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Completed

NCT Number: NCT03383328

Study for Optimizing Anti-inflammatory Prophylaxis

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.

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Key information

Conditions

Postoperative Cystoid Macular Edema Cataract Eye Diseases Irvine-Gass Syndrome Lens Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Ophthalmology

Glostrup Municipality, Capital Region, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Group a1

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.

Other names: Group a2

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.

Other names: Group b1

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.

Other names: Group b2

Drop-less surgery

Drug

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

Other names: Group c

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Line Kessel

Other

Registry information

Official study 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

Acronym: SOAP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 26, 2017
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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