PCME Prevention in Patients With NPDR

Summary

Pseudophakic cystoid macular edema (PCME), or Irvine-Gass syndrome, is retinal thickening of the macula, which usually develops within 3 months after surgery, with a peak incidence between 4 and 6 weeks. Despite recent improvements in surgical techniques, PCME remains one of the most common causes of visual decline following an uneventful cataract surgery. Symptoms of PCME usually are blurred vision, metamorphopsia, loss of contrast sensitivity, and central scotomas. PCME usually responds well to medical therapy or may resolve spontaneously but carries a risk of permanent vision loss or loss of contrast sensitivity. There is wide discrepancy in opinions about the most effective antiinflammatory drops for the prevention of PCME. Patients with diabetes mellitus (DM) have attracted special interest because of higher incidence of cataract and increased risk for developing CME after cataract surgery. The optimum antiinflammatory prophylaxis for PCME in patients with nonproliferative diabetic retinopathy (NPDR) remains unknown.

Purpose of this study is to determine the efficacy of topical bromfenac and topical dexamethasone on intraocular concentration of interleukin-6 (IL6) and the incidence of pseudophakic cystoid macular edema (PCME) after cataract surgery in patients with nonproliferative diabetic retinopathy (NPDR).

Conditions

• Cystoid Macular Edema Following Cataract Surgery

Interventions

DRUG

Bromfenac Ophthalmic 0.09% Ophthalmic Solution

topical bromfenac (0.9 mg/mL) 2x daily 7 days before the surgery

DRUG

Dexamethasone Ophthalmic

topical dexamethasone (1 mg/mL) 2x daily 7 days before the surgery

DRUG

Placebo

topical placebo (artificial tears substitute) 2x daily before the surgery

PROCEDURE

Phacoemulsification surgery (PHACO)

About 0.1-0.2 mL of aqueous humor will be collected at the beginning of the cataract surgery (PHACO) through paracentesis, aqueous will then be transported in dry ice with a dedicated box to the laboratory and stored at -80C until the analysis. IL6 concentration will be analyzed with Human IL6 Quantikine Elisa kit (R\&D System).

Sponsors & Collaborators

• University of Zagreb

  collaborator OTHER

• Klinički Bolnički Centar Zagreb

  lead OTHER

Principal Investigators

• Andjela Jukic, MD, FEBO · Klinički Bolnički Centar Zagreb

• Miro Kalauz, MD, PHD · Klinički Bolnički Centar Zagreb

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-01

Primary Completion

2021-10-01

Completion

2022-01-01

Countries

• Croatia

Study Locations