Tujuan: Menilai efektifitas dan efek samping fluorometolon (full) 0,1% dalam penatalaksanaan dry eye tipe defisiensi akuosMetode: Penelitian ini merupakan studi uji Minis prospektif, randomisasi dan tersamar ganda di sebuah panti wredha. Sebanyak 35 subjek yang diikutsertakan dalam penelitian ini merupakan dry eye defisiensi akuos tipe non-Sjogren. Subjek diacak ke dalam 2 kelompok yaitu kelompok I mendapatkan fluorometolon 0,1% dan kelompok 2 mendapatkan hidroksipropil metilselulosa 0,3% (kontrol). Penilaian efektifitas berdasarkan skor gejala, tes Schirmer tanpa anestesi, fluorescein break up time (FBUT), pewarnaan fluoresein dan sensitivitas kornea dilakukan pada hari 0, 14 dan 28. Pemeriksaan derajat metaplasia skuamosa dilakukan 2 kali yaitu pada hari 0 dan 28. Penilaian efek samping dilihat dari tekanan intraokular dan katarak. Analisis statistik dilakukan di dalam dan antar kelompok.Hasil: Kedua kelompok mengalami perbaikan gejala, tanda klinis dan derajat metaplasia yang bermakna dari data dasar. Namun tidak didapatkan perbaikan bermakna antara hari 14 dan 28 pada kelompok kontrol. Hasil tes Schirmer dan FBUT lebih baik secara bermakna di kelompok fluorometolon dibanding kelompok kontrol pada hari 14 dan 28. Perbaikan pewarnaan fluoresein lebih berkurang secara bermakna pada kelompok fluorometolon dibanding kelompok kontrol pada hari 28. Skor gejala, sensitivitas kornea dan perbaikan derajat metaplasia tidak berbeda bermakna antar kelompok namun cenderung lebih balk pada kelompok fluorometolon. Efek samping berupa rasa Iengket dan gatal pada ke dua kelompok tidak berbeda bermakna. Tekanan intraokular cenderung stabil dan tidak didapatkan progresifitas katarak selama penelitian.Kesimpulan: Fluorometolon 0,1% topikal memberikan perbaikan gejala dan tanda Minis yang bermakna pada dry eye defisiensi akuos tipe non-Sjogren.
Purpose: To evaluate the effectiveness and safety of fluorometholone (fml) 0.1% in non-Surgery dry eye syndrome.Methods: A prospective, randomized, double-masked, clinical trial was conducted in a nursing home. Thirty-five non-Sjogren dry 'eye subjects were included in the study. The subjects were randomized into two groups. Group 1 subjects received fluorometholone 0.1% and group 2 received hydroxypropyl methylcellulose (control). The eye symptom severity score, Schirmer test without anesthesia values, fluorescein break up time (FBUT), fluoresecein staining scores and corneal sensitivity were evaluated before treatment, 14 and 28 days after start the treatment. The degree of squamous metaplasia was evaluated before treatment and day 28. Intraocular pressure, cataract formation and other side effects were recorded to evaluate the safety in both groups. Statistical analyses were performed within and between groups.Results: Both groups had significant differences compared with their baseline measurements in all of the parameters. However, subjects in the control group showed no significantly improvements between day 14 and day 30. There were no significant differences between groups on symptom severity score and corneal sensitivity on day 14 and 28. The degree of squamous metaplasia was not significantly different between groups on day 28. The FML group had significantly better Schirmer test value and FBUT on days 14 and 28 compared to control group. The fml group subjects also had significantly lower fluorescein staining on days 28. The side effects detected in fml group were sticky and itchy, comparable to control group. Intraocular pressure was stable and no progression of cataract formation.Conclusion: Topical fluorometholone 0.1% had a clearly beneficial effect both on subjective and objective clinical parameters of non-Sjogren dry eye patients. |
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