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

NCT02646072 | Completed Phase 4

• 1 other identifier: 20148-494
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystoid Macular Edema, Postoperative; Diabetes Mellitus

Keywords

diabetes mellitus; aqueous humor; inflammatory cytokines; cystoid macular edema, postoperative; nonsteroidal anti-inflammatory drugs

Outcome Measures

Primary Outcomes (1)

• Level of aqueous inflammatory cytokines post treatment as assessed using Bio-plex Pro Assays

  Aqueous samples were analyzed at the same after complete samples collection.

  9 months

Secondary Outcomes (1)

• Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography

  9 months

Study Arms (4)

Diabetes mellitus patients

ACTIVE COMPARATOR

Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery

Drug: Ketorolac tromethamine ophthalmic solution 0.45%

Diabetes mellitus control patients

NO INTERVENTION

Topical refresh plus four times a day for 3 days prior to cataract surgery

Non diabetic patients

ACTIVE COMPARATOR

Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery

Drug: Ketorolac tromethamine ophthalmic solution 0.45%

Non diabetic control patients

NO INTERVENTION

Topical refresh plus four times a day for 3 days prior to cataract surgery

Interventions

Ketorolac tromethamine ophthalmic solution 0.45% DRUG

Indicated for the treatment of pain and inflammation following cataract surgery.

Also known as: Acuvail

Diabetes mellitus patients; Non diabetic patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Smoker
• Presence of immune disease, local or systemic inflammation
• Presence of retinal diseases, glaucoma
• Previous surgical procedure on the eye
• Intra-operative complications

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (16)

• 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.

  PMID: 22511846 BACKGROUND

• 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.

  PMID: 23922491 BACKGROUND

• 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.

  PMID: 24319335 BACKGROUND

• 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.

  PMID: 22094296 BACKGROUND

• 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.

  PMID: 24264034 BACKGROUND

• 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.

  PMID: 24336915 BACKGROUND

• 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.

  PMID: 17720069 BACKGROUND

• 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.

  PMID: 18165083 BACKGROUND

• 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.

  PMID: 18599019 BACKGROUND

• 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.

  PMID: 21992076 BACKGROUND

• 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.

  PMID: 19934822 BACKGROUND

• 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.

  PMID: 19784389 BACKGROUND

• 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.

  PMID: 16433713 BACKGROUND

• 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.

  PMID: 21121809 BACKGROUND

• 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.

  PMID: 18294608 BACKGROUND

• 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.

  PMID: 23449512 BACKGROUND

MeSH Terms

Conditions

Macular Edema; Diabetes Mellitus

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yin Peng Lai, MOphthal

  University of Malaya

  PRINCIPAL INVESTIGATOR

• Mohammadreza Peyman, Mophthal

  University of Malaya

  STUDY CHAIR

• Tajunisah Iqbal, FRCS Ophth

  University of Malaya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2015
• First Posted: January 5, 2016
• Study Start: August 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

MY (1)