Assessing Diabetes Mellitus on Cytokine Analysis and Macular Edema Following FLACS
Assessing the Impact of Diabetes Mellitus on Anterior Chamber Cytokine Production and Postoperative Macular Edema in Patients Undergoing Femtosecond Laser-assisted Cataract Surgery
1 other identifier
observational
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2020
CompletedFirst Posted
Study publicly available on registry
April 23, 2021
CompletedStudy Start
First participant enrolled
May 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2021
CompletedMay 12, 2021
May 1, 2021
4 months
November 11, 2020
May 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Prevalence of postoperative macular edema in control and diabetic participants
Post op day 1, week 1, month 1 and month 3
Postoperative change in central retinal thickness
Post op day 1, week 1, month 1 and month 3
Postoperative change in macular volume
Post op day 1, week 1, month 1 and month 3
Microvascular changes and development of cystic macular lesions
Post op day 1, week 1, month 1 and month 3
Best corrected visual acuity
Post op day 1, week 1, month 1 and month 3
- +1 more secondary outcomes
Study Arms (4)
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
Interventions
Cataract surgery- Manual or femtosecond laser assisted
Eligibility Criteria
Patients enrolling for Cataract surgery at Uptown Eye Specialists
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uptown Eye Speicialists
Brampton, Otario, L6Y0P6, Canada
Related Publications (10)
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.
PMID: 28680705BACKGROUNDDong 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.
PMID: 25811020BACKGROUNDAgarwal A, Jacob S. Current and effective advantages of femto phacoemulsification. Curr Opin Ophthalmol. 2017 Jan;28(1):49-57. doi: 10.1097/ICU.0000000000000333.
PMID: 27801688BACKGROUNDFavuzza 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.
PMID: 31262481BACKGROUNDLiu 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.
PMID: 30528516BACKGROUNDWang 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.
PMID: 26659713BACKGROUNDChen 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.
PMID: 26331724BACKGROUNDChen 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.
PMID: 28969616BACKGROUNDChu 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.
PMID: 26681390BACKGROUNDCioana 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.
PMID: 37847109DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
sydney@emdi.ca Somani, MD, FRCSC
Uptown Eye Specialists
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2020
First Posted
April 23, 2021
Study Start
May 25, 2021
Primary Completion
September 15, 2021
Study Completion
September 15, 2021
Last Updated
May 12, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share