Effectiveness of Periocular Drug Injection in CATaract Surgery

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Luigi Rondas
• Collaborator: European Society of Cataract and Refractive Surgeons
• Treatments: BB 1101; Bromfenac; Dexamethasone; Dexamethasone acetate; Ketorolac; Ophthalmic Solutions; Pharmaceutical Solutions; Phenylephrine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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.