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Search / Trial NCT05158699

Effectiveness of Periocular Drug Injection in CATaract Surgery

Launched by LUIGI RONDAS · Dec 2, 2021

Trial Information

Current as of May 02, 2025

Terminated

Keywords

Prevention

ClinConnect Summary

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 catara...

Gender

ALL

Eligibility 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.

About Luigi Rondas

Luigi Rondas is a dedicated clinical trial sponsor focused on advancing medical research and innovation. With a commitment to improving patient outcomes, the organization collaborates with healthcare professionals and research institutions to design and execute high-quality clinical studies. Luigi Rondas emphasizes adherence to ethical standards and regulatory compliance, ensuring the integrity of its trials and the safety of participants. Through rigorous methodologies and a patient-centric approach, the sponsor aims to contribute valuable insights to the medical community and facilitate the development of effective therapies.

Locations

Frankfurt Am Main, , Germany

Heerlen, , Netherlands

Vienna, , Austria

Coimbra, , Portugal

Deventer, , Netherlands

Vienna, , Austria

Maastricht, , Netherlands

Nijmegen, , Netherlands

Tilburg, , Netherlands

Zutphen, , Netherlands

Breda, , Netherlands

Patients applied

0 patients applied

Trial Officials

Nienke Visser, Dr.

Principal Investigator

Universiteitskliniek voor Oogheelkunde Maastricht UMC+

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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