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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

Randomized blind equivalence trial to compare usefulness of pre-operative investigations in cataract surgery in Sri Lanka

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2024/036
Enrollment
Unknown
Registered
2024-11-17
Start date
2024-11-18
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Interventions

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 randomiz

Sponsors

K.A.Salvin
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Males and Females with Cataract between 40-90 years

Exclusion criteria

Exclusion criteria: • History of Myocardial infarction 3 months prior to surgery • Patients who need general anesthesia • Patients with severe Bronchial Asthma

Design outcomes

Primary

MeasureTime frame
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] 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) ] 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] 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

MeasureTime frame
Change in quality of life [Preoperatively and 1 month post operatively] The change in visual acuity post operatively in the two groups. [Preoperatively and 1 month post operatively ]

Countries

Sri Lanka

Contacts

Public ContactK.A.Salvin

Doctor/Consultant ophthalmologist/ Senior lecturer

salvinka@gmail.com+94 11 2958219

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Sep 19, 2026