Efficacy of NSAID vs. Steroid-NSAID Combo Post-Selective Laser Trabeculoplasty: Phase 4, Single-Center RCT
NCT ID: NCT06498440
Last Updated: 2024-07-12
Study Results
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Basic Information
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NOT_YET_RECRUITING
PHASE4
126 participants
INTERVENTIONAL
2024-09-01
2025-07-01
Brief Summary
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Detailed Description
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This phase 4 single-centre randomized controlled trial seeks to address this knowledge gap by comparing the postoperative effects of ketorolac alone, a combination of ketorolac and fluorometholone, and a no treatment control group on inflammation and patient comfort following SLT. The hypothesis is that treatment with ketorolac alone or in combination with fluorometholone will show superior results in reducing inflammation and improving patient comfort compared to no treatment.
The study will enroll patients undergoing SLT at the Hamilton Regional Eye Clinic. Participants will be randomized into either one of two treatment groups or one control group (no treatment) and monitored for changes in IOP, visual acuity, patient comfort, and the occurrence of any complications over a one-year period. Data collected from these assessments will be analyzed to determine the comparative efficacy and safety of the three strategies.
Inclusion criteria include adults diagnosed with open-angle glaucoma, IOP greater than 16 mmHg, and visual acuity of 20/200 or better. Exclusion criteria include recent ocular surgeries, allergies to ketorolac or fluorometholone, and pregnancy. The primary outcome measure is the change in IOP from baseline, while secondary outcomes include visual acuity, anterior chamber inflammation, and patient-reported discomfort.
The trial follows CONSORT guidelines to maintain transparency and reproducibility. Ethical approval will be obtained from the Hamilton Integrated Research Ethics Board (HiREB), ensuring compliance with ethical and legal requirements.
The results of this study will inform postoperative care decisions following SLT, potentially leading to improved patient outcomes and satisfaction. This trial also aims to contribute to a more standardized postoperative management protocol for SLT, enhancing clinical practice and patient care in glaucoma treatment.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Ketorolac Alone
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.
Ketorolac 0.5% Eye Drops
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.
Ketorolac with Fluorometholone
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.
Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops
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.
No Treatment Control
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.
No interventions assigned to this group
Interventions
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Ketorolac 0.5% Eye Drops
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.
Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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St. Joseph's Healthcare Hamilton
OTHER
Responsible Party
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Enitan Sogbesan
Dr. Enitan Sogbesan, Principal Investigator
Principal Investigators
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Enitan A Sogbesan, MD
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Healthcare Hamilton
Locations
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St. Joseph's Healthcare Hamilton, Hamilton Regional Eye Institute
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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
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/
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol. 1996 May;80(5):389-93. doi: 10.1136/bjo.80.5.389.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Park CH, Latina MA, Schuman JS. Developments in laser trabeculoplasty. Ophthalmic Surg Lasers. 2000 Jul-Aug;31(4):315-22. No abstract available.
Other Identifiers
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17189
Identifier Type: -
Identifier Source: org_study_id
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