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Study for Optimizing Anti-inflammatory Prophylaxis

NCT03383328 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2019-12-20

No results posted yet for this study

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.

Conditions

  • Postoperative Cystoid Macular Edema
  • Irvine-Gass Syndrome

Interventions

DRUG

NSAID + prednisolone, preoperative

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.

DRUG

NSAID + prednisolone, postoperative

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.

DRUG

NSAID, preoperative

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

DRUG

NSAID, postoperative

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

DRUG

Drop-less surgery

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

Sponsors & Collaborators

  • Line Kessel

    lead OTHER

Principal Investigators

  • Line Kessel, MD, Ph.D. · Dpt. of Ophthalmology, Rigshospitalet-Glostrup

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2019-12-18
Completion
2019-12-18

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03383328 on ClinicalTrials.gov