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Effectiveness of Periocular Drug Injection in CATaract Surgery

NCT05158699 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 628

Last updated 2024-11-04

No results posted yet for this study

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.

Conditions

  • Macular Edema
  • Cystoid Macular Edema
  • Retinal Disease
  • Cataract
  • Lens Diseases
  • Eye Diseases

Interventions

DRUG

Bromfenac

Bromfenac topical eye drops (Yellox)

DRUG

Dexamethasone

Dexamethasone topical eye drops

DRUG

Triamcinolone Acetonide

0.25ml of 40mg/ml (10mg) triamcinolone acetonide (Triesence/Vistrec) will be injected subconjunctivally

DRUG

Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solution

Omidria is added to the irrigation fluid used during cataract surgery. At the end of surgery, the anterior chamber will be filled with the ketorolac solution.

Sponsors & Collaborators

  • European Society of Cataract and Refractive Surgeons

    collaborator OTHER

  • Luigi Rondas

    lead OTHER

Principal Investigators

  • Nienke Visser, Dr. · Universiteitskliniek voor Oogheelkunde Maastricht UMC+

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-13
Primary Completion
2024-08-13
Completion
2024-08-13

Countries

  • Austria
  • Germany
  • Netherlands
  • Portugal

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05158699 on ClinicalTrials.gov