Dropless cataract surgery with a single subconjunctival triamcinolone injection versus topical steroid: a randomised controlled trial assessing effects on central macular thickness.
Prospective randomized non-inferiority trial evaluating the efficacy of a single subconjunctival triamcinolone acetonide injection compared with topical prednisolone acetate/phenylephrine hydrochloride in reducing central macular thickness change after cataract surgery.
Bayside Health
300 participants
Jul 1, 2026
Interventional
Conditions
Summary
This study is comparing two different ways to prevent cystoid macular oedema at the back of the eye after cataract surgery. One group will receive a single injection of a steroid (triamcinolone) under the white of the eye during the operation, while the other group will use steroid eye drops (Prednefrin Forte) four times a day for four weeks. The main question is whether the single injection is as good as the eye drops at preventing an increase in macular thickness three weeks after surgery. Researchers will also check effects on eye pressure, inflammation inside the eye, vision, and any side effects. The study hopes to show that the injection method (a “dropless” approach) works just as well as the standard eye drops, which may be more convenient for patients.
Eligibility
Inclusion Criteria3
- Patients who have a cataractous lens according to the lens opacities grading system III
- Postcode is within geographical area of Melbourne
- Pt is at least 18 years of age
Exclusion Criteria11
- Prior history of uveitis, corneal disease that is not dry eye disease or pterygium, endophthalmitis, or history of steroid response (IOP rise with ocular steroid administration)
- History of glaucoma requiring >2 pressure lowering agents, or any pressure lowering drops with the exception of a prostaglandin analogue or alpha agonist
- Any prior history of significant macular disease which may cause confusion with interpreting OCT or may mimic post operative cystoid macular oedema including advanced macular degeneration, geographic atrophy, chronic serous retinopathy and epiretinal membranes > stage 2 as per Govetto et al.’s grading system (Govetto et al., 2017)
- Any prior history of retinal disease which may increase the risk of post-operative cystoid macular oedema including history of cystoid macular oedema in either eye, current or previous diabetic macular oedema anywhere on 3D macular OCT scan, moderate or severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, neovascular age related macular degeneration or retinal vein occlusion .
- Significant/moderate drusen impacting OCT reading
- Dense or brunescent cataract which prevents a pre-operative OCT being acquired
- Non-elective surgery
- Any previous intra-ocular surgery to the study eye
- Patients on systemic anti-inflammatory therapy (not including NSAID or paracetamol use)
- Patients who develop significant intra-operative complications including posterior capsule rupture
- Currently pregnant or planning to conceive in the near future (female patients)
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Interventions
Intervention: Subconjunctival triamcinolone acetonide injection Brief name: Single intraoperative subconjunctival triamcinolone acetonide (TA) 5 mg injection (dropless arm). Drug details: International Non-proprietary Name (INN): Triamcinolone acetonide Dose: 5 mg (0.5 mL of 10 mg/mL solution). Duration of administration: Single dose only. Mode of administration: Subconjunctival injection. Description: The intervention consists of a single 0.5 mL subconjunctival injection of triamcinolone acetonide (TA) 10 mg/mL (Kenacort A10), delivering 5 mg of TA, administered in the subconjunctival plane at least 6 mm below the limbus. The injection is given immediately after completion of routine phacoemulsification cataract surgery and intraocular lens implantation. Prior to the TA injection, 0.2 mL of 2 % lignocaine is instilled subconjunctivally for local analgesia. No additional topical, intracameral, or intraocular steroids are given to participants in this arm, and Prednefrin Forte eye drops are not prescribed. The injection is performed by a RANZCO-accredited ophthalmologist or ophthalmology registrar within Bayside Health's operating theatres. No further doses are administered during the 12-week study follow-up. The dose, volume, concentration, and injection site are fixed by protocol for all participants. Strategies to ensure fidelity of the intervention: A pamphlet outlining the correct administration of the intervention medication will be provided to all involved operating theatres to ensure the technique is uniform across all patients randomised to the intervention arm. Additionally, at the 2 week post operative review, the operation report within the patient electronic medical record will be reviewed by a clinician to ensure they recieved the correct dose of the intervention medication.
Locations(1)
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ACTRN12626000516381