Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
470 participants
INTERVENTIONAL
2018-02-01
2019-12-18
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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NSAID + prednisolone, preoperative
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
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.
NSAID + prednisolone, postoperative
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
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.
NSAID, preoperative
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
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.
NSAID, postoperative
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
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.
Drop-less surgery
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.
Drop-less surgery
A depot of 0.5 ml Dexamethason Krka 4 mg/ml solution for injection/infusion is administered during cataract surgery.
Interventions
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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.
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.
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.
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.
Drop-less surgery
A depot of 0.5 ml Dexamethason Krka 4 mg/ml solution for injection/infusion is administered during cataract surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Line Kessel
OTHER
Responsible Party
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Line Kessel
Consultant ophthalmologist, Associate Professor, MD, Ph.D., FEBO
Principal Investigators
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Line Kessel, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Dpt. of Ophthalmology, Rigshospitalet-Glostrup
Locations
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Department of Ophthalmology
Glostrup Municipality, Capital Region, Denmark
Countries
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References
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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.
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.
Other Identifiers
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SOAP1
Identifier Type: -
Identifier Source: org_study_id