Study for Optimizing Anti-inflammatory Prophylaxis

NCT03383328 | Completed Phase 4 DMC

• 1 other identifier: SOAP1
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cystoid Macular Edema; Irvine-Gass Syndrome

Keywords

Cataract; Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• Central macular thickness

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

  3 months

Secondary Outcomes (6)

• Best corrected visual acuity

  3 days, 3 weeks and 3 months

• Intraocular pressure

  3 days, 3 weeks and 3 months

• Optical nerve damage

  3 weeks and 3 months

• Flare and number of cells

  3 days

• Subjective patient tolerance

  3 days and 3 weeks

Study Arms (5)

NSAID + prednisolone, preoperative

ACTIVE COMPARATOR

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

Drug: NSAID + prednisolone, preoperative

NSAID + prednisolone, postoperative

ACTIVE COMPARATOR

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

Drug: NSAID + prednisolone, postoperative

NSAID, preoperative

EXPERIMENTAL

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

Drug: NSAID, preoperative

NSAID, postoperative

EXPERIMENTAL

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

Drug: NSAID, postoperative

Drop-less surgery

EXPERIMENTAL

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.

Drug: Drop-less surgery

Interventions

NSAID + prednisolone, preoperative DRUG

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.

Also known as: Group a1

NSAID + prednisolone, preoperative

NSAID + prednisolone, postoperative DRUG

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.

Also known as: Group a2

NSAID + prednisolone, postoperative

NSAID, preoperative DRUG

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

Also known as: Group b1

NSAID, preoperative

NSAID, postoperative DRUG

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

Also known as: Group b2

NSAID, postoperative

Drop-less surgery DRUG

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

Also known as: Group c

Drop-less surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Line Kessel: lead

Study Sites (1)

Department of Ophthalmology

Glostrup Municipality, Capital Region, 2600, Denmark

Location

Related Publications (2)

• 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.

  PMID: 34383010 DERIVED

• 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.

  PMID: 33086290 DERIVED

MeSH Terms

Conditions

Macular Edema; Cataract

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Prednisolone; Postoperative Period; SOXB2 Transcription Factors

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services; SOX Transcription Factors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; High Mobility Group Proteins; Chromosomal Proteins, Non-Histone; Nuclear Proteins; Nucleoproteins; Transcription Factors

Study Officials

• Line Kessel, MD, Ph.D.

  Dpt. of Ophthalmology, Rigshospitalet-Glostrup

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant ophthalmologist, Associate Professor, MD, Ph.D., FEBO

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 26, 2017
• Study Start: February 1, 2018
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

DK (1)