Study for Optimizing Anti-inflammatory Prophylaxis (SOAP)

Line Kessel

Status and phase: Completed; Phase 4

Conditions: Irvine-Gass Syndrome; Postoperative Cystoid Macular Edema

Treatments: Drug: NSAID + prednisolone, postoperative; Drug: Drop-less surgery; Drug: NSAID, preoperative; Drug: NSAID + prednisolone, preoperative; Drug: NSAID, postoperative

Study type: Interventional

Funder types: Other

Identifiers

NCT03383328

SOAP1

Details and patient eligibility

About

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.

Enrollment: 470 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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470 participants in 5 patient groups

NSAID + prednisolone, preoperative

Active Comparator group

Description:

Combination of NSAID- and prednisolone eye drops. Treatment is initiated 3 days prior to surgery and administered 3 times pr. day for 3 weeks. Ketorolactrometamol 5 mg/ml, eye drops, 1 drop 3 times pr. day Prednisolone acetate 1% w/v, eye drops, 1 drop 3 times pr. day

Treatment:

Drug: NSAID + prednisolone, preoperative

NSAID + prednisolone, postoperative

Active Comparator group

Description:

Combination of NSAID- and prednisolone eye drops. Treatment is initiated on the day of surgery and administered 3 times pr. day for 3 weeks. Ketorolactrometamol 5 mg/ml, eye drops, 1 drop 3 times pr. day Prednisolone acetate 1% w/v, eye drops, 1 drop 3 times pr. day

Treatment:

Drug: NSAID + prednisolone, postoperative

NSAID, preoperative

Experimental group

Description:

NSAID eye drops as monotherapy. Treatment is initiated 3 days prior to surgery and administered 3 times pr. day for 3 weeks. Ketorolactrometamol 5 mg/ml, eye drops, 1 drop 3 times pr. day

Treatment:

Drug: NSAID, preoperative

NSAID, postoperative

Experimental group

Description:

NSAID eye drops as monotherapy. Treatment is initiated on the day of surgery and administered 3 times pr. day for 3 weeks. Ketorolactrometamol 5 mg/ml, eye drops, 1 drop 3 times pr. day

Treatment:

Drug: NSAID, postoperative

Drop-less surgery

Experimental group

Description:

A depot of dexamethasone is administered subtenonally during surgery. Dexamethason Krka 4 mg/ml solution for injection/infusion. 0,5 ml equivalent to 2 mg of dexamethasone is administered once.

Treatment:

Drug: Drop-less surgery