Assessing Diabetes Mellitus on Cytokine Analysis and Macular Edema Following FLACS

Uptown Eye Specialists

Status: Unknown

Conditions: Cataract; Diabetes Mellitus; Cystoid Macular Edema

Treatments: Procedure: Cataract surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04856670

UptownEye1

Details and patient eligibility

About

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.

Full description

As discussed above.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

140 participants in 4 patient groups

Control patients undergoing manual cataract surgery

Description:

As above

Treatment:

Procedure: Cataract surgery

Control patients undergoing FLACS

Description:

Femtosecond laser assisted cataract surgery

Treatment:

Procedure: Cataract surgery

Diabetic patients undergoing manual cataract surgery

Description:

As Above

Treatment:

Procedure: Cataract surgery

diabetic patients undergoing FLACS

Description:

As Above

Treatment:

Procedure: Cataract surgery