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The purpose of this study is to assess the effects of diabetes mellitus (DM) on anterior chamber cytokine production and postoperative macular edema in patients undergoing femtosecond laser-assisted cataract surgery (FLACS). Patients with DM routinely undergo FLACS, yet the majority of studies evaluating intraocular inflammation following femtosecond laser treatment have excluded this patient population. Importantly, DM alters the inflammatory status of the eye, which may influence the production of inflammatory mediators following femtosecond laser treatment and the development of postoperative macular edema. The results from this study will provide insight into the risks and benefits of FLACS in patients with DM.
As discussed above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control patients undergoing manual cataract surgery | As above |
| |
| Control patients undergoing FLACS | Femtosecond laser assisted cataract surgery |
| |
| Diabetic patients undergoing manual cataract surgery | As Above |
| |
| diabetic patients undergoing FLACS | As Above |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cataract surgery | Procedure | Cataract surgery- Manual or femtosecond laser assisted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aqueous humor concentrations of inflammatory mediators at the onset of manual cataract surgery and following femtosecond laser treatment | Cytokine concentration at time of cataract surgery | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of postoperative macular edema in control and diabetic participants | Macular edema post operatively | Post op day 1, week 1, month 1 and month 3 |
| Postoperative change in central retinal thickness |
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Inclusion Criteria:
Exclusion Criteria:
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Patients enrolling for Cataract surgery at Uptown Eye Specialists
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sohel Somani, MD, FRCSC | Contact | 416.292.0330 | sydney@emdi.ca |
| Name | Affiliation | Role |
|---|---|---|
| sydney@emdi.ca Somani, MD, FRCSC | Uptown Eye Specialists | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uptown Eye Speicialists | Brampton | Otario | L6Y0P6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28680705 | Background | Wu H, Hwang DK, Song X, Tao Y. Association between Aqueous Cytokines and Diabetic Retinopathy Stage. J Ophthalmol. 2017;2017:9402198. doi: 10.1155/2017/9402198. Epub 2017 Jun 7. | |
| 25811020 | Background | Dong N, Xu B, Wang B, Chu L, Tang X. Aqueous cytokines as predictors of macular edema in patients with diabetes following uncomplicated phacoemulsification cataract surgery. Biomed Res Int. 2015;2015:126984. doi: 10.1155/2015/126984. Epub 2015 Feb 25. |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D003920 | Diabetes Mellitus |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Central retinal thickness postoperatively
| Post op day 1, week 1, month 1 and month 3 |
| Postoperative change in macular volume | macular volume postoperatively | Post op day 1, week 1, month 1 and month 3 |
| Microvascular changes and development of cystic macular lesions | Slit lamp exam of microvascular changes and development of cystic macular lesions | Post op day 1, week 1, month 1 and month 3 |
| Best corrected visual acuity | Change in visual acuity overtime | Post op day 1, week 1, month 1 and month 3 |
| Prevalence and severity of postoperative flare | Slit lamp exam for prevalence and severity of postoperative flare | Post op day 1, week 1, month 1 and month 3 |
| 27801688 | Background | Agarwal A, Jacob S. Current and effective advantages of femto phacoemulsification. Curr Opin Ophthalmol. 2017 Jan;28(1):49-57. doi: 10.1097/ICU.0000000000000333. |
| 31262481 | Background | Favuzza E, Becatti M, Gori AM, Mencucci R. Cytokines, chemokines, and flare in the anterior chamber after femtosecond laser-assisted cataract surgery. J Cataract Refract Surg. 2019 Jul;45(7):910-914. doi: 10.1016/j.jcrs.2019.01.040. |
| 30528516 | Background | Liu YC, Setiawan M, Ang M, Yam GHF, Mehta JS. Changes in aqueous oxidative stress, prostaglandins, and cytokines: Comparisons of low-energy femtosecond laser-assisted cataract surgery versus conventional phacoemulsification. J Cataract Refract Surg. 2019 Feb;45(2):196-203. doi: 10.1016/j.jcrs.2018.09.022. Epub 2018 Dec 6. |
| 26659713 | Background | Wang L, Zhang Z, Koch DD, Jia Y, Cao W, Zhang S. Anterior chamber interleukin 1beta, interleukin 6 and prostaglandin E2 in patients undergoing femtosecond laser-assisted cataract surgery. Br J Ophthalmol. 2016 Apr;100(4):579-82. doi: 10.1136/bjophthalmol-2015-307586. Epub 2015 Dec 11. |
| 26331724 | Background | Chen H, Lin H, Zheng D, Liu Y, Chen W, Liu Y. Expression of Cytokines, Chmokines and Growth Factors in Patients Undergoing Cataract Surgery with Femtosecond Laser Pretreatment. PLoS One. 2015 Sep 2;10(9):e0137227. doi: 10.1371/journal.pone.0137227. eCollection 2015. |
| 28969616 | Background | Chen H, Zhang X, Liao N, Wen F. Assessment of biomarkers using multiplex assays in aqueous humor of patients with diabetic retinopathy. BMC Ophthalmol. 2017 Oct 2;17(1):176. doi: 10.1186/s12886-017-0572-6. |
| 26681390 | Background | 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. |
| 37847109 | Derived | Cioana M, Patodia Y, Tong L, Chiu HH, Tam ES, Somani S. Anterior chamber cytokine production and postoperative macular edema in patients with diabetes undergoing FLACS. J Cataract Refract Surg. 2024 Feb 1;50(2):160-166. doi: 10.1097/j.jcrs.0000000000001335. |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007905 | Lens Diseases |