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Cystoid Macular EdemaNCT04856670

Assessing Diabetes Mellitus on Cytokine Analysis and Macular Edema Following FLACS

An observational study of Cystoid Macular Edema and Diabetes Mellitus, run by Uptown Eye Specialists at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cystoid Macular Edema, Diabetes Mellitus, Cataract
What is being tested?
Cataract surgery
Type of treatment
Surgery or procedure
How many people
140 participants
Where
1 siteCanada
Study dates
25 May 2021to 15 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients enrolling for Cataract surgery at Uptown Eye Specialists

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Sohel Somani, MD, FRCSC contact

416.292.0330

sydney@emdi.ca

Canada1 site

  • Uptown Eye Speicialists

    Brampton, Otario, L6Y0P6

Other trials in Canada

About this study

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

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.

Read the detailed description

As discussed above.

Being tested
Cataract surgery
Medical subject headings
Macular Edema, Diabetes Mellitus, Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cataract surgeryProcedure or surgery

    Cataract surgery- Manual or femtosecond laser assisted

Study groups in NCT04856670
Study groupRoleWhat they receive
Control patients undergoing manual cataract surgeryAs above
Receives: Procedure: Cataract surgery
Control patients undergoing FLACSFemtosecond laser assisted cataract surgery
Receives: Procedure: Cataract surgery
Diabetic patients undergoing manual cataract surgeryAs Above
Receives: Procedure: Cataract surgery
diabetic patients undergoing FLACSAs Above
Receives: Procedure: Cataract surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 day

Secondary outcomes (6)

  1. Prevalence of postoperative macular edema in control and diabetic participants

    Macular edema post operatively

    Measured: Post op day 1, week 1, month 1 and month 3

  2. Postoperative change in central retinal thickness

    Central retinal thickness postoperatively

    Measured: Post op day 1, week 1, month 1 and month 3

  3. Postoperative change in macular volume

    macular volume postoperatively

    Measured: Post op day 1, week 1, month 1 and month 3

  4. Microvascular changes and development of cystic macular lesions

    Slit lamp exam of microvascular changes and development of cystic macular lesions

    Measured: Post op day 1, week 1, month 1 and month 3

  5. Best corrected visual acuity

    Change in visual acuity overtime

    Measured: Post op day 1, week 1, month 1 and month 3

  6. Prevalence and severity of postoperative flare

    Slit lamp exam for prevalence and severity of postoperative flare

    Measured: Post op day 1, week 1, month 1 and month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2021
  2. Study start25 May 2021 (estimated)
  3. Primary completion15 Sep 2021 (estimated)
  4. Study completion15 Sep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04856670
Sponsor's protocol ID
UptownEye1
Status last verified
May 2021
First submitted
11 Nov 2020
Last updated
12 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28680705

  • 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.

    PubMed 25811020

  • 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.

    PubMed 27801688

  • 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.

    PubMed 31262481

  • 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.

    PubMed 30528516

  • 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.

    PubMed 26659713

  • 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.

    PubMed 26331724

  • 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.

    PubMed 28969616

  • 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.

    PubMed 26681390

  • Cioana 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.

    PubMed 37847109

Questions about this trial

What is this clinical trial studying?

An observational study of Cystoid Macular Edema and Diabetes Mellitus, run by Uptown Eye Specialists at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sohel Somani, MD, FRCSC (416.292.0330, sydney@emdi.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aqueous humor concentrations of inflammatory mediators at the onset of manual cataract surgery and following femtosecond laser treatment (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04856670, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.

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