Dropless Cataract Surgery RCT: Subconjunctival Triamcinolone Injection vs Topical Steroid Drops

Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers Trial registered on ANZCTR

Registration number

ACTRN12626000516381p Ethics application status

Submitted, not yet approved Date submitted

7/04/2026 Date registered

24/04/2026 Date last updated

24/04/2026 Date data sharing statement initially provided

24/04/2026 Type of registration

Prospectively registered
Titles & IDs Public title Dropless cataract surgery with a single subconjunctival triamcinolone injection versus topical steroid: a randomised controlled trial assessing effects on central macular thickness. Query! Scientific title 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. Query! Additional trial identifiers [1] 316958 0 Nil Query! Universal Trial Number (UTN) Query! Trial acronym Query! Related trial records Query!
Health condition Health condition(s) studied: Cystoid macular oedema 341401 0 Query! Steroid-induced glaucoma 341402 0 Query! Post operative uveitis 341403 0 Query! Condition category Condition code Eye 337468 337468 0 0 Query! Diseases / disorders of the eye Query!

Intervention/exposure Study type Interventional Query! Description of the intervention or exposure 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. Query! Intervention code [1] 333692 0 Prevention Query! Intervention code [2] 333693 0 Treatment: Drugs Query! Description of the comparator or control Comparator: Topical prednisolone acetate/phenylephrine hydrochloride eye drops
Brief name: Four-week regimen of Prednefrin Forte eye drops (topical steroid arm).

Drug details:
International Non-proprietary Name (INN): Prednisolone acetate and phenylephrine hydrochloride
Dose: Prednisolone acetate 1% / phenylephrine hydrochloride 0.12% (Prednefrin Forte). One drop instilled four times daily.
Duration of administration: Four weeks.
Mode of administration: Topical eye drops (self-administered).
Description:
The comparator consists of a four-week regimen of Prednefrin Forte eye drops (prednisolone acetate 1%/phenylephrine hydrochloride 0.12%). One drop is instilled four times daily into the operated eye. This regimen is not prescribed to individuals in the intervention group. The drops are self-administered by the participant at home following discharge after routine phacoemulsification cataract surgery and intraocular lens implantation. No additional topical, intracameral, or intraocular steroids are given to participants in this arm, and subconjunctival triamcinolone injection is not administered. The dose, frequency, and duration are fixed by protocol for all participants in this arm. No further doses are administered after the 4-week period during the 12-week study follow-up.

Strategies to ensure fidelity of the comparator: As is standard practice at the institution, all patients assigned to the comparator arm will be eductaed on correct drop instillation technique and the importance of adherence following the operation by either the operating surgeon or registrar. Additionally a pamphlet will be provided outlining how to self-administer the eye drops, as well as the frequency of administration. Adherence to the topical regimen will not be actively enforced, as the study aims to reflect real-world conditions. If patients require a deviation from treatment due to a complication, this will be recorded and reported in any subsequent analysis Query! Control group Active Query!
Outcomes Primary outcome [1] 344982 0 Change in central macular thickness from baseline Query! Timepoint [1] 344982 0 3 weeks (primary endpoint) and 8 weeks post intervention Query! Secondary outcome [1] 460032 0 Intra-ocular pressure difference from baseline Query! Timepoint [1] 460032 0 3 weeks and 8 weeks post intervention Query! Secondary outcome [2] 460033 0 Presence of cystoid macular oedema Query! Timepoint [2] 460033 0 3 weeks and 8 weeks following the intervention Query! Secondary outcome [3] 460036 0 Anterior chamber inflammation Query! Timepoint [3] 460036 0 3 weeks following intervention Query! Secondary outcome [4] 460037 0 Best corrected viusal acuity Query! Timepoint [4] 460037 0 3 week and 8 weeks post intervention Query! Secondary outcome [5] 460038 0 Eye discomfort Query! Timepoint [5] 460038 0 3 week and 8 weeks post intervention Query!
Eligibility Key inclusion criteria 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
Query! Minimum age 18 Years Query! Query! Maximum age No limit Query! Query! Sex Both males and females Query! Can healthy volunteers participate? No Query! Key exclusion criteria 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)
Query!
Study design Purpose of the study Prevention Query! Allocation to intervention Randomised controlled trial Query! Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures) Central randomisation through REDCap Query! Methods used to generate the sequence in which subjects will be randomised (sequence
generation) Stata Software (version 18) is used to generate a random allocation sequence to enroll eligible patients into the trial. Random permuted blocks of varying sizes (2,4,6,8) will be used to conceal allocations. Randomisation will be stratified by diabetes and ERM status to ensure balanced allocation between treatment groups Query! Masking / blinding Open (masking not used) Query! Who is / are masked / blinded?

Query! Query! Query! Query! Intervention assignment Parallel Query! Other design features Query! Phase Phase 3 / Phase 4 Query! Type of endpoint/s Safety/efficacy Query! Statistical methods / analysis The standard deviation of change in central macular thickness from baseline to follow-up at between 1 to 2 months has been estimated as 26 µm based on pilot data collected by the investigators from patients who underwent cataract surgery and were assessed using the Zeiss Cirrus OCT. Given the intersession repeatability published for the Zeiss Cirrus OCT, and the author’s clinical experience, a non-inferiority margin of 10 µm is considered to be significant (Wolf-Schnurrbusch et al., 2009). A total sample size of 232 (116 per arm) is required to establish non-inferiority with 90% power at the 5% level of significance. Non-inferiority will be demonstrated if the lower limit of the 95% confidence interval for the difference between treatment arms lies above -10 µm. Accounting for approximately 20% attrition, a total of 300 patients (150 per group) will be enrolled.

The mean change in central macular thickness from baseline to follow-up at 3 weeks will be estimated in each treatment group. Difference between groups and the corresponding 95% confidence intervals (95% CI) will be determined. Non-inferiority will be established if the lower limit of the 95% CI lies above the pre-specified non-inferiority margin of -10. Query!
Recruitment Recruitment status Not yet recruiting Query! Date of first participant enrolment Anticipated 1/07/2026 Query! Actual Query! Date of last participant enrolment Anticipated 1/11/2026 Query! Actual Query! Date of last data collection Anticipated 1/01/2027 Query! Actual Query! Sample size Target 300 Query! Accrual to date Query! Final Query! Recruitment in Australia Recruitment state(s) VIC Query! Recruitment hospital [1] 29368 0 The Alfred - Melbourne Query! Recruitment postcode(s) [1] 45686 0 3004 - Melbourne Query!
Funding & Sponsors Funding source category [1] 321554 0 Hospital Query! Name [1] 321554 0 Ophthalmology Research Fund. Alfred Hospital. Query! Country [1] 321554 0 Australia Query! Primary sponsor type Government body Query! Name Bayside Health Query! Address Query! Country Australia Query! Secondary sponsor category [1] 324343 0 None Query! Name [1] 324343 0 Query! Address [1] 324343 0 Query! Country [1] 324343 0 Query!
Ethics approval Ethics application status Submitted, not yet approved Query! Ethics committee name [1] 320088 0 Alfred Hospital Ethics Committee Query! Ethics committee address [1] 320088 0 https://www.alfredhealth.org.au/research/ethics-research-governance Query! Ethics committee country [1] 320088 0 Australia Query! Date submitted for ethics approval [1] 320088 0 08/04/2026 Query! Approval date [1] 320088 0 Query! Ethics approval number [1] 320088 0 Query!
Summary Brief 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. Query! Trial website Query! Trial related presentations / publications Query! Public notes Query!
Contacts Principal investigator Name 149390 0 Dr David van der Straaten Query! Address 149390 0 Alfred Hospital, 55 Commercial Road, Melbourne 3004, Victoria Query! Country 149390 0 Australia Query! Phone 149390 0 +61 425701051 Query! Fax 149390 0 Query! Email 149390 0 [email protected] Query! Contact person for public queries Name 149391 0 David van der Straaten Query! Address 149391 0 Alfred Hospital, 55 Commercial Road, Melbourne 3004, Victoria Query! Country 149391 0 Australia Query! Phone 149391 0 +61 425701051 Query! Fax 149391 0 Query! Email 149391 0 [email protected] Query! Contact person for scientific queries Name 149392 0 David van der Straaten Query! Address 149392 0 Alfred Hospital, 55 Commercial Road, Melbourne 3004, Victoria Query! Country 149392 0 Australia Query! Phone 149392 0 +61 425701051 Query! Fax 149392 0 Query! Email 149392 0 [email protected] Query!
Data sharing statement Will the study consider sharing individual participant data? No

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.