Effect of Preoperative Topical Ketorolac on Aqueous Cytokine Levels and Macular Thickness in Cataract Surgery Patients

Overview

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.

Full Title of Study: “The Effect of Preoperative Topical Ketorolac 0.45% on Aqueous Cytokine Levels and Macular Thickness in Diabetic and Non Diabetic Patients Undergoing Cataract Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2015

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.

Interventions

  • Drug: Ketorolac tromethamine ophthalmic solution 0.45%
    • Indicated for the treatment of pain and inflammation following cataract surgery.

Arms, Groups and Cohorts

  • Active Comparator: Diabetes mellitus patients
    • Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery
  • 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
  • No Intervention: Non diabetic control patients
    • Topical refresh plus four times a day for 3 days prior to cataract surgery

Clinical Trial Outcome Measures

Primary Measures

  • Level of aqueous inflammatory cytokines post treatment as assessed using Bio-plex Pro Assays
    • Time Frame: 9 months
    • Aqueous samples were analyzed at the same after complete samples collection.

Secondary Measures

  • Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography
    • Time Frame: 9 months

Participating in This Clinical Trial

Inclusion Criteria

Diabetic patient group 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:

1. Smoker 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Malaya
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lai Yin Peng, MD, Principal Investigator – University of Malaya
  • Overall Official(s)
    • Yin Peng Lai, MOphthal, Principal Investigator, University of Malaya
    • Mohammadreza Peyman, Mophthal, Study Chair, University of Malaya
    • Tajunisah Iqbal, FRCS Ophth, Study Director, University of Malaya

References

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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.

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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.

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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.

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