Assessing Diabetes Mellitus on Cytokine Analysis and Macular Edema Following FLACS

Study Overview
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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.

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

Conditions
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Cystoid Macular Edema, Diabetes Mellitus, Cataract

Intervention / Treatment
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* Procedure: Cataract surgery


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control patients undergoing manual cataract surgery<br>As above | Procedure: Cataract surgery<br>* Cataract surgery- Manual or femtosecond laser assisted<br>|
| Control patients undergoing FLACS<br>Femtosecond laser assisted cataract surgery | Procedure: Cataract surgery<br>* Cataract surgery- Manual or femtosecond laser assisted<br>|
| Diabetic patients undergoing manual cataract surgery<br>As Above | Procedure: Cataract surgery<br>* Cataract surgery- Manual or femtosecond laser assisted<br>|
| diabetic patients undergoing FLACS<br>As Above | Procedure: Cataract surgery<br>* Cataract surgery- Manual or femtosecond laser assisted<br>|

What is the study measuring?
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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 | 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 | Macular edema post operatively | Post op day 1, week 1, month 1 and month 3 | 
| Postoperative change in central retinal thickness | Central retinal thickness postoperatively | Post op day 1, week 1, month 1 and month 3 | 
| Postoperative change in macular volume | macular volume postoperatively | Post op day 1, week 1, month 1 and month 3 | 
| 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 | 
| Best corrected visual acuity | Change in visual acuity overtime | Post op day 1, week 1, month 1 and month 3 | 
| 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 |