Effectiveness of Periocular Drug Injection in CATaract Surgery

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    808
  • sponsor
    Luigi Rondas
Updated on 23 December 2021
edema
triamcinolone
cataract
dexamethasone
ketorolac
macular edema
bromfenac
phacoemulsification
irrigating solutions
cystoid macular edema

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.

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.

Details
Condition Macular Edema, Cystoid Macular Edema, Retinal Disease, Cataract, Lens Diseases, Eye Diseases
Treatment Dexamethasone, triamcinolone acetonide, Bromfenac, Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solution
Clinical Study IdentifierNCT05158699
SponsorLuigi Rondas
Last Modified on23 December 2021

Eligibility

Yes No Not Sure

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
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