Clinical trial NCT05158699: Effectiveness of Periocular Drug Injection in CATaract Surgery
Official title: The ESCRS EPICAT Study: Effectiveness of Periocular Drug Injection in CATaract Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Macular Edema
Cystoid Macular Edema
Retinal Disease
Cataract
Lens Diseases
Eye Diseases
Keywords: Prevention
Lead sponsor: Academisch Ziekenhuis Maastricht
Sponsor class: OTHER
Collaborators: name: European Society of Cataract and Refractive Surgeons
First posted: 2021-12-15
Enrollment: 628
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A block randomization procedure will be followed to acquire equal number of subjects in every treatment group. Patients are randomly allocated to 1 of 4 treatment groups in a 1:1:1:1 ratio. The various study centres will be taken into account during randomization.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Change in central subfield mean macular thickness as a measurement of efficacy
timeFrame: Baseline, 6 weeks postoperatively
Secondary outcomes:
measure: Change in central subfield mean macular thickness as a measurement of efficacy
timeFrame: Baseline, 12 weeks postoperatively
measure: No. of subjects developing clinically significant macular edema as a measurement of efficacy
timeFrame: Until 12 weeks postoperatively
measure: Change in parafoveal retinal thickness in the central inner circle (1.0 - 3.0mm) as a measurement of efficacy
timeFrame: Baseline, 6 weeks and 12 weeks postoperatively
measure: Change in perifoveal retinal thickness in the central outer circle (3.0 - 6.0mm) as a measurement of efficacy
timeFrame: Baseline, 6 weeks and 12 weeks postoperatively
measure: Change in macular volume in the central 6.0mm area as a measurement of efficacy
timeFrame: Baseline, 6 weeks and 12 weeks postoperatively
measure: Change in corrected distance visual acuity (CDVA) as a measurement of efficacy
timeFrame: Baseline, 1 week, 6 weeks, and 12 weeks postoperatively
measure: Change in Intraocular pressure (IOP) as a measurement of safety
timeFrame: Baseline, 1 week, 6 weeks, and 12 weeks postoperatively
measure: Anterior chamber inflammation as a measurement of safety
timeFrame: Baseline, 1 week , 6 weeks, and 12 weeks postoperatively
measure: No. of subjects with Adverse Events as a measurement of safety and tolerability
timeFrame: Until 12 weeks postoperatively
measure: Patient reported outcome measures (PROMs): NEI VFQ-25
timeFrame: Baseline and 12 weeks postoperatively
measure: Patient reported outcome measures (PROMs): Catquest-9SF
timeFrame: Baseline and 12 weeks postoperatively
measure: Patient reported outcome measures (PROMs): HUI3
timeFrame: Baseline and 12 weeks postoperatively
measure: Patient reported outcome measures (PROMs): EQ-5D-5L
timeFrame: Baseline and 12 weeks postoperatively
measure: Quality Adjusted Life Years (QALYs)
timeFrame: Baseline until 12 weeks postoperatively
measure: Costs per patient
timeFrame: Baseline until 12 weeks postoperatively
measure: Incremental cost-effectiveness ratios (ICERs): QALY
timeFrame: Baseline until 12 weeks postoperatively
measure: Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25
timeFrame: Baseline until 12 weeks postoperatively
measure: Incremental cost-effectiveness ratios (ICERs): Catquest
timeFrame: Baseline until 12 weeks postoperatively
measure: Incremental cost-effectiveness ratios (ICERs): Visual acuity
timeFrame: Baseline until 12 weeks postoperatively
measure: Budget impact
timeFrame: Baseline until 12 weeks postoperatively
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Hospital of the Brothers of Saint John of God
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery, Hanusch Krankenhaus
city: Frankfurt am Main
country: Germany
facility: Goethe University
city: Breda
country: Netherlands
facility: Amphia
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Maastricht
country: Netherlands
facility: University Eye Clinic Maastricht UMC+
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis Nijmegen
city: Tilburg
country: Netherlands
facility: Elisabeth-Twee Steden Ziekenhuis, locatie Elisabeth
city: Coimbra
country: Portugal
facility: University Hospital Coimbra
Study officials:
affiliation: Universiteitskliniek voor Oogheelkunde Maastricht UMC+
name: Nienke Visser, Dr.
role: PRINCIPAL_INVESTIGATOR
References: