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Dropless cataract surgery: assessing the safety of intracameral antibiotics and subconjunctival steroid bolus injections

Dropless cataract surgery: assessing the safety and efficacy of intracameral antibiotics and subconjunctival steroid bolus injections on post-operative inflammation

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000521527
Enrollment
300
Registered
2024-04-26
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

None listed

Brief summary

In this study, we will assess the efficacy and safety of a dropless regimen in adequately controlling post-operative inflammation after cataract surgery. This study is a prospective, single-centre, non-randomized single-arm interventional study aiming to evaluate the tolerability of phacoemulsification without post-operative anti-inflammatory and antibiotics. This study will be conducted at the Royal Adelaide Hospital.

Interventions

Over a 6-month period, the intervention will involve patients undergoing standard phacoemulsification cataract surgery in the operating suites at the Royal Adelaide Hospital, with a subconjunctival triamcinolone acetonide (KENACORT) injection (40mg/mL) administered at the end of the surgical procedure. An intracameral injection of antibiotics (1mg/mL cefazolin) will also be administered immediately afterwards in all cases for endophthalmitis prophylaxis and those with known cefazolin allergies w

Over a 6-month period, the intervention will involve patients undergoing standard phacoemulsification cataract surgery in the operating suites at the Royal Adelaide Hospital, with a subconjunctival triamcinolone acetonide (KENACORT) injection (40mg/mL) administered at the end of the surgical procedure. An intracameral injection of antibiotics (1mg/mL cefazolin) will also be administered immediately afterwards in all cases for endophthalmitis prophylaxis and those with known cefazolin allergies will be treated with intracameral moxifloxacin or vancomycin. These injections will be administered by an ophthalmologist. Following surgery, all patients will have at least a 3-month post-operative follow-up period. Follow-up will be performed on day 1, day 7, day 30 and day 60. Patients receiving routine topical corticosteroid drops will be included as control arm subjects. Strategies to monitor adherence to the intervention include checking the patient surgical records.

Sponsors

Prof WengOnn Chan
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Inclusion criteria for this study includes patients over 18 years’ of age who are scheduled to undergo phacoemulsification cataract surgery in the Ophthalmology outpatient department or inpatient setting at the Royal Adelaide Hospital between a designated to be announced (TBA) 6-month period.

Exclusion criteria

Exclusion criteria for this study includes pregnant patients, patients with prior intraocular surgery, history of steroid-responsive glaucoma, diabetes mellitus and intraoperative complications such as vitreous loss, zonular dialysis and posterior capsular rupture.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026