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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.
Selective Laser Trabeculoplasty (SLT) is a widely used procedure introduced by Latina and Park in 1995 for the management of various forms of glaucoma, including open-angle glaucoma (OAG), pigmentary glaucoma, pseudoexfoliation glaucoma, and ocular hypertension. SLT helps prevent irreversible blindness by effectively managing these conditions. However, postoperative management strategies vary among practitioners, with some prescribing NSAIDs, a combination of NSAIDs and steroids, or no treatment at all. There is no consensus on the most effective and safest approach.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual acuity will be measured using a Snellen chart and reported in logMAR units at each follow-up visit. The study will compare changes in visual acuity among the three treatment groups to determine the impact of each postoperative strategy on visual function. | Baseline to 1 year post-SLT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharan Bains, MD | Contact | (905) 573-7777 | 38504 | bainss@mcmaster.ca |
| Enitan A Sogbesan, MD | Contact | (905) 573-7777 | 38311 | bainss@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Enitan A Sogbesan, MD | St. Joseph's Healthcare Hamilton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare Hamilton, Hamilton Regional Eye Institute | Hamilton | Ontario | L8G 4X3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19492005 | Background | 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. | |
| 11815354 |
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The decision to share individual participant data (IPD) with other researchers is currently under consideration. The final decision will be made in alignment with institutional policies and ethical guidelines to ensure the protection of participant confidentiality and the integrity of the study.
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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.
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| 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. |
|
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| Anterior Chamber Inflammation |
Anterior chamber inflammation will be assessed using the Standardization of Uveitis Nomenclature (SUN) Working Group grading system. The presence and severity of cells and flare in the anterior chamber will be evaluated at each follow-up visit to compare the anti-inflammatory effects of the treatment strategies. |
| Baseline to 1 year post-SLT |
| Patient-Reported Discomfort | Patient discomfort will be recorded at each follow-up visit. Participants will rate their discomfort on a scale, allowing for comparison of patient comfort levels across the three treatment groups. | Baseline to 1 year post-SLT |
| Incidence of Postoperative Complications | The incidence of postoperative complications, such as ocular discomfort, conjunctival hyperemia, and corneal abrasions, will be recorded at each follow-up visit. This measure will help determine the safety profile of ketorolac alone, ketorolac with fluorometholone, and no treatment following SLT. | Baseline to 1 year post-SLT |
| 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. |
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| 25135811 | 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. |
| 9822239 | 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. |
| 34575360 | 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. |
| 36259097 | 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. |
| 34524035 | 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. |
| 25234015 | 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. |
| 27552500 | 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. |
| 26834070 | 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. |
| 23371484 | 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. |
| 11297496 | 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. |
| 25113610 | 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. |
| 8695555 | 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. |
| 31444008 | 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. |
| 16113372 | 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. |
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| 22069348 | 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. |
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| 7789416 | 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. |
| 21278588 | 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. |
| 26997784 | 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. |
| 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. |
| 10928669 | Background | Park CH, Latina MA, Schuman JS. Developments in laser trabeculoplasty. Ophthalmic Surg Lasers. 2000 Jul-Aug;31(4):315-22. No abstract available. |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D009883 | Ophthalmic Solutions |
| D020911 | Ketorolac Tromethamine |
| D005469 | Fluorometholone |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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