Assessing Diabetes Mellitus on Cytokine Analysis and Macular Edema Following FLACS

May 10, 2021 updated by: Uptown Eye Specialists

Assessing the Impact of Diabetes Mellitus on Anterior Chamber Cytokine Production and Postoperative Macular Edema in Patients Undergoing Femtosecond Laser-assisted Cataract Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

As discussed above.

Study Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sohel Somani, MD, FRCSC
  • Phone Number: 416.292.0330
  • Email: sydney@emdi.ca

Study Locations

  • Canada
    • Otario
      • Brampton, Otario, Canada, L6Y0P6
        • Uptown Eye Speicialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients enrolling for Cataract surgery at Uptown Eye Specialists

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aqueous humor concentrations of inflammatory mediators at the onset of manual cataract surgery and following femtosecond laser treatment
Time Frame: 1 day
Cytokine concentration at time of cataract surgery
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of postoperative macular edema in control and diabetic participants
Time Frame: Post op day 1, week 1, month 1 and month 3
Macular edema post operatively
Post op day 1, week 1, month 1 and month 3
Postoperative change in central retinal thickness
Time Frame: Post op day 1, week 1, month 1 and month 3
Central retinal thickness postoperatively
Post op day 1, week 1, month 1 and month 3
Postoperative change in macular volume
Time Frame: Post op day 1, week 1, month 1 and month 3
macular volume postoperatively
Post op day 1, week 1, month 1 and month 3
Microvascular changes and development of cystic macular lesions
Time Frame: Post op day 1, week 1, month 1 and month 3
Slit lamp exam of microvascular changes and development of cystic macular lesions
Post op day 1, week 1, month 1 and month 3
Best corrected visual acuity
Time Frame: Post op day 1, week 1, month 1 and month 3
Change in visual acuity overtime
Post op day 1, week 1, month 1 and month 3
Prevalence and severity of postoperative flare
Time Frame: Post op day 1, week 1, month 1 and month 3
Slit lamp exam for prevalence and severity of postoperative flare
Post op day 1, week 1, month 1 and month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uptown Eye Specialists

Investigators

  • Principal Investigator: sydney@emdi.ca Somani, MD, FRCSC, Uptown Eye Specialists

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 25, 2021

Primary Completion (Anticipated)

September 15, 2021

Study Completion (Anticipated)

September 15, 2021

Study Registration Dates

First Submitted

November 11, 2020

First Submitted That Met QC Criteria

April 19, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UptownEye1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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