Effectiveness of Periocular Drug Injection in CATaract Surgery

Last updated: October 31, 2024
Sponsor: Luigi Rondas
Overall Status: Terminated

Phase

3

Condition

Cystoid Macular Edema

Macular Edema

Eye Disorders/infections

Treatment

Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solution

Bromfenac

Dexamethasone

Clinical Study ID

NCT05158699
NL72427.068.19
2019-004890-21
  • Ages > 21
  • All Genders

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.

Eligibility Criteria

Inclusion

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

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 thestudy eye (e.g. diabetes mellitus, previous retinal venous occlusion, or a historyof 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 (decimalvisual acuity less than 0.3);

  • patients with a history of steroid induced IOP rise or glaucomatous visual fieldloss;

  • patients using drugs that reduce or increase the risk of macular edema (e.g.,periocular or intraocular corticosteroid, NSAID, or antivascular endothelial growthfactor (VEGF) injection; topical corticosteroid or NSAID use; systemiccorticosteroids (>= 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

Total Participants: 628
Treatment Group(s): 4
Primary Treatment: Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solution
Phase: 3
Study Start date:
October 13, 2021
Estimated Completion Date:
August 13, 2024

Study Description

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 cataract surgery, using either topical drugs (control group) or intra-/periocular injections (intervention groups).

The hypothesis of this study is that intra-/periocular anti-inflammatory drug delivery during cataract surgery is effective in preventing CME, with better health-related quality of life and improved cost-effectiveness compared to standard topical drug delivery.

The primary outcome measure is the change in central subfield mean macular thickness (CSMT) at 6 weeks postoperatively as compared to baseline. Secondary outcome measures are the incidence of CME; the incidence of clinically significant macular edema (CSME); mean corrected distance visual acuity (CDVA); para- and perifoveal thickness and total macular volume (TMV); intraocular pressure (IOP); anterior chamber inflammation; vision-related quality of life; and cost-effectiveness.

The design of this study is a European randomised controlled multicenter trial. The study population will consist of 808 patients aged 21 years or older who require cataract surgery in at least one eye. Patients with a foreseen increased risk of developing CME or ophthalmic disorders other than cataract will be excluded. Follow-up duration is 12 weeks. The study will be conducted over a period of 36 months.

Connect with a study center

  • Hospital of the Brothers of Saint John of God

    Vienna, 1020
    Austria

    Site Not Available

  • Vienna Institute for Research in Ocular Surgery, Hanusch Krankenhaus

    Vienna, A-1140
    Austria

    Site Not Available

  • Goethe University

    Frankfurt am Main, 60590
    Germany

    Site Not Available

  • Amphia

    Breda, 4818 CK
    Netherlands

    Site Not Available

  • Deventer Ziekenhuis

    Deventer, 7416SE
    Netherlands

    Site Not Available

  • Zuyderland Medisch Centrum

    Heerlen, 6419 PC
    Netherlands

    Site Not Available

  • University Eye Clinic Maastricht UMC+

    Maastricht, 6229HX
    Netherlands

    Site Not Available

  • Canisius Wilhelmina Ziekenhuis Nijmegen

    Nijmegen, 6532SZ
    Netherlands

    Site Not Available

  • Elisabeth-Twee Steden Ziekenhuis, locatie Elisabeth

    Tilburg, 5022GC
    Netherlands

    Site Not Available

  • Gelre Ziekenhuizen

    Zutphen, 7207AE
    Netherlands

    Site Not Available

  • University Hospital Coimbra

    Coimbra, 3000-075
    Portugal

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.