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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
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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