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).
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the change in central subfield mean macular thickness
(CSMT) at 6 weeks postoperative as compared to the baseline preoperative.
Secondary outcome
The secundary endpoints 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;
visionrelated quality of life;
cost-effectiveness.
Background summary
In Europe, over 4 million cataract surgeries are performed each year. Cystoid
macular edema (CME) is a major cause of suboptimal postoperative visual acuity.
Topical steroidal and nonsteroidal anti-inflammatory drugs (NSAIDs) are used to
prevent CME. In a recent European multicentre study (PREvention of Macular
EDema after cataract surgery; PREMED), we 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. Dropless periocular drug delivery during surgery
may improve outcomes and cost-effectiveness, and may alleviate the burden on
homecare organizations.
Study objective
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).
Study design
The design of this study is a European randomised controlled multicentre trial
with a duration of 36 months.
Intervention
All patients will receive phacoemulsification surgery for cataract and
placement of a posterior chamber intraocular lens (IOL). All patients in every
group will receive an intracameral cefuroxime injection at the end of cataract
surgery, according to ESCRS endophthalmitis prophylaxis guidelines.
Patients will receive either:
[group 1:] topical bromfenac 0.09% and topical dexamethasone disodium phosphate
0.1%. Patients will receive bromfenac 0.09% eye drops twice daily starting two
days before surgery and continuing 2 weeks postoperatively, dexamethasone
disodium phosphate 0.1% eye drops four times daily starting two days before
surgery and continuing four times daily during the first postoperative week and
one drop less per day every following week.
[group 2:] subconjunctival injection of 10 mg triamcinolone acetonide (TA)
during cataract surgery;
[group 3:] intracameral injection of ketorolac tromethamine solution (Omidria;
0.023 mg/mL) during cataract surgery.
[group 4:] subconjunctival injection of 10 mg TA and intracameral injection of
ketorolac tromethamine solution (Omidria; 0.023 mg/mL) during cataract surgery.
Study burden and risks
In this study, standard phacoemulsification techniques will be used. Most
measurements and examinations are part of the standard of care in patients who
need cataract surgery. Only the OCT measurements are not part of the standard
of care in all patients. The examinations are non-invasive, cause no
side-effects and only take a few minutes to perform. Patients will also be
asked to fill out questionnaires about their quality of vision, quality of life
and care for cataract surgery twice, which will take about 35minutes.
The follow-up of standard cataract surgery includes one preoperative and two
postoperative visits. In this study, one to possibly two extra postoperative
visit will be needed. These visits are important to have a baseline of vision
and macula compared to postoperative measurements, before CME can occur. For
this/these appointement(s), the patient will have to come to the hospital. Side
effects of the eye drops or ketorolac/phenylephrine are rare. Because high
ocular pressure happens more often after using triamcinolone acetonide
subconjunctival, the eye pressure will be measured every postoperative visit.
After completion of the study all patients will receive a gift voucher.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
All patients:
who are undergoing routine phacoemulsification;
who are 21 years or older;
who should be able to communicate properly and understand instructions.
Exclusion criteria
All ophthalmic exclusion criteria are applicable to the study eye only, unless
stated otherwise. General exclusion criteria for participation in this study
are: 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, Fuchs' endothelial dystrophy, 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; 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.,
perioculair 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. Data of subjects without a
baseline OCT of sufficient quality will be excluded from analysis. However,
these patients cannot be excluded from the study, as they already received
(part of) the study medication. In case of perioperative complications (e.g.
posterior capsule rupture, anterior vitrectomy, choroidal haemorrhage) data
will not be included in the final analysis.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-004890-21-NL |
| CCMO | NL72427.068.19 |
| Other | volgt |