None listed
Conditions
Brief summary
Intravitreal injections (injection of medication into the jelly-like fluid inside the eyeball) are commonly used to treat a range of eye diseases, including age-related macular degeneration, diabetic eye disease, retinal vein occlusions, and severe eye infections. Although these injections are generally safe and effective, they cause a temporary rise in pressure inside the eye immediately after treatment. While this pressure increase usually resolves within an hour, there is some concern that repeated episodes of elevated pressure may contribute to longer-term damage to the eye, particularly in patients requiring frequent injections or those with pre-existing glaucoma. Previous studies suggest that simple techniques such as scleral indentation (gentle pressure applied to the white part of the eye) may reduce these short-term pressure spikes. However, the existing evidence is limited, and the best timing and effectiveness of scleral indentation remain unclear. This is a clinical crossover study, in which patients who normally receive intravitreal injections will be randomised to receive scleral indentation after their injection at two of their treatment visits and standard care at two of their visits in a randomised order. This unique method allows the researchers to compare the intraocular pressure outcomes within the same individual. The findings will help determine whether scleral indentation is an effective way to reduce eye pressure rises after injections, which could benefit a substantial number of patients.
Interventions
Patients who normally receive intravitreal injections will be randomised to receive either scleral indentation or standard care (no indentation) at two of their treatment visits and standard care at two of their visits in a randomised order. There are four possible treatment sequences to which participants may be randomised: Sequence A (Indentation, Standard Care, Indentation, Standard Care), Sequence B (Standard Care, Indentation, Standard Care, Indentation), Sequence C (Indentation, Indentatio
Patients who normally receive intravitreal injections will be randomised to receive either scleral indentation or standard care (no indentation) at two of their treatment visits and standard care at two of their visits in a randomised order. There are four possible treatment sequences to which participants may be randomised: Sequence A (Indentation, Standard Care, Indentation, Standard Care), Sequence B (Standard Care, Indentation, Standard Care, Indentation), Sequence C (Indentation, Indentation, Standard Care, Standard Care), or Sequence D (Standard Care, Standard Care, Indentation, Indentation). Treatment visit frequency will be individualised based on the ocular condition being treated (typically 8-12 weekly intervals). In this study, scleral indentation will involve continuous compression of both the injection site and corneal limbus for 20 seconds, with the swab applied parallel to the injection site and limbus and force applied toward the limbus. The swab is soaked in 0.4% oxybuprocaine hydrochloride for 5-10 seconds prior. The amount of pressure applied should be sufficient to create a visible circular indentation of the globe.The indentation will be applied by the ophthalmologist who administered the intravitreal injection, who will be timed by an assistant (e.g. assisting nurse).
Sponsors
UNSW
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged at least 18 years. • Receiving routine intravitreal anti-VEGF injections for a TGA-approved indication, expected to continue for at least another 4 injections.
Exclusion criteria
• Inability to provide informed consent (including cognitive impairment impairing capacity and insufficient English language proficiency) • Active ocular infection or inflammation, including endophthalmitis, keratitis, significant uveitis, or severe conjunctivitis. • Any ocular condition where scleral indentation may be unsafe or inappropriate, such as severe scleral thinning, scleritis, significant scleral buckle- related concerns, or known globe fragility. • Prior allergic reaction to oxybuprocaine.
Outcome results
None listed