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Study for Optimizing Anti-inflammatory Prophylaxis (SOAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03383328
Recruitment Status : Completed
First Posted : December 26, 2017
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Line Kessel, Rigshospitalet, Denmark

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Cystoid Macular Edema Irvine-Gass Syndrome Drug: NSAID + prednisolone, preoperative Drug: NSAID + prednisolone, postoperative Drug: NSAID, preoperative Drug: NSAID, postoperative Drug: Drop-less surgery Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : December 18, 2019
Actual Study Completion Date : December 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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

 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.
Other Name: Group a1
Active Comparator: 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

 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.
Other Name: Group a2
Experimental: 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

 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.
Other Name: Group b1
Experimental: 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

 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.
Other Name: Group b2
Experimental: 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.

 Drug: Drop-less surgery
A depot of 0.5 ml Dexamethason Krka 4 mg/ml solution for injection/infusion is administered during cataract surgery.
Other Name: Group c


Outcome Measures
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Primary Outcome Measures :
  1. Central macular thickness [ Time Frame: 3 months ]
    Change in central macular thickness (CMT) measured by optical coherence tomography 3 months after cataract surgery.


Secondary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 3 days, 3 weeks and 3 months ]
    Postoperative best corrected visual acuity in logarithm to the minimal angle of resolution (logMAR)

  2. Intraocular pressure [ Time Frame: 3 days, 3 weeks and 3 months ]
    Change in intraocular pressure

  3. Optical nerve damage [ Time Frame: 3 weeks and 3 months ]
    Optical nerve damage, assessed by measuring retinal nerve fiber layer (RNFL) by peripapillary optical coherence tomography (OCT)

  4. Flare and number of cells [ Time Frame: 3 days ]
    Flare and number of cells measured by laser flare-cell photometry

  5. Subjective patient tolerance [ Time Frame: 3 days and 3 weeks ]
    Subjective patient tolerance of prophylactic treatment measured on a 4-point analog scale, where 0 = no discomfort, 1 = mild discomfort, 2 = moderate discomfort and 3 = severe discomfort.

  6. Patient related outcome measures [ Time Frame: 3 months ]
    Visual function questionnaires are filled out at baseline and 3 months after surgery


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383328


Locations
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Denmark
Department of Ophthalmology
Glostrup, Capital Region, Denmark, 2600
Sponsors and Collaborators
Line Kessel
Investigators
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Principal Investigator: Line Kessel, MD, Ph.D. Dpt. of Ophthalmology, Rigshospitalet-Glostrup
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Line Kessel, Consultant ophthalmologist, Associate Professor, MD, Ph.D., FEBO, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03383328    
Other Study ID Numbers: SOAP1
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Line Kessel, Rigshospitalet, Denmark:
Cataract
Cataract Surgery
Additional relevant MeSH terms:
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Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Anti-Inflammatory Agents, Non-Steroidal
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents