Assessing Diabetes Mellitus on Cytokine Analysis and Macular Edema Following FLACS
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
As discussed above.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Control patients undergoing manual cataract surgery As above |
Procedure: Cataract surgery
Cataract surgery- Manual or femtosecond laser assisted
|
| Control patients undergoing FLACS Femtosecond laser assisted cataract surgery |
Procedure: Cataract surgery
Cataract surgery- Manual or femtosecond laser assisted
|
| Diabetic patients undergoing manual cataract surgery As Above |
Procedure: Cataract surgery
Cataract surgery- Manual or femtosecond laser assisted
|
| diabetic patients undergoing FLACS As Above |
Procedure: Cataract surgery
Cataract surgery- Manual or femtosecond laser assisted
|
Outcome Measures
Primary Outcome Measures
- Aqueous humor concentrations of inflammatory mediators at the onset of manual cataract surgery and following femtosecond laser treatment [1 day]
Cytokine concentration at time of cataract surgery
Secondary Outcome Measures
- Prevalence of postoperative macular edema in control and diabetic participants [Post op day 1, week 1, month 1 and month 3]
Macular edema post operatively
- Postoperative change in central retinal thickness [Post op day 1, week 1, month 1 and month 3]
Central retinal thickness postoperatively
- Postoperative change in macular volume [Post op day 1, week 1, month 1 and month 3]
macular volume postoperatively
- Microvascular changes and development of cystic macular lesions [Post op day 1, week 1, month 1 and month 3]
Slit lamp exam of microvascular changes and development of cystic macular lesions
- Best corrected visual acuity [Post op day 1, week 1, month 1 and month 3]
Change in visual acuity overtime
- Prevalence and severity of postoperative flare [Post op day 1, week 1, month 1 and month 3]
Slit lamp exam for prevalence and severity of postoperative flare
Eligibility Criteria
Criteria
Inclusion Criteria:
-
All patients who are scheduled for manual cataract surgery or FLACS who have provided informed consent, in accordance with application regulations and guidelines.
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Only one eye from each participant will be included in the study (the first one to be operated on).
Exclusion Criteria:
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Intravitreal anti-VEGF injection < 3 months prior to cataract surgery
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Laser photocoagulation < 3 months prior to cataract surgery
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Complications during manual cataract surgery or FLACS
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Current or previous ocular or systemic inflammation
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History of rheumatic or immune disease
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Poor pharmacologic mydriasis
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Corneal opacities
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Pseudoexfoliation syndrome
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Previous ocular surgery or trauma
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Use of topical or systemic steroids < 6 months prior to surgery
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Prostaglandin analog eyedrop therapy
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Glaucoma
-
Age-related macular degeneration
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Uptown Eye Speicialists | Brampton | Otario | Canada | L6Y0P6 |
Sponsors and Collaborators
- Uptown Eye Specialists
Investigators
- Principal Investigator: sydney@emdi.ca Somani, MD, FRCSC, Uptown Eye Specialists
Study Documents (Full-Text)
None provided.More Information
Publications
- Agarwal A, Jacob S. Current and effective advantages of femto phacoemulsification. Curr Opin Ophthalmol. 2017 Jan;28(1):49-57. Review.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Wang L, Zhang Z, Koch DD, Jia Y, Cao W, Zhang S. Anterior chamber interleukin 1β, 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.
- 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.
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