Assessing Diabetes Mellitus on Cytokine Analysis and Macular Edema Following FLACS

NCT ID: NCT04856670

Last Updated: 2021-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-25

Study Completion Date

2021-09-15

Brief Summary

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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

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As discussed above.

Conditions

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Cystoid Macular Edema Diabetes Mellitus Cataract

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control patients undergoing manual cataract surgery

As above

Cataract surgery

Intervention Type PROCEDURE

Cataract surgery- Manual or femtosecond laser assisted

Control patients undergoing FLACS

Femtosecond laser assisted cataract surgery

Cataract surgery

Intervention Type PROCEDURE

Cataract surgery- Manual or femtosecond laser assisted

Diabetic patients undergoing manual cataract surgery

As Above

Cataract surgery

Intervention Type PROCEDURE

Cataract surgery- Manual or femtosecond laser assisted

diabetic patients undergoing FLACS

As Above

Cataract surgery

Intervention Type PROCEDURE

Cataract surgery- Manual or femtosecond laser assisted

Interventions

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Cataract surgery

Cataract surgery- Manual or femtosecond laser assisted

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uptown Eye Specialists

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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[email protected] Somani, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Uptown Eye Specialists

Locations

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Uptown Eye Speicialists

Brampton, Otario, Canada

Site Status

Countries

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Canada

Central Contacts

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Sohel Somani, MD, FRCSC

Role: CONTACT

416.292.0330

References

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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.

Reference Type BACKGROUND
PMID: 28680705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25811020 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27801688 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31262481 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30528516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26659713 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26331724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28969616 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26681390 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37847109 (View on PubMed)

Other Identifiers

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UptownEye1

Identifier Type: -

Identifier Source: org_study_id

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