Clinical trial NCT03383328: Study for Optimizing Anti-inflammatory Prophylaxis
Official title: Effect of Drop-less Surgery Compared to Topical NSAID Alone and Combination of Steroid and NSAID on Central Macular Thickness After Cataract Surgery, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Cystoid Macular Edema
Irvine-Gass Syndrome
Keywords: Cataract
Cataract Surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Central macular thickness
timeFrame: 3 months
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 3 days, 3 weeks and 3 months
measure: Intraocular pressure
timeFrame: 3 days, 3 weeks and 3 months
measure: Optical nerve damage
timeFrame: 3 weeks and 3 months
measure: Flare and number of cells
timeFrame: 3 days
measure: Subjective patient tolerance
timeFrame: 3 days and 3 weeks
measure: Patient related outcome measures
timeFrame: 3 months
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Ophthalmology
state: Capital Region
Study officials:
affiliation: Dpt. of Ophthalmology, Rigshospitalet-Glostrup
name: Line Kessel, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erichsen JH, Holm LM, Forslund Jacobsen M, Forman JL, Kessel L. Prednisolone and Ketorolac vs Ketorolac Monotherapy or Sub-Tenon Prophylaxis for Macular Thickening in Cataract Surgery: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Oct 1;139(10):1062-1070. doi: 10.1001/jamaophthalmol.2021.2976.
citation: Erichsen JH, Forman JL, Holm LM, Kessel L. Effect of anti-inflammatory regimen on early postoperative inflammation after cataract surgery. J Cataract Refract Surg. 2021 Mar 1;47(3):323-330. doi: 10.1097/j.jcrs.0000000000000455.