Study Results
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Basic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2021-05-01
2022-01-01
Brief Summary
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Purpose of this study is to determine the efficacy of topical bromfenac and topical dexamethasone on intraocular concentration of interleukin-6 (IL6) and the incidence of pseudophakic cystoid macular edema (PCME) after cataract surgery in patients with nonproliferative diabetic retinopathy (NPDR).
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Detailed Description
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Current leading theory of pathogenesis of PCME (Irvine Gass) involves inflammation caused by surgical trauma which induces the release of inflammatory mediators like cytokines, prostaglandins and other vasopermeability factors, which disrupt the blood-retinal barrier and cause leakage from perifoveal retinal capillaries and accumulation of extracellular fluid in outer plexiform and inner nuclear layers of the retina. Diabetes is significant risk factor for developing PCME and grows proportionately with the severity of the diabetic retinopathy (DR). DR is common complication of diabetes mellitus (DM) and affects one in three persons with DM. Interleukin-6 (IL6) is associated with many intraocular inflammatory diseases such as diabetic retinopathy and macular edema acting as a pro-inflammatory cytokine. Levels of IL6 in aqueous humor are correlated with the severity of DR and the severity of DME. IL6 probably plays a crucial role in the development of inflammation after cataract surgery. Macular edema is usually monitored by spectral domain optical coherence tomography (SD-OCT) which is suitable for detecting subtle macular changes as well as follow up after treatment. OCT provides an objective measurement of macular thickness that correlates well with visual impairment and can be useful in standardizing definitions of PCME.
Prevention of PCME after cataract surgery in patients with NPDR include preoperative treatment with steroids, intravitreal injections of anti-vascular endothelial growth factors, laser treatment and topical nonsteroidal anti-inflammatory drugs (NSAIDs).
This randomized, double blinded, placebo-controlled trial will be conducted at Clinic of Ophthalmology, University Hospital Center Zagreb, Croatia. Ninety (90) eyes with mild to moderate NPDR (EDTRS classification) and cataract grade II nuclear/cortical or posterior subcapsular (Lens Opacities Classification System III) who will undergo phacoemulsification with intraocular lens implantation will be divided into three groups. Group 1 will receive topical bromfenac, group 2 will receive topical dexamethasone and group 3 will receive topical placebo, 7 days preoperatively and 3 weeks postoperatively. All patients will receive standard regimen of topical steroid-antibiotic drops postoperatively. Macular edema is defined as central foveal subfield thickness (CFT) increase of 40% from baseline. On the day of the surgery aqueous humor samples (0.1-0.2 mL) will be taken and IL6 concentration will be analyzed. Central foveal subfield thickness (CFT) will be measured with spectral domain optical coherence tomography (SD-OCT) and analyzed 7 days prior to surgery, on the day of the surgery and on 1, 7, 30 and 90 postoperative day.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Bromfenac
Group 1 will receive topical bromfenac (0.9 mg/mL) 2x daily, 7 days before the surgery
Bromfenac Ophthalmic 0.09% Ophthalmic Solution
topical bromfenac (0.9 mg/mL) 2x daily 7 days before the surgery
Phacoemulsification surgery (PHACO)
About 0.1-0.2 mL of aqueous humor will be collected at the beginning of the cataract surgery (PHACO) through paracentesis, aqueous will then be transported in dry ice with a dedicated box to the laboratory and stored at -80C until the analysis. IL6 concentration will be analyzed with Human IL6 Quantikine Elisa kit (R\&D System).
Dexamethasone
Group 2 will receive topical dexamethasone (1mg/mL) 2x daily before the surgery
Dexamethasone Ophthalmic
topical dexamethasone (1 mg/mL) 2x daily 7 days before the surgery
Phacoemulsification surgery (PHACO)
About 0.1-0.2 mL of aqueous humor will be collected at the beginning of the cataract surgery (PHACO) through paracentesis, aqueous will then be transported in dry ice with a dedicated box to the laboratory and stored at -80C until the analysis. IL6 concentration will be analyzed with Human IL6 Quantikine Elisa kit (R\&D System).
Placebo
Group 3 will receive topical placebo (artificial tears substitute) 2x daily before the surgery
Placebo
topical placebo (artificial tears substitute) 2x daily before the surgery
Phacoemulsification surgery (PHACO)
About 0.1-0.2 mL of aqueous humor will be collected at the beginning of the cataract surgery (PHACO) through paracentesis, aqueous will then be transported in dry ice with a dedicated box to the laboratory and stored at -80C until the analysis. IL6 concentration will be analyzed with Human IL6 Quantikine Elisa kit (R\&D System).
Interventions
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Bromfenac Ophthalmic 0.09% Ophthalmic Solution
topical bromfenac (0.9 mg/mL) 2x daily 7 days before the surgery
Dexamethasone Ophthalmic
topical dexamethasone (1 mg/mL) 2x daily 7 days before the surgery
Placebo
topical placebo (artificial tears substitute) 2x daily before the surgery
Phacoemulsification surgery (PHACO)
About 0.1-0.2 mL of aqueous humor will be collected at the beginning of the cataract surgery (PHACO) through paracentesis, aqueous will then be transported in dry ice with a dedicated box to the laboratory and stored at -80C until the analysis. IL6 concentration will be analyzed with Human IL6 Quantikine Elisa kit (R\&D System).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* senile cataract grade II nuclear/cortical or posterior subcapsular (LOCS III)
Exclusion Criteria
* posterior segment pathology (diabetic macular edema, previous diabetic macular edema treatment, previous retinal photocoagulation therapy, age related macular degeneration, retinal vascular diseases or history of uveitis)
* intraoperative complications (posterior capsular rupture, vitreus loss, intraocular lens not implanted in the capsular bag),
* postoperative complications (leaking incision, increased intraocular pressure, corneal edema or inflammation),
* therapy for glaucoma,
* patients on antihypertensive therapy, topical or systemic NSAIDs or steroids,
* previous steroid responders or hypersensitivity to the NSAID drug class,
* previous ocular trauma and intraocular surgery
18 Years
ALL
No
Sponsors
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University of Zagreb
OTHER
Klinički Bolnički Centar Zagreb
OTHER
Responsible Party
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Andjela Jukic
MD, ophthalmologist, FEBO
Principal Investigators
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Andjela Jukic, MD, FEBO
Role: PRINCIPAL_INVESTIGATOR
Klinički Bolnički Centar Zagreb
Miro Kalauz, MD, PHD
Role: STUDY_DIRECTOR
Klinički Bolnički Centar Zagreb
Locations
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KBCZagreb
Zagreb, City of Zagreb, Croatia
Countries
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References
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Yonekawa Y, Kim IK. Pseudophakic cystoid macular edema. Curr Opin Ophthalmol. 2012 Jan;23(1):26-32. doi: 10.1097/ICU.0b013e32834cd5f8.
Russo A, Costagliola C, Delcassi L, Parmeggiani F, Romano MR, Dell'Omo R, Semeraro F. Topical nonsteroidal anti-inflammatory drugs for macular edema. Mediators Inflamm. 2013;2013:476525. doi: 10.1155/2013/476525. Epub 2013 Oct 21.
Han JV, Patel DV, Squirrell D, McGhee CN. Cystoid macular oedema following cataract surgery: A review. Clin Exp Ophthalmol. 2019 Apr;47(3):346-356. doi: 10.1111/ceo.13513.
Flach AJ. The incidence, pathogenesis and treatment of cystoid macular edema following cataract surgery. Trans Am Ophthalmol Soc. 1998;96:557-634. No abstract available.
Guo S, Patel S, Baumrind B, Johnson K, Levinsohn D, Marcus E, Tannen B, Roy M, Bhagat N, Zarbin M. Management of pseudophakic cystoid macular edema. Surv Ophthalmol. 2015 Mar-Apr;60(2):123-37. doi: 10.1016/j.survophthal.2014.08.005. Epub 2014 Sep 2.
Chu CJ, Johnston RL, Buscombe C, Sallam AB, Mohamed Q, Yang YC; United Kingdom Pseudophakic Macular Edema Study Group. Risk Factors and Incidence of Macular Edema after Cataract Surgery: A Database Study of 81984 Eyes. Ophthalmology. 2016 Feb;123(2):316-323. doi: 10.1016/j.ophtha.2015.10.001. Epub 2015 Dec 8.
Yau JW, Rogers SL, Kawasaki R, Lamoureux EL, Kowalski JW, Bek T, Chen SJ, Dekker JM, Fletcher A, Grauslund J, Haffner S, Hamman RF, Ikram MK, Kayama T, Klein BE, Klein R, Krishnaiah S, Mayurasakorn K, O'Hare JP, Orchard TJ, Porta M, Rema M, Roy MS, Sharma T, Shaw J, Taylor H, Tielsch JM, Varma R, Wang JJ, Wang N, West S, Xu L, Yasuda M, Zhang X, Mitchell P, Wong TY; Meta-Analysis for Eye Disease (META-EYE) Study Group. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012 Mar;35(3):556-64. doi: 10.2337/dc11-1909. Epub 2012 Feb 1.
Kim SJ, Schoenberger SD, Thorne JE, Ehlers JP, Yeh S, Bakri SJ. Topical Nonsteroidal Anti-inflammatory Drugs and Cataract Surgery: A Report by the American Academy of Ophthalmology. Ophthalmology. 2015 Nov;122(11):2159-68. doi: 10.1016/j.ophtha.2015.05.014. Epub 2015 Jun 26.
Jittpoonkuson T, Garcia PM, Rosen RB. Correlation between fluorescein angiography and spectral-domain optical coherence tomography in the diagnosis of cystoid macular edema. Br J Ophthalmol. 2010 Sep;94(9):1197-200. doi: 10.1136/bjo.2009.170589. Epub 2009 Dec 3.
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.
Yao Y, Li R, Du J, Long L, Li X, Luo N. Interleukin-6 and Diabetic Retinopathy: A Systematic Review and Meta-Analysis. Curr Eye Res. 2019 May;44(5):564-574. doi: 10.1080/02713683.2019.1570274. Epub 2019 Feb 4.
Funatsu H, Yamashita H, Noma H, Mimura T, Yamashita T, Hori S. Increased levels of vascular endothelial growth factor and interleukin-6 in the aqueous humor of diabetics with macular edema. Am J Ophthalmol. 2002 Jan;133(1):70-7. doi: 10.1016/s0002-9394(01)01269-7.
Malecaze F, Chollet P, Cavrois E, Vita N, Arne JL, Ferrara P. Role of interleukin 6 in the inflammatory response after cataract surgery. An experimental and clinical study. Arch Ophthalmol. 1991 Dec;109(12):1681-3. doi: 10.1001/archopht.1991.01080120065027.
Badaro E, Novais E, Prodocimo LM, Sallum JM. Spectral-domain optical coherence tomography for macular edema. ScientificWorldJournal. 2014;2014:191847. doi: 10.1155/2014/191847. Epub 2014 May 14.
Eriksson U, Alm A, Bjarnhall G, Granstam E, Matsson AW. Macular edema and visual outcome following cataract surgery in patients with diabetic retinopathy and controls. Graefes Arch Clin Exp Ophthalmol. 2011 Mar;249(3):349-59. doi: 10.1007/s00417-010-1484-9. Epub 2010 Sep 9.
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.
Kim SJ, Bressler NM. Optical coherence tomography and cataract surgery. Curr Opin Ophthalmol. 2009 Jan;20(1):46-51. doi: 10.1097/icu.0b013e3283199162.
Wielders LHP, Schouten JSAG, Winkens B, van den Biggelaar FJHM, Veldhuizen CA, Murta JCN, Goslings WRO, Kohnen T, Tassignon MJ, Joosse MV, Henry YP, Nagy ZZ, Rulo AHF, Findl O, Amon M, Nuijts RMMA; ESCRS PREMED study group. Randomized controlled European multicenter trial on the prevention of cystoid macular edema after cataract surgery in diabetics: ESCRS PREMED Study Report 2. J Cataract Refract Surg. 2018 Jul;44(7):836-847. doi: 10.1016/j.jcrs.2018.05.015.
Laursen SB, Erichsen JH, Holm LM, Kessel L. Prevention of macular edema in patients with diabetes after cataract surgery. J Cataract Refract Surg. 2019 Jun;45(6):854-869. doi: 10.1016/j.jcrs.2019.04.025.
Mamalis N. Prevention of cystoid macular edema after cataract surgery. J Cataract Refract Surg. 2018 Apr;44(4):419-420. doi: 10.1016/j.jcrs.2018.04.010. No abstract available.
Sarfraz MH, Haq RI, Mehboob MA. Effect of topical nepafenac in prevention of macular edema after cataract surgery in patients with non-proliferative diabetic retinopathy. Pak J Med Sci. 2017 Jan-Feb;33(1):210-214. doi: 10.12669/pjms.331.11644.
Other Identifiers
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CR ZAG 02/21 AG 8.1-16/183-2
Identifier Type: -
Identifier Source: org_study_id
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