Novel Triamcinolone Acetonide-Loaded Liposomes Topical Formulation for the Treatment of Cystoid Macular Edema After Cataract Surgery: A Pilot Study.

Alejandro Gonzalez-De la Rosa,Juan Carlos Altamirano-Vallejo,Juan Armendariz-Borunda,Jesus Javier Garcia-Bañuelos,Jose Navarro-Partida,Arturo Santos,Ada Gabriela Hernandez-Gamez

doi:10.1089/jop.2018.0101

Abstract

Purpose: To report tolerability, safety, and efficacy of a topical triamcinolone acetonide-loaded liposomes formulation (TA-LF) in targeting the macular area in patients with refractory pseudophakic cystoid macular edema (PCME).Methods: For tolerability, safety and efficacy evaluation, 12 eyes of 12 patients with refractory PCME were exposed to one drop of TA-LF (TA at 0.2%) every 2 h for 90 days or until best-corrected visual acuity (BCVA) was achieved. Intraocular pressure (IOP), slit lamp examination, and central foveal thickness (CFT) were analyzed at every visit.Results: Patients with refractory PCME under TA-LF therapy showed a significant improvement in BVCA and CFT without significant IOP modification (P = 0.94). On average CFT decreased to 206.75 ± 135.72 μm and BCVA improved to 20.08 ± 10.35 letters (P < 0.0005). BCVA was achieved at 10.58 ± 6.70 weeks (range 2–18). TA-LF was well tolerated in all cases. Neither ocular surface abnormalities nor adverse events were recorded.Conclusion: TA-LF was well tolerated and improved BCVA and CFT on patients with refractory PCME.

Highlights

Pseudophakic cystoid macular edema (PCME), called Irvine-Gass syndrome, is the most common cause of decreased central visual acuity (CVA) following a cataract surgery
For tolerability, safety and efficacy evaluation, 12 eyes of 12 patients with refractory pseudophakic cystoid macular edema (PCME) were exposed to one drop of triamcinolone acetonide-loaded liposomes formulation (TA-LF) (TA at 0.2%) every 2 h for 90 days or until best-corrected visual acuity (BCVA) was achieved
Refractory PCME was defined as central foveal thickness (CFT) ‡300 mm, measured by optical coherence tomography (Cirrus OCT Carl Zeiss, Meditec, Dublin, CA), and a registered increase in >8 mm or changes of –7.9 mm in CFT, after 4 weeks of topical nonsteroidal anti-inflammatory drugs (NSAIDs) therapy.[25,26]

Summary

Introduction

Pseudophakic cystoid macular edema (PCME), called Irvine-Gass syndrome, is the most common cause of decreased central visual acuity (CVA) following a cataract surgery. The incidence of clinical PCME, defined by symptomatic vision loss, is reported at 1.17%–4.04%.1. The incidence of PCME diagnosed by optical coherence tomography (OCT) can reach 10.9%.2. Onset of clinically significant PCME is generally 4–12 weeks after surgery and reaches its peak at 4–6 weeks postoperatively. Patients typically complain of impaired vision after an initial postoperative period of improvement.[3]. Many risk factors have been associated with PCME occurrence, including systemic diseases such as diabetes mellitus,[1,4] YAG capsulotomy, or preexisting conditions such as uveitis.[1,5] PCME pathogenesis is unclear, but involves the production of prostaglandins (PGs), cytokines, and other factors released during a surgical trauma that disrupt the blood–retina barrier and macular traction from prolapsed or incarcerated vitreous.[3]

Objectives

Methods

Results