Effect of Preoperative Topical Ketorolac on Aqueous Cytokine Levels and Macular Thickness in Cataract Surgery Patients
NCT ID: NCT02646072
Last Updated: 2016-01-05
Study Results
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Basic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2014-08-31
2015-06-30
Brief Summary
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Detailed Description
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To compare the macular thickness changes in diabetic and non diabetic patients treated with preoperative ketorolac tromethamine 0.45% and its correlation with the aqueous inflammatory cytokines.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Diabetes mellitus patients
Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery
Ketorolac tromethamine ophthalmic solution 0.45%
Indicated for the treatment of pain and inflammation following cataract surgery.
Diabetes mellitus control patients
Topical refresh plus four times a day for 3 days prior to cataract surgery
No interventions assigned to this group
Non diabetic patients
Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery
Ketorolac tromethamine ophthalmic solution 0.45%
Indicated for the treatment of pain and inflammation following cataract surgery.
Non diabetic control patients
Topical refresh plus four times a day for 3 days prior to cataract surgery
No interventions assigned to this group
Interventions
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Ketorolac tromethamine ophthalmic solution 0.45%
Indicated for the treatment of pain and inflammation following cataract surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Type 2 diabetes mellitus with no diabetic retinopathy
2. If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
3. Listed for phacoemulsification cataract surgery
Non diabetic patient group
1. No history of diabetes
2. If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
3. Listed for phacoemulsification cataract surgery
Exclusion Criteria
2. Presence of immune disease, local or systemic inflammation
3. Presence of retinal diseases, glaucoma
4. Previous surgical procedure on the eye
5. Intra-operative complications
18 Years
90 Years
ALL
Yes
Sponsors
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University of Malaya
OTHER
Responsible Party
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Lai Yin Peng, MD
Principal Investigator
Principal Investigators
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Yin Peng Lai, MOphthal
Role: PRINCIPAL_INVESTIGATOR
University of Malaya
Mohammadreza Peyman, Mophthal
Role: STUDY_CHAIR
University of Malaya
Tajunisah Iqbal, FRCS Ophth
Role: STUDY_DIRECTOR
University of Malaya
Locations
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University of Malaya
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
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References
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Cheung CM, Vania M, Ang M, Chee SP, Li J. Comparison of aqueous humor cytokine and chemokine levels in diabetic patients with and without retinopathy. Mol Vis. 2012;18:830-7. Epub 2012 Apr 4.
Dong N, Xu B, Wang B, Chu L. Study of 27 aqueous humor cytokines in patients with type 2 diabetes with or without retinopathy. Mol Vis. 2013 Aug 4;19:1734-46. Print 2013.
Chu L, Wang B, Xu B, Dong N. Aqueous cytokines as predictors of macular edema in non-diabetic patients following uncomplicated phacoemulsification cataract surgery. Mol Vis. 2013 Nov 24;19:2418-25. eCollection 2013.
Yilmaz T, Cordero-Coma M, Gallagher MJ. Ketorolac therapy for the prevention of acute pseudophakic cystoid macular edema: a systematic review. Eye (Lond). 2012 Feb;26(2):252-8. doi: 10.1038/eye.2011.296. Epub 2011 Nov 18.
Schoenberger SD, Kim SJ, Sheng J, Calcutt MW. Reduction of vitreous prostaglandin E2 levels after topical administration of ketorolac 0.45%. JAMA Ophthalmol. 2014 Feb;132(2):150-4. doi: 10.1001/jamaophthalmol.2013.5692.
Schoenberger SD, Kim SJ, Shah R, Sheng J, Cherney E. Reduction of interleukin 8 and platelet-derived growth factor levels by topical ketorolac, 0.45%, in patients with diabetic retinopathy. JAMA Ophthalmol. 2014 Jan;132(1):32-7. doi: 10.1001/jamaophthalmol.2013.6203.
Henderson BA, Kim JY, Ament CS, Ferrufino-Ponce ZK, Grabowska A, Cremers SL. Clinical pseudophakic cystoid macular edema. Risk factors for development and duration after treatment. J Cataract Refract Surg. 2007 Sep;33(9):1550-8. doi: 10.1016/j.jcrs.2007.05.013.
Almeida DR, Johnson D, Hollands H, Smallman D, Baxter S, Eng KT, Kratky V, ten Hove MW, Sharma S, El-Defrawy S. Effect of prophylactic nonsteroidal antiinflammatory drugs on cystoid macular edema assessed using optical coherence tomography quantification of total macular volume after cataract surgery. J Cataract Refract Surg. 2008 Jan;34(1):64-9. doi: 10.1016/j.jcrs.2007.08.034.
Wittpenn JR, Silverstein S, Heier J, Kenyon KR, Hunkeler JD, Earl M; Acular LS for Cystoid Macular Edema (ACME) Study Group. A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients. Am J Ophthalmol. 2008 Oct;146(4):554-560. doi: 10.1016/j.ajo.2008.04.036. Epub 2008 Jul 2.
Bucci FA Jr, Waterbury LD. A randomized comparison of to-aqueous penetration of ketorolac 0.45%, bromfenac 0.09% and nepafenac 0.1% in cataract patients undergoing phacoemulsification. Curr Med Res Opin. 2011 Dec;27(12):2235-9. doi: 10.1185/03007995.2011.626018. Epub 2011 Oct 12.
Heier JS, Awh CC, Busbee BG, Waterbury LD, Daniel P, Stoller GL, Cleary TS. Vitreous nonsteroidal antiinflammatory drug concentrations and prostaglandin E2 levels in vitrectomy patients treated with ketorolac 0.4%, bromfenac 0.09%, and nepafenac 0.1%. Retina. 2009 Oct;29(9):1310-3. doi: 10.1097/IAE.0b013e3181b094e6.
Ozturk BT, Bozkurt B, Kerimoglu H, Okka M, Kamis U, Gunduz K. Effect of serum cytokines and VEGF levels on diabetic retinopathy and macular thickness. Mol Vis. 2009 Sep 19;15:1906-14.
Hanifi-Moghaddam P, Kappler S, Seissler J, Muller-Scholze S, Martin S, Roep BO, Strassburger K, Kolb H, Schloot NC. Altered chemokine levels in individuals at risk of Type 1 diabetes mellitus. Diabet Med. 2006 Feb;23(2):156-63. doi: 10.1111/j.1464-5491.2005.01743.x.
Oh IK, Kim SW, Oh J, Lee TS, Huh K. Inflammatory and angiogenic factors in the aqueous humor and the relationship to diabetic retinopathy. Curr Eye Res. 2010 Dec;35(12):1116-27. doi: 10.3109/02713683.2010.510257.
Bressler NM, Edwards AR, Antoszyk AN, Beck RW, Browning DJ, Ciardella AP, Danis RP, Elman MJ, Friedman SM, Glassman AR, Gross JG, Li HK, Murtha TJ, Stone TW, Sun JK; Diabetic Retinopathy Clinical Research Network. Retinal thickness on Stratus optical coherence tomography in people with diabetes and minimal or no diabetic retinopathy. Am J Ophthalmol. 2008 May;145(5):894-901. doi: 10.1016/j.ajo.2007.12.025. Epub 2008 Feb 21.
Gharbiya M, Cruciani F, Cuozzo G, Parisi F, Russo P, Abdolrahimzadeh S. Macular thickness changes evaluated with spectral domain optical coherence tomography after uncomplicated phacoemulsification. Eye (Lond). 2013 May;27(5):605-11. doi: 10.1038/eye.2013.28. Epub 2013 Mar 1.
Other Identifiers
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20148-494
Identifier Type: -
Identifier Source: org_study_id
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