Tesis

Perbandingan Keamanan Injeksi Intrakamera Moxifloxacin dengan Levofloxacin tanpa Dilusi pada Operasi Katarak = Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery.

Latar Belakang: Levofloxacin merupakan pilihan antibiotik intrakamera dan satusatunya yang digunakan pada operasi katarak di Indonesia selama beberapa dekade terakhir untuk profilaksis endoftalmitis. Meningkatnya resistensi bakteri okular terhadap levofloxacin mendorong perlunya disiapkan agen alternatif. Moxifloxacin, antibiotik golongan florokuinolon generasi yang lebih baru, memiliki potensi. Metode: Penelitian menggunakan desain randomized controlled trial (RCT) dengan lengan perlakuan: 0.1 cc moxifloxacin 0.5% dan 0.1 cc levofloxacin 0.5% intrakamera tanpa dilusi pada akhir operasi katarak. Luaran utama penelitian berupa endothelial cell density (ECD), central corneal thickness (CCT), central macular thickness (CMT), tekanan intraokular (TIO), tingkat peradangan segmen anterior, serta kejadian tidak diinginkan. Hasil: Pada Januari-Maret 2023, sejumlah 68 subjek dialokasikan secara acak ke kedua kelompok perlakuan. Tidak didapatkan perbedaan signifikan pada parameter dasar kedua kelompok. Pada pengukuran satu hari pascaoperasi, didapatkan TIO yang signifikan lebih tinggi pada lengan moxifloxacin (p=0.004; mean diff=4.9; IK95%=1.7 – 8.2). Tidak didapatkan perbedaan yang signifikan pada luaran utama lain berupa: ECD (p=0.314), CCT (p=0.882), dan reaksi peradangan (p=1.000). Hasil pengukuran satu minggu pascaoperasi menunjukkan tidak ada perbedaan antara kedua kelompok perlakuan: TIO (p=0.980), ECD (p=0.089), CCT (p=0.590), CMT (p=0.525). Pengukuran satu bulan juga tidak didapatkan perbedaan: TIO (p=0.127), ECD (p=0.264), CCT (p=0.322), CMT (p=0.753). Kesimpulan: Pada penelitian ini, didapatkan penggunaan 0.1 cc moxifloxacin intrakamera 0.5% menunjukkan profil keamanan yang mayoritas sebanding dengan levofloxacin. Namun, didapatkan parameter tekanan intraokular hari pertama pascaoperasi yang lebih tinggi secara signifikan pada kelompok yang menerima moxifloxacin.
Kata Kunci: antibiotik intrakamera, operasi katarak, levofloxacin, moxifloxacin, endothelial cell density, central corneal thickness, central macular thickness, tekanan intraokular


Purpose: Levofloxacin has been the choice of intracameral antibiotic and the only one used in cataract surgery in Indonesia for several decades for endophthalmitis prophylaxis. The increasing bacterial resistance to levofloxacin necessitates the preparation of alternative agents. Moxifloxacin, a newer generation fluoroquinolone antibiotic, has potential. Methods: The study employed a randomized controlled trial (RCT) design with two treatment arms: 0.1 cc intracameral 0.5% moxifloxacin and 0.1 cc intracameral 0.5% levofloxacin without dilution at the end of cataract surgery. The primary outcomes of the study included endothelial cell density (ECD), central corneal thickness (CCT), central macular thickness (CMT), intraocular pressure (IOP), anterior segment inflammation, and adverse events. Results: From January to March 2023, a total of 68 subjects were randomly allocated to the two treatment groups. No significant differences were found in the baseline parameters between the two groups. On the first-day postoperative measurement, a significantly higher IOP was observed in the moxifloxacin arm (p=0.004; mean diff=4.9; CI95%=1.7 – 8.2). No significant differences were found in other primary outcomes, including ECD (p=0.314), CCT (p=0.882), and inflammatory reactions (p=1.000). The one-week postoperative measurement showed no differences between the two treatment groups: IOP (p=0.980), ECD (p=0.089), CCT (p=0.590), and CMT (p=0.525). The onemonth measurement also revealed no differences: IOP (p=0.127), ECD (p=0.264), CCT (p=0.322), and CMT (p=0.753). Conclusion: In this study, the use of 0.1 cc intracameral 0.5% moxifloxacin demonstrated a safety profile that was mostly comparable to levofloxacin. However, a significantly higher intraocular pressure was observed on the first day postoperatively in the group receiving moxifloxacin.
Keywords: intracameral antibiotics, cataract surgery, levofloxacin, moxifloxacin, endothelial cell density, central corneal thickness, central macular thickness, intraocular pressure