The efficacy and safety of "Acular" eyedrops or a singular "Volon A 40" injection compared to a "no treatment" group in patients with macular edema (swelling of the retina due to accumulation of fluid) following cataract (clouding of the eye lens) surgery.

EffiCacy and safety of topical ketoroLac trOmethamine and sUbtenon triamcinolone acetonideand a “watch-and-wait” strategy for acute pseudophakic macular eDema: a randomized phase-3 trial - CLOUD

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003232-21-AT

Enrollment

249

Registered

2017-10-10

Start date

2017-10-06

Completion date

Unknown

Last updated

2020-02-01

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

Conditions

Pseudophakic macular edema

Interventions

Trade Name: Acular 0,5% Augentropfen Product Name: Acular 0,5% Augentropfen Pharmaceutical Form: Eye drops INN or Proposed INN: KETOROLAC TROMETAMOL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - =18 years of age -Pseudophakia in the study eye -No history of previous treatment of PME -Signed written informed consent -Cataract surgery =4 months in study eye -BCVA =20/125; BVCA =20/32 -Presence of PME determined by fundus examination -Presence of central macular edema determined by OCT -No sign of significant diabetic retinopathy and/or maculopathy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 224

Exclusion criteria

Exclusion criteria: -Pregnancy /Breast-feeding -Systemic treatment with corticosteroids in the preceding 14 days -Systemic treatment with NSAIDs in the preceding 14 days -Presence of any contradictions indicated in the summary of product characteristics for the use of topical ketorolac tromethamine 0.5% and subtenon triamcinolone acetonide injection -Active choroidal neovascularization -Retinal detachment -Vitreoretinal surgery in the preceding year -Myopia =8 diopters -Uncontrolled glaucoma

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of topical ketorolac tromethamine or a subtenon triamcinolone acetonide injection in subjects with pseudophakic cystoid macular edema, compared to a “watch-and-wait” strategy.;Secondary Objective: To evaluate the safety of topical ketorolac tromethamine or a subtenon triamcinolone acetonide injection in this population, compared to a "watch and wait" strategy;Primary end point(s): Change in central retinal thickness measured by OCT from baseline to week 6;Timepoint(s) of evaluation of this end point: 6 weeks after baseline	—

Measure

Time frame

Main Objective: To assess the efficacy of topical ketorolac tromethamine or a subtenon triamcinolone acetonide injection in subjects with pseudophakic cystoid macular edema, compared to a “watch-and-wait” strategy.;Secondary Objective: To evaluate the safety of topical ketorolac tromethamine or a subtenon triamcinolone acetonide injection in this population, compared to a "watch and wait" strategy;Primary end point(s): Change in central retinal thickness measured by OCT from baseline to week 6;Timepoint(s) of evaluation of this end point: 6 weeks after baseline

—

Secondary

Measure	Time frame
Secondary end point(s): -Change in BCVA (Best Corrected Visual Acuity) in ETDRS letters from baseline to week 3 and week 6 -Change in central retinal thickness measured by OCT from baseline to week 3 -Complete resolution (binary) of macular edema measured by OCT at week 3 and week 6 -Change in ocular pain assessment from baseline to week 3 and week 6 -Change in dry eye questionnaire from baseline to week 3 and week 6 ;Timepoint(s) of evaluation of this end point: Three and six weeks after baseline	—

Measure

Time frame

Secondary end point(s): -Change in BCVA (Best Corrected Visual Acuity) in ETDRS letters from baseline to week 3 and week 6 -Change in central retinal thickness measured by OCT from baseline to week 3 -Complete resolution (binary) of macular edema measured by OCT at week 3 and week 6 -Change in ocular pain assessment from baseline to week 3 and week 6 -Change in dry eye questionnaire from baseline to week 3 and week 6 ;Timepoint(s) of evaluation of this end point: Three and six weeks after baseline

—

Countries

Austria

Contacts

Public ContactUnivers. Augenklinik

Medizinische Universität Graz

laura.pertl@medunigraz.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026