Assessing Diabetes Mellitus on Cytokine Analysis and Macular Edema Following FLACS

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04856670
• Other study ID #: UptownEye1
• Status: Not yet recruiting
• Start date: May 25, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: May 2021
• Source: Uptown Eye Specialists
• Contact: Sohel Somani, MD, FRCSC
• Phone: 416.292.0330
• Email: sydney[@]emdi.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

As discussed above.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cystoid Macular Edema
• Diabetes Mellitus
• Edema
• Macular Edema

Intervention

Procedure:
• Cataract surgery
Cataract surgery- Manual or femtosecond laser assisted

Locations

Country	Name	City	State
Canada	Uptown Eye Speicialists	Brampton	Otario

Sponsors (1)

Lead Sponsor	Collaborator
Uptown Eye Specialists

Country where clinical trial is conducted

Canada, 

References & Publications (9)

Agarwal A, Jacob S. Current and effective advantages of femto phacoemulsification. Curr Opin Ophthalmol. 2017 Jan;28(1):49-57. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Wang L, Zhang Z, Koch DD, Jia Y, Cao W, Zhang S. Anterior chamber interleukin 1ß, 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Postoperative change in central retinal thickness	Central retinal thickness postoperatively	Post op day 1, week 1, month 1 and month 3
Secondary	Postoperative change in macular volume	macular volume postoperatively	Post op day 1, week 1, month 1 and month 3
Secondary	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
Secondary	Best corrected visual acuity	Change in visual acuity overtime	Post op day 1, week 1, month 1 and month 3
Secondary	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