PCME Prevention in Patients With NPDR

• Status: Enrolling by invitation
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Klinički Bolnički Centar Zagreb
• Collaborator: University of Zagreb
• Treatments: BB 1101; Bromfenac; Dexamethasone; Dexamethasone acetate; Ophthalmic Solutions

Criteria

Inclusion Criteria:

• clinical diagnosis of mild to moderate nonproliferative diabetic retinopathy (EDTRS) and

• senile cataract grade II nuclear/cortical or posterior subcapsular (LOCS III)

Exclusion Criteria:

• anterior segment pathology (pseudoexfoliation syndrome, corneal opacities),

• posterior segment pathology (diabetic macular edema, previous diabetic macular edema treatment, previous retinal photocoagulation therapy, age related macular degeneration, retinal vascular diseases or history of uveitis)

• intraoperative complications (posterior capsular rupture, vitreus loss, intraocular lens not implanted in the capsular bag),

• postoperative complications (leaking incision, increased intraocular pressure, corneal edema or inflammation),

• therapy for glaucoma,

• patients on antihypertensive therapy, topical or systemic NSAIDs or steroids,

• previous steroid responders or hypersensitivity to the NSAID drug class,

• previous ocular trauma and intraocular surgery