhythmia, Hypertension, Hypotension, Stroke, Transient ischemic attack), Respiratory events (Respiratory failure, Bronchospasm, Oxygen desaturation, Upper respiratory tract infection, Pneumonia), Endocrine events (Hypoglycemia, Treatment for hyperglycemia in patients with diabetes), Anemia, Hypokalemia, Musculoskeletal problems, Urinary tract infection, Dermatitis, GI disturbance, Atypical chest pain. |
[ On the day of surgery (preoperatively, intraoperatively and postoperatively) and up to 1 month after surgery in each group ] |
Secondary outcome(s)
|
1.
Change in quality of life |
[ Preoperatively and 1 month post operatively ] |
|
2.
The change in visual acuity post operatively in the two groups. |
[ Preoperatively and 1 month post operatively ] |
Target number/sample size
690 in each arm
Countries of recruitment
Sri Lanka
Anticipated start date
2024-11-18
Anticipated end date
2025-10-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self Funded
Regulatory approvals
Status
Approved
Date of Approval
2024-07-09
Approval number
P/63/05/2024
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Kelaniya. |
| Institutional Address: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya, P.O Box 6, Thalagolla Road, Ragama, Sri Lanka |
| Telephone: | +94 11 2961267 |
| Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
K.A.Salvin
Doctor/Consultant ophthalmologist/ Senior lecturer
Department of Anatomy,
Faculty of Medicine,
University of Kelaniya,
P.O Box 6,
Thalagolla Road,
Ragama,
Sri Lanka
+94 11 2958219
+94 77 7356191
salvinka@gmail.com
Contact Person for Public Queries
K.A.Salvin
Doctor/Consultant ophthalmologist/ Senior lecturer
Department of Anatomy,
Faculty of Medicine,
University of Kelaniya,
P.O Box 6,
Thalagolla Road,
Ragama,
Sri Lanka
+94 11 2958219
+94 77 7356191
salvinka@gmail.com
Primary study sponsor/organization
K.A.Salvin
Doctor/Consultant ophthalmologist/ Senior lecturer
Department of Anatomy,
Faculty of Medicine,
University of Kelaniya,
P.O Box 6,
Thalagolla Road,
Ragama,
Sri Lanka
+94 77 7356191
salvinka@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Not applicable
Study protocol available
Yes
Protocol version and date
02, 14/06/2024
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
