Skip to content

A study to test effectiveness and safety of a solution which expands patients eyes pupils during manual operation for cataract

Intraoperative Intracameral Mydriasis for Manual Small Incision Cataract Surgery - A Randomised Controlled Trial on efficacy, duration and postoperative inflammation - 3M

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/06/007036
Enrollment
118
Registered
2016-06-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Cataract

Interventions

Intervention1: Intracameral solution containing 0.5% lignocaine and 0.001% epinephrine: Prepared by injecting 2 ml of epinephrine solution (0.1% or 1:1000) into 50 ml solution of preservative free lig

Sponsors

M S Ramaiah Hospital medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients scheduled for elective MSICS, after screening for exclusion criteria, and after obtaining their informed consent

Exclusion criteria

Exclusion criteria: Pregnancy/breast feeding, uveitis, intake of alpha blockers, use of topical or systemic NSAIDs/prostaglandins/ miotics, presence of corneal opacities, pupillary deformities, pseudoexfoliation, past history of surgery in same eye and hypersensitivity to any component of medicines used. Any eye not dilating to at least 6 mm preoperatively, and eyes where intraoperative complications such as iris trauma or vitreous loss are encountered, will be excluded from the study

Design outcomes

Primary

MeasureTime frame
Determination of pupil diametersTimepoint: 1)Just before injecting local anaesthesia 2)Just before incision into anterior chamber 3)One minute after entry into anterior chamber 4)Just after extracting nucleus from anterior chamber to exterior 5)Just before implanting Intraocular lens 6)Just before removing eye speculum

Secondary

MeasureTime frame
Assessment of the postoperative inflammation and evaluation of patient satisfaction with the surgery through a feedback form, on first postoperative dayTimepoint: Twenty-four hours after surgery

Countries

India

Contacts

Public ContactAjay K

M. S. Ramaiah Medical College

ajayk@msrmc.ac.in08040502589

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 26, 2026