Study for Optimizing Anti-inflammatory Prophylaxis

Line Kessel470 enrolled

Overview

The purpose of this study is to investigate which anti-inflammatory treatment is best at preventing postoperative inflammation following cataract surgery. We want to compare topical prophylaxis with NSAID eye drops to topical prophylaxis with a combination of NSAID and prednisolone. We also want to compare topical prophylaxis with eye drops to drop-less surgery where the anti-inflammatory drug is administered to the subtenonal space at the conclusion of the surgical procedure. In addition, we want to investigate if topical anti-inflammatory prophylaxis should be initiated preoperatively or postoperatively. The primary outcome is change in central macular thickness, measured by optical coherence tomography, 3 months after surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

470

Conditions

Postoperative Cystoid Macular Edema Irvine-Gass Syndrome

Interventions

Ketorolactrometamol 5 mg/ml and prednisolone acetate 1% w/v eye drops are administered 3 times pr. day, starting 3 days prior to surgery and until 3 weeks after surgery.

NSAID + prednisolone, postoperativeDRUG

Ketorolactrometamol 5 mg/ml and prednisolone acetate 1% w/v eye drops are administered 3 times pr. day, starting on the day of surgery and until 3 weeks after surgery.

NSAID, preoperativeDRUG

Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting 3 days prior to surgery and until 3 weeks after surgery.

NSAID, postoperativeDRUG

Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting on the day of surgery and until 3 weeks after surgery.

Drop-less surgeryDRUG

A depot of 0.5 ml Dexamethason Krka 4 mg/ml solution for injection/infusion is administered during cataract surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with age-related cataracts * Older than 18 years * Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months. * Capacity to consent * Scheduled to undergo cataract surgery at the ophthalmic department at Rigshospitalet-Glostrup, Denmark * The surgeon must be experienced, defined by a minimum of 1000 cataract extractions completed * Only 1 eye can be included for each participant, but there are no restrictions as to whether it is the eye that undergoes surgery first or last. If both eyes of a participant are eligible, it will be decided by randomization which eye to be included in the study * Informed consent to participation Exclusion Criteria: * Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study * Medical history of epiretinal membrane, retinal vein occlusion, retinal detachment, uveitis, glaucoma, diabetes mellitus, exudative age-related macular degeneration (AMD) or AMD with geographical atrophy * Significant complications to surgery such as posterior capsule rupture/vitreous loss, choroidal hemorrhage, and dislocated lens material * Pregnancy * Fertile women, i.e. women who are not menopausal. * Women who breastfeed

Locations (1)

Department of Ophthalmology

Glostrup Municipality, Capital Region, Denmark

Outcomes

Primary Outcomes

Central macular thickness

Change in central macular thickness (CMT) measured by optical coherence tomography 3 months after cataract surgery.

Time frame: 3 months

Secondary Outcomes

Best corrected visual acuity

Postoperative best corrected visual acuity in logarithm to the minimal angle of resolution (logMAR)

Time frame: 3 days, 3 weeks and 3 months

Intraocular pressure

Change in intraocular pressure

Time frame: 3 days, 3 weeks and 3 months

Optical nerve damage

Optical nerve damage, assessed by measuring retinal nerve fiber layer (RNFL) by peripapillary optical coherence tomography (OCT)

Time frame: 3 weeks and 3 months

Flare and number of cells

Flare and number of cells measured by laser flare-cell photometry

Time frame: 3 days

Subjective patient tolerance

Subjective patient tolerance of prophylactic treatment measured on a 4-point analog scale, where 0 = no discomfort, 1 = mild discomfort, 2 = moderate discomfort and 3 = severe discomfort.

Time frame: 3 days and 3 weeks

Patient related outcome measures

Visual function questionnaires are filled out at baseline and 3 months after surgery

Time frame: 3 months

Data from ClinicalTrials.gov

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