The ESCRS EPICAT study: Effectiveness of Periocular drug Injection in CATaract surgery

Phase 3

Recruiting

• Conditions: Cystoid macular edemaCataract

• Registration Number: DRKS00026178
• Lead Sponsor: Academic Hospital Maastricht (azM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 808

Inclusion Criteria

Patients can be included:
- who are undergoing routine phacoemulsification;
- who are 21 years or older;
- who should be able to communicate properly and understand instructions.

Exclusion Criteria

All ophthalmic exclusion criteria are applicable to the study eye only, unless stated otherwise.
Exclusion criteria for participation in this study are:
- 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., perioculair 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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of clinically significant CME peaks at approximately 4-6 weeks postoperatively. Therefore, the primary study endpoint of this study is the difference between treatment groups in central subfield mean macular thickness (CSMT) at six weeks postoperatively, after correction for baseline values. Retinal thickness will be measured on SD-OCT in accordance with the ETDRS retinal thickness map, which includes the central subfield mean macular thickness in the central 1.0 mm area.