Effectiveness of Periocular Drug Injection in CATaract Surgery (EPICAT)

Luigi Rondas

Status and phase: Terminated; Phase 3

Conditions: Cataract; Macular Edema; Retinal Disease; Cystoid Macular Edema; Eye Diseases; Lens Diseases

Treatments: Drug: Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solution; Drug: Triamcinolone Acetonide; Drug: Dexamethasone; Drug: Bromfenac

Study type: Interventional

Funder types: Other

Identifiers

NCT05158699

2019-004890-21 (EudraCT Number)

NL72427.068.19

Details and patient eligibility

About

Cystoid macular edema (CME) is a major cause of suboptimal postoperative visual acuity after cataract surgery. Topical steroidal and nonsteroidal anti-inflammatory drugs (NSAIDs) are used to prevent CME. However, noncompliance with eye drops may compromise the effectiveness of treatment. Dropless periocular drug delivery during cataract surgery may improve the outcomes and cost-effectiveness of cataract surgery, and may alleviate the burden on homecare organizations.

Full description

In a recent European multicentre study (PREvention of Macular EDema after cataract surgery; PREMED), it was demonstrated that the combination of topical corticosteroids and NSAIDs results in the lowest risk of developing CME after cataract surgery. However, noncompliance with eye drops may compromise the effectiveness of treatment. Noncompliance is often unintentional and related to forgetfulness or incorrect instillation, particularly in the elderly cataract surgery population.

The objective of this study is to evaluate the effectiveness of different treatments to prevent CME after cataract surgery, using either topical drugs (control group) or intra-/periocular injections (intervention groups).

The hypothesis of this study is that intra-/periocular anti-inflammatory drug delivery during cataract surgery is effective in preventing CME, with better health-related quality of life and improved cost-effectiveness compared to standard topical drug delivery.

The primary outcome measure is the change in central subfield mean macular thickness (CSMT) at 6 weeks postoperatively as compared to baseline. Secondary outcome measures are the incidence of CME; the incidence of clinically significant macular edema (CSME); mean corrected distance visual acuity (CDVA); para- and perifoveal thickness and total macular volume (TMV); intraocular pressure (IOP); anterior chamber inflammation; vision-related quality of life; and cost-effectiveness.

The design of this study is a European randomised controlled multicenter trial. The study population will consist of 808 patients aged 21 years or older who require cataract surgery in at least one eye. Patients with a foreseen increased risk of developing CME or ophthalmic disorders other than cataract will be excluded. Follow-up duration is 12 weeks. The study will be conducted over a period of 36 months.

Enrollment: 628 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• who are undergoing routine phacoemulsification (one eye per patient);
• who are 21 years or older;
• who should be able to communicate properly and understand instructions.
• willing and/or able to comply with the scheduled visits and other study procedures.

Exclusion criteria

• patients who already participated with their contralateral eye;
• combined surgery (e.g. combined phacoemulsification and trabeculectomy);
• patients with an increased risk of developing cystoid macular edema (CME) in the study eye (e.g. diabetes mellitus, previous retinal venous occlusion, or a history of uveitis, macular edema, epiretinal membrane, or previous retinal surgery);
• patients who developed CME after cataract surgery in the contralateral eye;
• patients with cystoid macular changes in the study eye at baseline;
• patients with an increased risk of developing perioperative complications (e.g. Fuchs' endothelial dystrophy);
• patients with permanent moderate visual impairment in the contralateral eye (decimal visual acuity less than 0.3);
• patients with a history of steroid induced IOP rise or glaucomatous visual field loss;
• patients using drugs that reduce or increase the risk of macular edema (e.g., periocular or intraocular corticosteroid, NSAID, or antivascular endothelial growth factor (VEGF) injection; topical corticosteroid or NSAID use; systemic corticosteroids (>= 20mg prednisolon), methotrexate, biologicals, or acetazolamide), or in the previous 4 months;
• patients with a contraindication for any of the investigated drugs;
• patients who are cardiovascular unstable;
• patients who have a history of hyperthyroidism.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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628 participants in 4 patient groups

topical bromfenac & dexamethasone

Active Comparator group

Description:

bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperatively \& dexamethasone 0.1% eye drops four times daily starting two days before surgery and continuing four times daily during the first postoperative week and one drop less per day every following week.

Treatment:

Drug: Bromfenac

Drug: Dexamethasone

subconjunctival triamcinolone acetonide

Active Comparator group

Description:

one subconjunctival injection of 10 mg triamcinolone acetonide during cataract surgery (TA, Triesence/Vistrec) in the inferotemporal quadrant, 6mm from the limbus.

Treatment:

Drug: Triamcinolone Acetonide

intracameral ketorolac

Active Comparator group

Description:

intracameral injection of ketorolac tromethamine solution during cataract surgery (Omidria). A 4ml vial of Omidria (ketorolac concentration 2.88mg/ml) is added to 500ml of the irrigation solution used during cataract surgery, resulting in a ketorolac concentration of 0.023mg/ml. At the end of the surgery, the anterior chamber will be filled with the ketorolac solution.

Treatment:

Drug: Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solution

subconjunctival triamcinolone acetonide & intracameral ketorolac

Active Comparator group

Description:

one subconjunctival injection of 10 mg triamcinolone acetonide \& intracameral injection of ketorolac tromethamine solution (Omidria; 0.023mg/mL) during cataract surgery.

Treatment:

Drug: Triamcinolone Acetonide

Drug: Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solution