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Study for Optimizing Anti-inflammatory Prophylaxis (SOAP)

Primary Purpose

Postoperative Cystoid Macular Edema, Irvine-Gass Syndrome

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
NSAID + prednisolone, preoperative
NSAID + prednisolone, postoperative
NSAID, preoperative
NSAID, postoperative
Drop-less surgery
Sponsored by
Line Kessel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Cystoid Macular Edema focused on measuring Cataract, Cataract Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Arm Label

NSAID + prednisolone, preoperative

NSAID + prednisolone, postoperative

NSAID, preoperative

NSAID, postoperative

Drop-less surgery

Arm 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

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 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 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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Best corrected visual acuity
Postoperative best corrected visual acuity in logarithm to the minimal angle of resolution (logMAR)
Intraocular pressure
Change in intraocular pressure
Optical nerve damage
Optical nerve damage, assessed by measuring retinal nerve fiber layer (RNFL) by peripapillary optical coherence tomography (OCT)
Flare and number of cells
Flare and number of cells measured by laser flare-cell photometry
Subjective patient tolerance
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.
Patient related outcome measures
Visual function questionnaires are filled out at baseline and 3 months after surgery

Full Information

First Posted
December 19, 2017
Last Updated
December 19, 2019
Sponsor
Line Kessel
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1. Study Identification

Unique Protocol Identification Number
NCT03383328
Brief Title
Study for Optimizing Anti-inflammatory Prophylaxis
Acronym
SOAP
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 18, 2019 (Actual)
Study Completion Date
December 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Line Kessel

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cystoid Macular Edema, Irvine-Gass Syndrome
Keywords
Cataract, Cataract Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
470 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NSAID + prednisolone, preoperative
Arm Type
Active Comparator
Arm 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
Arm Title
NSAID + prednisolone, postoperative
Arm Type
Active Comparator
Arm 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
Arm Title
NSAID, preoperative
Arm Type
Experimental
Arm 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
Arm Title
NSAID, postoperative
Arm Type
Experimental
Arm 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
Arm Title
Drop-less surgery
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
NSAID + prednisolone, preoperative
Other Intervention Name(s)
Group a1
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
NSAID + prednisolone, postoperative
Other Intervention Name(s)
Group a2
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
NSAID, preoperative
Other Intervention Name(s)
Group b1
Intervention Description
Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting 3 days prior to surgery and until 3 weeks after surgery.
Intervention Type
Drug
Intervention Name(s)
NSAID, postoperative
Other Intervention Name(s)
Group b2
Intervention Description
Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting on the day of surgery and until 3 weeks after surgery.
Intervention Type
Drug
Intervention Name(s)
Drop-less surgery
Other Intervention Name(s)
Group c
Intervention Description
A depot of 0.5 ml Dexamethason Krka 4 mg/ml solution for injection/infusion is administered during cataract surgery.
Primary Outcome Measure Information:
Title
Central macular thickness
Description
Change in central macular thickness (CMT) measured by optical coherence tomography 3 months after cataract surgery.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Best corrected visual acuity
Description
Postoperative best corrected visual acuity in logarithm to the minimal angle of resolution (logMAR)
Time Frame
3 days, 3 weeks and 3 months
Title
Intraocular pressure
Description
Change in intraocular pressure
Time Frame
3 days, 3 weeks and 3 months
Title
Optical nerve damage
Description
Optical nerve damage, assessed by measuring retinal nerve fiber layer (RNFL) by peripapillary optical coherence tomography (OCT)
Time Frame
3 weeks and 3 months
Title
Flare and number of cells
Description
Flare and number of cells measured by laser flare-cell photometry
Time Frame
3 days
Title
Subjective patient tolerance
Description
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.
Time Frame
3 days and 3 weeks
Title
Patient related outcome measures
Description
Visual function questionnaires are filled out at baseline and 3 months after surgery
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Line Kessel, MD, Ph.D.
Organizational Affiliation
Dpt. of Ophthalmology, Rigshospitalet-Glostrup
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology
City
Glostrup
State/Province
Capital Region
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
34383010
Citation
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.
Results Reference
derived
PubMed Identifier
33086290
Citation
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.
Results Reference
derived

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Study for Optimizing Anti-inflammatory Prophylaxis

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