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Is Homatropine 5% effective in reducing pain associated with corneal abrasion when compared to placebo?

Is Homatropine 5% effective in reducing pain associated with corneal abrasion when compared to placebo?

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000648628
Enrollment
60
Registered
2005-10-17
Start date
2005-12-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Corneal abrasion or ulceration following trauma is the most common ophthalmological condition which presents to Emergency Departments. The cornea is the clear covering over the iris (coloured part of the eye) which is usually injured by objects hitting the surface of the eye (eg during grinding metal or fingernail scratches). Because of the large number of nerve endings in the cornea, surface damage is generally very painful, especially in the first 24 hours. Despite minor corneal trauma being common, the management remains controversial. There is general agreement that oral analgesics should be recommended and that topical antibiotics should be prescribed, although this has been debated. It has been thought in the past that spasm of the eye muscles around the pupil (dark part of the eye) might add to the pain which people experience after minor corneal trauma. A number of eye drops can paralyse these muscles so that this does not occur. This means that the pupil remains large and cannot alter in size in response to changes in light or attempts to focus. This leads to some light sensitivity and blurring of vision, which also occur anyway when the cornea is injured. Some text books recommend use of pupil dilating drops after corneal injury, but a recent literature review on the topic did not recommend their use because one study found no benefit. A recent survey of emergency physicians in Canada found that now only just over half of them are using dilating drops in this setting. This project aims to determine if homatropine 5% (a strong pupil dilating drop) given every six hours for a twenty-four period is effective in reducing eye pain associated with minor corneal abrasion. A total of 60 patients will be asked to participate in this study. Patients will be recruited by doctors working in the emergency department at Dandenong Hospital. Patients who satisfy the trial entry criteria will be asked to instil either homatropine 5% eye drops or hypromellose 0.5% eye drops (inactive placebo). All patients will be prescribed an antibiotic eye ointment to prevent infection in the affected eye. Patients will also be given paracetamol tablets with direction to take two tablets every six hours when required for pain. The visual analogue scale (VAS) will be used in this study to measure the level of pain in patients with corneal abrasion. Statistical analysis will involve comparing the mean pain scores at 0, 6, 12, 18 and 24 hours to find if there is a clinically significant difference between homatropine 5% and hypromellose (placebo). A reduction in VAS score of more than 20mm is considered clinically significant, so a change of this level would support future homatropine use, while a lesser change would not.

Interventions

The study will be a double blind randomised controlled trial with parallel groups receiving either the active agent (homatropine 5% eye drop).

Sponsors

Southern Health
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Corneal abrasion or ulceration from trauma (any cause, excluding chemical burn), defined as visualisation of fluorescein uptake on slit lamp examination, patient must have not undergone any prior eye examination/intervention and/or received topical therapies to the eye within 48 hours before the injury.

Exclusion criteria

Non-traumatic Corneal Ulceration such as flash burn, suspected viral or other infection, patients less than 18 years old, pregnancy, breastfeeding mothers, allergy to any medications involved in the study, glaucoma, bilateral abrasion, patients who cannot read and/or understand the patient information for whatever reason or are unwilling to give consent to participate, keratoconus.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026