Clinical trial NCT04856670: Assessing Diabetes Mellitus on Cytokine Analysis and Macular Edema Following FLACS
Official title: Assessing the Impact of Diabetes Mellitus on Anterior Chamber Cytokine Production and Postoperative Macular Edema in Patients Undergoing Femtosecond Laser-assisted Cataract Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystoid Macular Edema
Diabetes Mellitus
Cataract
Lead sponsor: Uptown Eye Specialists
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolling for Cataract surgery at Uptown Eye Specialists

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.

Detailed description: As discussed above.

Eligibility 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.
* Only one eye from each participant will be included in the study (the first one to be operated on).

Exclusion Criteria:

* Intravitreal anti-VEGF injection \< 3 months prior to cataract surgery
* Laser photocoagulation \< 3 months prior to cataract surgery
* Complications during manual cataract surgery or FLACS
* Current or previous ocular or systemic inflammation
* History of rheumatic or immune disease
* Poor pharmacologic mydriasis
* Corneal opacities
* Pseudoexfoliation syndrome
* Previous ocular surgery or trauma
* Use of topical or systemic steroids \< 6 months prior to surgery
* Prostaglandin analog eyedrop therapy
* Glaucoma
* Age-related macular degeneration

Primary outcomes:
measure: Aqueous humor concentrations of inflammatory mediators at the onset of manual cataract surgery and following femtosecond laser treatment
timeFrame: 1 day
Secondary outcomes:
measure: Prevalence of postoperative macular edema in control and diabetic participants
timeFrame: Post op day 1, week 1, month 1 and month 3
measure: Postoperative change in central retinal thickness
timeFrame: Post op day 1, week 1, month 1 and month 3
measure: Postoperative change in macular volume
timeFrame: Post op day 1, week 1, month 1 and month 3
measure: Microvascular changes and development of cystic macular lesions
timeFrame: Post op day 1, week 1, month 1 and month 3
measure: Best corrected visual acuity
timeFrame: Post op day 1, week 1, month 1 and month 3
measure: Prevalence and severity of postoperative flare
timeFrame: Post op day 1, week 1, month 1 and month 3
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Uptown Eye Speicialists
state: Otario
Study officials:
affiliation: Uptown Eye Specialists
name: sydney@emdi.ca Somani, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.