Effectiveness of Periocular drug Injection in CATaract surgery

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 683

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the change in central subfield mean macular thickness<br /><br>(CSMT) at 6 weeks postoperative as compared to the baseline preoperative.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundary endpoints are:<br /><br>the incidence of CME;<br /><br>the incidence of clinically significant macular edema (CSME);<br /><br>mean corrected distance visual acuity (CDVA);<br /><br>para- and perifoveal thickness and total macular volume (TMV);<br /><br>intraocular pressure (IOP);<br /><br>anterior chamber inflammation;<br /><br>visionrelated quality of life;<br /><br>cost-effectiveness.</p><br>