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Postoperative Cystoid Macular EdemaPhase 4SOAPNCT03383328

Study for Optimizing Anti-inflammatory Prophylaxis

A Phase 4 study testing NSAID + prednisolone, preoperative, NSAID + prednisolone, postoperative and NSAID, preoperative in people with Postoperative Cystoid Macular Edema and Irvine-Gass Syndrome, run by Line Kessel at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NSAID + prednisolone, preoperative, NSAID + prednisolone, postoperative and NSAID, preoperative
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
470 participants
Where
1 siteDenmark
Study dates
1 Feb 2018to 18 Dec 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Ophthalmology

    Glostrup Municipality, Capital Region, 2600

Other trials in Denmark

About this study

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

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.

Being tested
NSAID + prednisolone, preoperative, NSAID + prednisolone, postoperative, NSAID, preoperative, NSAID, postoperative, Drop-less surgery
Keywords
Cataract, Cataract Surgery
Medical subject headings
Macular Edema, Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NSAID + prednisolone, preoperativeDrug

    Also called Group a1

    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, postoperativeDrug

    Also called Group a2

    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, preoperativeDrug

    Also called Group b1

    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, postoperativeDrug

    Also called Group b2

    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 surgeryDrug

    Also called Group c

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

Study groups in NCT03383328
Study groupRoleWhat they receive
NSAID + prednisolone, preoperativeActive comparatorCombination 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
Receives: Drug: NSAID + prednisolone, preoperative
NSAID + prednisolone, postoperativeActive comparatorCombination 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
Receives: Drug: NSAID + prednisolone, postoperative
NSAID, preoperativeExperimentalNSAID 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
Receives: Drug: NSAID, preoperative
NSAID, postoperativeExperimentalNSAID 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
Receives: Drug: NSAID, postoperative
Drop-less surgeryExperimentalA 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.
Receives: Drug: Drop-less surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Central macular thickness

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

    Measured: 3 months

Secondary outcomes (6)

  1. Best corrected visual acuity

    Postoperative best corrected visual acuity in logarithm to the minimal angle of resolution (logMAR)

    Measured: 3 days, 3 weeks and 3 months

  2. Intraocular pressure

    Change in intraocular pressure

    Measured: 3 days, 3 weeks and 3 months

  3. Optical nerve damage

    Optical nerve damage, assessed by measuring retinal nerve fiber layer (RNFL) by peripapillary optical coherence tomography (OCT)

    Measured: 3 weeks and 3 months

  4. Flare and number of cells

    Flare and number of cells measured by laser flare-cell photometry

    Measured: 3 days

  5. 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.

    Measured: 3 days and 3 weeks

  6. Patient related outcome measures

    Visual function questionnaires are filled out at baseline and 3 months after surgery

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2017
  2. Study start1 Feb 2018
  3. Primary completion18 Dec 2019
  4. Study completion18 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
470 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03383328
Sponsor's protocol ID
SOAP1
Acronym
SOAP
Status last verified
Dec 2019
First submitted
19 Dec 2017
Last updated
20 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34383010

  • 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.

    PubMed 33086290

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing NSAID + prednisolone, preoperative, NSAID + prednisolone, postoperative and NSAID, preoperative in people with Postoperative Cystoid Macular Edema and Irvine-Gass Syndrome, run by Line Kessel at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central macular thickness (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03383328, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.

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