Effect of Preoperative Topical Ketorolac on Aqueous Cytokine Levels and Macular Thickness in Cataract Surgery Patients
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether there is a relationship between inflammatory cytokines in the aqueous of the eye and thickness of the macula after treatment of topical ketorolac for patients undergoing cataract surgery.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
To compare aqueous levels of inflammatory cytokines in diabetic and non diabetic patients treated with preoperative topical ketorolac tromethamine 0.45%.
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Diabetes mellitus patients Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery |
Drug: Ketorolac tromethamine ophthalmic solution 0.45%
Indicated for the treatment of pain and inflammation following cataract surgery.
Other Names:
|
No Intervention: Diabetes mellitus control patients Topical refresh plus four times a day for 3 days prior to cataract surgery |
|
Active Comparator: Non diabetic patients Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery |
Drug: Ketorolac tromethamine ophthalmic solution 0.45%
Indicated for the treatment of pain and inflammation following cataract surgery.
Other Names:
|
No Intervention: Non diabetic control patients Topical refresh plus four times a day for 3 days prior to cataract surgery |
Outcome Measures
Primary Outcome Measures
- Level of aqueous inflammatory cytokines post treatment as assessed using Bio-plex Pro Assays [9 months]
Aqueous samples were analyzed at the same after complete samples collection.
Secondary Outcome Measures
- Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography [9 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
Diabetic patient group
-
Type 2 diabetes mellitus with no diabetic retinopathy
-
If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
-
Listed for phacoemulsification cataract surgery
Non diabetic patient group
-
No history of diabetes
-
If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
-
Listed for phacoemulsification cataract surgery
Exclusion Criteria:
-
Smoker
-
Presence of immune disease, local or systemic inflammation
-
Presence of retinal diseases, glaucoma
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Previous surgical procedure on the eye
-
Intra-operative complications
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Malaya | Kuala Lumpur | Wilayah Persekutuan | Malaysia | 50603 |
Sponsors and Collaborators
- University of Malaya
Investigators
- Principal Investigator: Yin Peng Lai, MOphthal, University of Malaya
- Study Chair: Mohammadreza Peyman, Mophthal, University of Malaya
- Study Director: Tajunisah Iqbal, FRCS Ophth, University of Malaya
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Hanifi-Moghaddam P, Kappler S, Seissler J, Müller-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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Review.
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