Efficacy of NSAID vs. Steroid-NSAID Combo Post-Selective Laser Trabeculoplasty: Phase 4, Single-Center RCT

NCT06498440 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 17189
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial, led by Dr. Enitan A. Sogbesan at the Hamilton Regional Eye Clinic, St. Joseph's Healthcare Hamilton, aims to compare the efficacy and safety of non-steroidal anti-inflammatory drug (NSAID) ketorolac alone versus a combination of ketorolac and the corticosteroid fluorometholone, and a control group receiving no postoperative treatment. The trial will evaluate these treatment strategies following Selective Laser Trabeculoplasty (SLT) in patients with open-angle glaucoma. The primary objective is to determine the most effective postoperative management strategy to reduce inflammation, improve patient comfort, and control intraocular pressure (IOP). Participants will be randomly assigned to one of the three groups, with follow-up visits scheduled at 1 hour, 1 week, 1 month, 3 months, 6 months, and 1 year post-SLT. The study's findings aim to guide clinicians in optimizing postoperative care for better patient outcomes.

Conditions

Open Angle Glaucoma; Ocular Hypertension; Postoperative Inflammation

Keywords

Selective Laser Trabeculoplasty (SLT); Non-steroidal anti-inflammatory drugs (NSAIDs); Ketorolac; Fluorometholone; Postoperative care; Intraocular pressure (IOP); Visual acuity; Glaucoma treatment; Ophthalmology; Randomized controlled trial (RCT)

Outcome Measures

Primary Outcomes (1)

• Change in Intraocular Pressure (IOP) from Baseline

  The primary outcome measure is the mean change in intraocular pressure (IOP) from baseline to 1 year post-Selective Laser Trabeculoplasty (SLT). IOP will be measured using Goldmann applanation tonometry (GAT) at each follow-up visit. The baseline IOP is determined as the average of measurements taken on the day of SLT booking and on the day of the SLT procedure. The primary objective is to compare the effectiveness of ketorolac alone, ketorolac with fluorometholone, and no treatment in reducing IOP following SLT.

  Baseline to 1 year post-SLT

Secondary Outcomes (4)

• Visual Acuity

  Baseline to 1 year post-SLT

• Anterior Chamber Inflammation

  Baseline to 1 year post-SLT

• Patient-Reported Discomfort

  Baseline to 1 year post-SLT

• Incidence of Postoperative Complications

  Baseline to 1 year post-SLT

Study Arms (3)

Ketorolac Alone

EXPERIMENTAL

Participants in this arm will receive ketorolac 0.5% eye drops administered twice daily for one week following Selective Laser Trabeculoplasty (SLT). Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that helps reduce inflammation and alleviate pain. The purpose of this intervention is to assess the efficacy and safety of ketorolac alone in managing postoperative inflammation and patient comfort compared to other treatment strategies.

Drug: Ketorolac 0.5% Eye Drops

Ketorolac with Fluorometholone

EXPERIMENTAL

Participants in this arm will receive a combination of ketorolac 0.5% eye drops administered twice daily and fluorometholone 0.1% eye drops administered four times daily for one week following Selective Laser Trabeculoplasty (SLT). Fluorometholone is a corticosteroid that reduces inflammation by stabilizing capillary permeability and inhibiting inflammatory cell activation. This arm aims to evaluate the combined efficacy and safety of ketorolac and fluorometholone in postoperative care.

Drug: Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops

No Treatment Control

NO INTERVENTION

Participants in this arm will not receive any postoperative treatment following Selective Laser Trabeculoplasty (SLT). This control group is included to provide a baseline for comparison against the treatment groups receiving ketorolac alone or a combination of ketorolac and fluorometholone. The purpose is to assess the natural course of postoperative inflammation and patient comfort without intervention.

Interventions

Ketorolac 0.5% Eye Drops DRUG

Participants in this arm will receive ketorolac 0.5% eye drops, administered twice daily for one week following Selective Laser Trabeculoplasty (SLT). Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that works by inhibiting cyclooxygenase (COX) enzymes, which play a key role in the inflammatory process. This intervention aims to reduce postoperative inflammation and pain, promoting patient comfort and potentially improving outcomes following SLT.

Also known as: Acular, Acular LS, Acuvail

Ketorolac Alone

Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops DRUG

Participants in this arm will receive a combination of ketorolac 0.5% eye drops and fluorometholone 0.1% eye drops. Ketorolac will be administered twice daily and fluorometholone four times daily for one week following SLT. Fluorometholone is a corticosteroid that reduces inflammation by stabilizing capillary permeability and inhibiting inflammatory cell activation. The combination aims to maximize anti-inflammatory effects and enhance patient comfort, potentially leading to better postoperative outcomes compared to ketorolac alone or no treatment.

Also known as: FML, Acular, Acuvail, Fluor-Op

Ketorolac with Fluorometholone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and older.
• Diagnosed with open-angle glaucoma.
• Intraocular pressure (IOP) greater than 16 mmHg on at least two consecutive occasions separated by one month.
• Visual acuity of 20/200 or better in at least one eye.
• Provided informed consent.

You may not qualify if:

• Patients with any other ocular disorders or surgeries within the last six months.
• Allergy or intolerance to ketorolac or fluorometholone.
• Previous use of systemic ketorolac or fluorometholone in the past month.
• Pregnancy or breastfeeding.
• Patients who are unable to speak/understand English.
• Any condition that in the investigator's opinion would make participation not in the best interest of the patient or could prevent, limit, or confound the protocol-specified assessments.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton, Hamilton Regional Eye Institute

Hamilton, Ontario, L8G 4X3, Canada

Location

Related Publications (32)

• Canadian Ophthalmological Society Glaucoma Clinical Practice Guideline Expert Committee; Canadian Ophthalmological Society. Canadian Ophthalmological Society evidence-based clinical practice guidelines for the management of glaucoma in the adult eye. Can J Ophthalmol. 2009;44 Suppl 1:S7-93. doi: 10.3129/cjo44s1. No abstract available. English, French.

  PMID: 19492005 BACKGROUND

• Foster PJ, Buhrmann R, Quigley HA, Johnson GJ. The definition and classification of glaucoma in prevalence surveys. Br J Ophthalmol. 2002 Feb;86(2):238-42. doi: 10.1136/bjo.86.2.238.

  PMID: 11815354 BACKGROUND

• Zhang N, Wang J, Li Y, Jiang B. Prevalence of primary open angle glaucoma in the last 20 years: a meta-analysis and systematic review. Sci Rep. 2021 Jul 2;11(1):13762. doi: 10.1038/s41598-021-92971-w.

  PMID: 34215769 BACKGROUND

• Farkouh A, Frigo P, Czejka M. Systemic side effects of eye drops: a pharmacokinetic perspective. Clin Ophthalmol. 2016 Dec 7;10:2433-2441. doi: 10.2147/OPTH.S118409. eCollection 2016.

  PMID: 27994437 BACKGROUND

• Macsai, M., & Mojica, G. (2013). Medical Management of Ocular Surface Disease. In E. J. Holland, M. J. Mannis, & W. B. Lee (Eds.), Ocular Surface Disease: Cornea, Conjunctiva and Tear Film (pp. 271-281). W.B. Saunders. https://doi.org/10.1016/B978-1-4557-2876-3.00034-1

  BACKGROUND

• Mahmoodi AN, Patel P, Kim PY. Ketorolac. 2024 Feb 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK545172/

  PMID: 31424756 BACKGROUND

• Shin DH, Frenkel RE, David R, Cheetham JK. Effect of topical anti-inflammatory treatment on the outcome of laser trabeculoplasty. The Fluorometholone-Laser Trabeculoplasty Study Group. Am J Ophthalmol. 1996 Sep;122(3):349-54. doi: 10.1016/s0002-9394(14)72061-6.

  PMID: 8794707 BACKGROUND

• Realini T, Charlton J, Hettlinger M. The impact of anti-inflammatory therapy on intraocular pressure reduction following selective laser trabeculoplasty. Ophthalmic Surg Lasers Imaging. 2010 Jan-Feb;41(1):100-3. doi: 10.3928/15428877-20091230-18.

  PMID: 20128578 BACKGROUND

• Mermoud A, Pittet N, Herbort CP. Inflammation patterns after laser trabeculoplasty measured with the laser flare meter. Arch Ophthalmol. 1992 Mar;110(3):368-70. doi: 10.1001/archopht.1992.01080150066030.

  PMID: 1543456 BACKGROUND

• Herbort CP, Mermoud A, Schnyder C, Pittet N. Anti-inflammatory effect of diclofenac drops after argon laser trabeculoplasty. Arch Ophthalmol. 1993 Apr;111(4):481-3. doi: 10.1001/archopht.1993.01090040073033.

  PMID: 8470978 BACKGROUND

• Rebenitsch RL, Brown EN, Binder NR, Jani A, Bonham AJ, Krishna R, Pikey K. Effect of topical loteprednol on intraocular pressure after selective laser trabeculoplasty for open-angle glaucoma. Ophthalmol Ther. 2013 Dec;2(2):113-20. doi: 10.1007/s40123-013-0018-z. Epub 2013 Aug 31.

  PMID: 25135811 BACKGROUND

• Kim YY, Glover BK, Shin DH, Lee D, Frenkel RE, Abreu MM. Effect of topical anti-inflammatory treatment on the long-term outcome of laser trabeculoplasty. Fluorometholone-Laser Trabeculoplasty Study Group. Am J Ophthalmol. 1998 Nov;126(5):721-3. doi: 10.1016/s0002-9394(98)00177-9.

  PMID: 9822239 BACKGROUND

• Gracner T. Impact of Short-Term Topical Steroid Therapy on Selective Laser Trabeculoplasty Efficacy. J Clin Med. 2021 Sep 19;10(18):4249. doi: 10.3390/jcm10184249.

  PMID: 34575360 BACKGROUND

• Dahlgren T, Ayala M, Zetterberg M. The impact of topical NSAID treatment on selective laser trabeculoplasty efficacy. Acta Ophthalmol. 2023 May;101(3):266-276. doi: 10.1111/aos.15276. Epub 2022 Oct 18.

  PMID: 36259097 BACKGROUND

• Chen YS, Hung HT, Guo SP, Chang HC. Effects of anti-inflammatory treatment on efficacy of selective laser trabeculoplasty: a systematic review and meta-analysis. Expert Rev Clin Pharmacol. 2021 Dec;14(12):1527-1534. doi: 10.1080/17512433.2021.1981860. Epub 2021 Sep 24.

  PMID: 34524035 BACKGROUND

• Jinapriya D, D'Souza M, Hollands H, El-Defrawy SR, Irrcher I, Smallman D, Farmer JP, Cheung J, Urton T, Day A, Sun X, Campbell RJ. Anti-inflammatory therapy after selective laser trabeculoplasty: a randomized, double-masked, placebo-controlled clinical trial. Ophthalmology. 2014 Dec;121(12):2356-61. doi: 10.1016/j.ophtha.2014.07.017. Epub 2014 Sep 16.

  PMID: 25234015 BACKGROUND

• De Keyser M, De Belder M, De Groot V. Randomized Prospective Study of the Use of Anti-Inflammatory Drops After Selective Laser Trabeculoplasty. J Glaucoma. 2017 Feb;26(2):e22-e29. doi: 10.1097/IJG.0000000000000522.

  PMID: 27552500 BACKGROUND

• Polat J, Grantham L, Mitchell K, Realini T. Repeatability of selective laser trabeculoplasty. Br J Ophthalmol. 2016 Oct;100(10):1437-41. doi: 10.1136/bjophthalmol-2015-307486. Epub 2016 Feb 1.

  PMID: 26834070 BACKGROUND

• Avery N, Ang GS, Nicholas S, Wells A. Repeatability of primary selective laser trabeculoplasty in patients with primary open-angle glaucoma. Int Ophthalmol. 2013 Oct;33(5):501-6. doi: 10.1007/s10792-013-9729-3. Epub 2013 Jan 31.

  PMID: 23371484 BACKGROUND

• Kramer TR, Noecker RJ. Comparison of the morphologic changes after selective laser trabeculoplasty and argon laser trabeculoplasty in human eye bank eyes. Ophthalmology. 2001 Apr;108(4):773-9. doi: 10.1016/s0161-6420(00)00660-6.

  PMID: 11297496 BACKGROUND

• Wong MO, Lee JW, Choy BN, Chan JC, Lai JS. Systematic review and meta-analysis on the efficacy of selective laser trabeculoplasty in open-angle glaucoma. Surv Ophthalmol. 2015 Jan-Feb;60(1):36-50. doi: 10.1016/j.survophthal.2014.06.006. Epub 2014 Jul 2.

  PMID: 25113610 BACKGROUND

• Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol. 1996 May;80(5):389-93. doi: 10.1136/bjo.80.5.389.

  PMID: 8695555 BACKGROUND

• Groth SL, Albeiruti E, Nunez M, Fajardo R, Sharpsten L, Loewen N, Schuman JS, Goldberg JL. SALT Trial: Steroids after Laser Trabeculoplasty: Impact of Short-Term Anti-inflammatory Treatment on Selective Laser Trabeculoplasty Efficacy. Ophthalmology. 2019 Nov;126(11):1511-1516. doi: 10.1016/j.ophtha.2019.05.032. Epub 2019 Jun 6.

  PMID: 31444008 BACKGROUND

• Hodge WG, Damji KF, Rock W, Buhrmann R, Bovell AM, Pan Y. Baseline IOP predicts selective laser trabeculoplasty success at 1 year post-treatment: results from a randomised clinical trial. Br J Ophthalmol. 2005 Sep;89(9):1157-60. doi: 10.1136/bjo.2004.062414.

  PMID: 16113372 BACKGROUND

• Melamed S, Ben Simon GJ, Levkovitch-Verbin H. Selective laser trabeculoplasty as primary treatment for open-angle glaucoma: a prospective, nonrandomized pilot study. Arch Ophthalmol. 2003 Jul;121(7):957-60. doi: 10.1001/archopht.121.7.957.

  PMID: 12860797 BACKGROUND

• Ayala M, Chen E. Comparison of selective laser trabeculoplasty (SLT) in primary open angle glaucoma and pseudoexfoliation glaucoma. Clin Ophthalmol. 2011;5:1469-73. doi: 10.2147/OPTH.S25636. Epub 2011 Oct 12.

  PMID: 22069348 BACKGROUND

• Shazly TA, Smith J, Latina MA. Long-term safety and efficacy of selective laser trabeculoplasty as primary therapy for the treatment of pseudoexfoliation glaucoma compared with primary open-angle glaucoma. Clin Ophthalmol. 2010 Dec 16;5:5-10. doi: 10.2147/OPTH.S15952.

  PMID: 21311650 BACKGROUND

• Latina MA, Park C. Selective targeting of trabecular meshwork cells: in vitro studies of pulsed and CW laser interactions. Exp Eye Res. 1995 Apr;60(4):359-71. doi: 10.1016/s0014-4835(05)80093-4.

  PMID: 7789416 BACKGROUND

• Koucheki B, Hashemi H. Selective laser trabeculoplasty in the treatment of open-angle glaucoma. J Glaucoma. 2012 Jan;21(1):65-70. doi: 10.1097/IJG.0b013e3182027596.

  PMID: 21278588 BACKGROUND

• Alon S. Selective Laser Trabeculoplasty: A Clinical Review. J Curr Glaucoma Pract. 2013 May-Aug;7(2):58-65. doi: 10.5005/jp-journals-10008-1139. Epub 2013 May 9.

  PMID: 26997784 BACKGROUND

• Rothman, A. L., Delwadia, N. A., Sarwal, R., Stinnett, S. S., Lee, P. P., Herndon, L. W., & Challa, P. (2014). A Comparison of Topical Steroids Versus Non-Steroidal Anti-Inflammatory Drugs after Selective Laser Trabeculoplasty. Investigative Ophthalmology & Visual Science, 55(13), 6158-6158.

  BACKGROUND

• Park CH, Latina MA, Schuman JS. Developments in laser trabeculoplasty. Ophthalmic Surg Lasers. 2000 Jul-Aug;31(4):315-22. No abstract available.

  PMID: 10928669 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Ketorolac; Ophthalmic Solutions; Ketorolac Tromethamine; Fluorometholone

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Enitan A Sogbesan, MD

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharan Bains, MD

CONTACT

(905) 573-7777; bainss@mcmaster.ca

Enitan A Sogbesan, MD

CONTACT

(905) 573-7777; bainss@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Enitan Sogbesan, Principal Investigator

Model Details: This study is a Phase 4 single-centre randomized controlled trial (RCT) at the Hamilton Regional Eye Clinic, St. Joseph's Healthcare Hamilton. It aims to compare postoperative treatments following Selective Laser Trabeculoplasty (SLT) in open-angle glaucoma patients. Participants are randomly assigned to one of three groups: ketorolac alone, ketorolac with fluorometholone, or no treatment (control). The primary outcome is the change in intraocular pressure (IOP) from baseline to one year post-SLT, with secondary outcomes including visual acuity, inflammation, and patient-reported discomfort. Follow-up assessments occur at 1 hour, 1 week, 1 month, 3 months, 6 months, and 1 year. The study follows CONSORT guidelines and has ethical approval from the Hamilton Integrated Research Ethics Board (HiREB). The goal is to provide reliable data on effective postoperative management strategies, enhancing clinical practice in glaucoma treatment.

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: September 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)