Ting 2009.
Study characteristics | |
Methods | Study design: parallel RCT Unit of randomization: individual (1 eye included) Study start date: 2 May 2006 (anticipated date on trial registry; ACTRN012605000273684) Study end date: 2 May 2007 (calculated based on the reported duration of study) Participant follow‐up time: 2 weeks Treatment time: 36 to 48 hours Time from abrasion to randomization (hours): less than 36 hours; the mean hours from injury in the tetracaine group was 13.8 hours and 15.8 hours in the saline group Power calculation: power and sample size calculations were based on a two‐tailed difference of 25% to 50%, as there has been a large variation in corneal healing rates in previous studies |
Participants | Country/countries: Australia Setting: emergency department of an urban hospital Inclusion criteria: traumatic superficial corneal abrasion with or without a retained foreign body, or keratitis from welding flash exposure Exclusion criteria: over 36 hours since corneal injury, under 18 years old, known adverse reaction to study medications, eye disease other than refractive error, contact lens use, pregnant or lactating, eye infection, functionally one‐eyed, requires urgent referral to ophthalmology (penetrating eye injury) Reported a subgroup analysis (Y/N): no Randomized (n): 47 Tetracaine 0.4% group: 22 Saline group: 25 Exclusions and loss to follow‐up (n; reasons): 31; did not attend follow‐up (22); retained foreign body/rust (2); data collected outside of follow‐up window (7) Tetracaine 0.4% group: 15; did not attend follow‐up (11); retained foreign body/rust (1); data collected outside of follow‐up window (3) Saline group: 16; did not attend follow‐up (11); retained foreign body/rust (1); data collected outside of follow‐up window (4) Analyzed (n): 16 Tetracaine 0.4% group: 7 Saline group: 9 Age (mean): overall not reported Tetracaine 0.4% group: 35.1 Saline group: 33.6 Gender (number, % female): 0 (0%) Race/ethnicity (study definition, n, %): not reported Etiology of corneal abrasion (study definition, n, %): corneal abrasion (15, 32%), corneal foreign body (20, 43%), welding flash burn (10, 21%), welding flash burn and corneal foreign body (2, 4%) Tetracaine 0.4% group: corneal abrasion (8, 36%), corneal foreign body (9, 41%), welding flash burn (4, 18%), welding flash burn and corneal foreign body (1, 5%) Saline group: corneal abrasion (7, 28%), corneal foreign body (11, 44%), welding flash burn (6, 24%), welding flash burn and corneal foreign body (1, 4%) Baseline pain (study scale): not reported |
Interventions |
Intervention: amethocaine (tetracaine) 0.4%, 1 drop hourly as needed
Comparison: normal saline 0.9%, 1 drop hourly as needed
Co‐interventions:
*Not all participants received antibiotics. Discharged with topical antibiotics for subset of participants (8/22 amethocaine; 8/18 saline group) |
Outcomes |
Primary study outcome(s):
Secondary study outcome(s):
Adverse event(s): significant functional or clinical adverse Measurement time points: baseline, 36‐ to 48‐hour ED visit, 2‐week telephone interview |
Notes | Sponsorship source: listed source of support listed differs between reports. Funding source name: Mater Foundation in trial registry (ACTRN012605000273684); no source of support reported in the full‐text publication (Ting 2009) Conflicts of interest: "none" declared Informed consent obtained?: yes Ethics approval obtained?: yes Investigator's name: Joseph Ting Affiliated institution: Department of Emergency Medicine, Mater Adults' Hospital, South Brisbane, Australia Trial registration ID: ACTRN012605000273684 |