Cataract, Cystoid Macular Edema, Diabetes Mellitus
Conditions
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.
Interventions
PROCEDURECataract surgery
Cataract surgery- Manual or femtosecond laser assisted
Sponsors
Uptown Eye Specialists
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative change in central retinal thickness | Post op day 1, week 1, month 1 and month 3 | Central retinal thickness postoperatively |
| Postoperative change in macular volume | Post op day 1, week 1, month 1 and month 3 | macular volume postoperatively |
| 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 |
| 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 |
| 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 |
Countries
Canada
Contacts
Primary ContactSohel Somani, MD, FRCSC
Outcome results
None listed