Assessing Diabetes Mellitus on Cytokine Analysis and Macular Edema Following FLACS

• Conditions: Cystoid Macular Edema; Cataract; Diabetes Mellitus
• Interventions: Procedure: Cataract surgery

• Registration Number: NCT04856670
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-23
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-12
• Study Start: 2021-05-25
• Primary Completion: 2021-09-15
• Study Completion: 2021-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic patients undergoing manual cataract surgery	Cataract surgery	As Above
diabetic patients undergoing FLACS	Cataract surgery	As Above
Control patients undergoing manual cataract surgery	Cataract surgery	As above
Control patients undergoing FLACS	Cataract surgery	Femtosecond laser assisted cataract surgery

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Uptown Eye Speicialists; 🇨🇦 Brampton, Otario, Canada