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"ABSTRAKTujuan tesis ini adalah mengetahui pengaruh suplementasi sitikolin 1000 mg per hari selama 4 minggu terhadap hasil elektroretinografi pada pasien NPDR non-proliferative diabetic retinopathy . Desain penelitian ini adalah uji klinis acak terkontrol tersamar ganda. Tiga puluh delapan mata yang memenuhi kriteria inklusi dan eksklusi dirandomisasi untuk masuk ke dalam kelompok plasebo P-NPDR atau sitikolin 1000 mg S-NPDR . Pada akhir penelitian didapatkan 18 mata pada kelompok sitikolin dan 16 mata pada kelompok plasebo. Keluaran primer penelitian ini adalah nilai amplitudo P50 dan N95 PERG within group dan intergroup yang dinilai pada baseline dan 4 minggu paska pemberian intervensi. Analisis hasil didapatkan pada S-NPDR didapatkan perbaikan nilai rerata amplitudo N95 sebelum terapi, 4.85 1.9-10.3 V, dan setelah terapi, 5.7 1.9-17.1 V, P = 0.04 . Terdapat kecenderungan perbaikan amplitudo P50 yang lebih baik pada kelompok T-NPDR dan perbaikan amplitudo N95 yang lebih baik pada S-NPDR yang tidak bermakna secara statistik P = 0.45; P = 0.35.

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ABSTRACT

The purpose of this study was to determine the effect of citicoline 1000 mg oral supplementation given for 4 weeks on electroretinography abnormalities in patients with NPDR non proliferative diabetic retinopathy . The study design was a double blind randomized controlled clinical trial. Thirty eight patients who matched the inclusion and exclusion criteria were randomized into two groups the plasebo P NPDR and citicoline C NPDR . In the end, there were 18 eyes in citicoline group and 16 eyes in plasebo group. The primary outcome was P50 and N95 amplitude in PERG within group and intergroup which were taken at the baseline and 4 weeks after treatment. Results at the end of treatment, the N95 amplitude in C NPDR showed improvement, 4.85 1.9 10.3 V, before treatment to 5.7 1.9 17.1 V, after treatment with P 0.04. In P NPDR showed positive trend in P50 amplitude while in C NPDR showed positive trend in N95 amplitude, but these values were not statistically significant P 0.45 P 0.35."

"Latar belakang. Penelitian ini bertujuan mendapatkan gambaran data dasar nilai normal pERG, ketebalan RNFL dan GCIPL pada subjek normal dan subjek dengan POAG derajat early, moderate dan severe serta menilai korelasi antara masing-masing modalitas pemeriksaan.Metode. Penelitian potong lintang yang dilakukan pada 36 mata normal dan 42 mata dengan POAG (derajat early, moderate dan severe) usia 18-60 tahun di RSCM. Semua subjek menjalani pemeriksaan oftalmologi dasar dan pemeriksaan penunjang yaitu Humphrey standard automated perimetry, OCT peripapil dan makula menggunakan CirrusTM dan pERG menggunakan MonPack One dari Metrovision.Hasil. Berdasarkan data normal didapatkan ketebalan rerata RNFL 106,3 ± 11,0 μm, ketebalan rerata GCIPL 83,3 ± 3,5 μm, waktu implisit P50 52,7ms , amplitudo P50 7,9 (3,4 – 15,6) μV, waktu implisit N95 101,3 ± 5,2 ms, amplitudo N95 10,6 (6,0 – 18,7) μV. Dibandingkan dengan kelompok POAG early didapatkan perbedaan bermakna pada ketebalan RNFL (p = 0,007), amplitudo P50 (p = 0,005) dan amplitudo N95 (p = 0,004), tanpa perbedaan bermakna pada ketebalan GCIPL, sedangkan pada kelompok moderate dan severe didapatkan perbedaan pada semua variabel (p<0,05). Korelasi positif sedang dan lemah ditemukan pada kelompok normal antara ketebalan RNFL dengan amplitudo P50 dan N95, tidak ada korelasi hasil pemeriksaan pERG dengan ketebalan GCIPL.Kesimpulan. Pattern ERG adalah pemeriksaan objektif yang dapat membedakan antara kelompok normal dengan POAG, pemeriksaan pERG pada POAG harus memperhatikan floor effect.

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Introduction. The study aims to evaluate and compare the pERG result, RNFL and GCIPL thickness in normal group to the groups with early, moderate and severe POAG and evaluate its correlation.

Methods. Cross-sectional study was done on 36 normal eyes and 42 eyes with POAG (mild, moderate and severe),subjects with age range of 18-60 years old in RSCM Kirana. Each group underwent complete basic ophthalmology examinations, Humphrey standard automated perimetry, peripapillary and macular OCT CirrusTM and MonPack One pERG from Metrovision.

Results. The data on normal group were as follow: RNFL thickness 106,3 ± 11,0 μm, GCIPL thickness 83,3 ± 3,5 μm, P50 implicit time 52,7 ms , P50 amplitude 7,9 (3,4 – 15,6) μV, N95 implicit time 101,3 ± 5,2 ms, N95 amplitude 10,6 (6,0 – 18,7) μV. Significant differences were found in RNFL thickness (p = 0,007), P50 amplitude (p = 0,005) and N95 amplitude (p = 0,004) in the early POAG group compared to the normal group, meanwhile on moderate and severe group all of the variable examination result including the GCIPL thickness were significantly different (P<0,05). Positive moderate and weak correlations were found between RNFL thickness in normal group with P50 and N95 amplitude, no correlation between pERG result with GCIPL thickness.

Conclusion. Pattern ERG is an objective tools to differentiate between normal and POAG subjects, pERG examination in POAG group especially the severe group needs to evaluate the floor effect by doing the prior OCT examination."

"Tujuan mengetahui pengaruh sitikolin 1000 mg per hari selama 60 hari terhadap hasil pattern electroretinography, ketebalan sel ganglion dan lapang pandang pasien NAION non-arteritic anterior ischemic optic neuropathy fase kronik. Metode Uji klinis acak terkontrol tersamar ganda dilakukan pada 38 subyek penelitian. Randomisasi membagi subyek menjadi 2 kelompok yaitu 18 subyek kelompok sitikolin S-NAION dan 20 subyek plasebo P-NAION. Analisis dilakukan pada 17 subyek penelitian di tiap kelompok. Hasil Terjadi peningkatan ? amplitudo P50 30 hari di kelompok S-NAION 0,775 2,6 V , namun tidak bermakna secara statistik bila dibandingkan dengan kelompok P-NAION p = 0,182. Terjadi perbaikan ? amplitudo N95 60 hari di kelompok S-NAION -0,356 2,992 V, namun tidak bermakna secara statistik bila dibandingkan dengan kelompok P-NAION p = 0,779. Pemberian sitikolin tidak menunjukkan perubahan ketebalan sel ganglion retina. Terjadi peningkatan ? mean deviation 60 hari di kelompok S-NAION 3,13 6,467 dB, namun tidak bermakna secara statistik bila dibandingkan dengan kelompok P-NAION p = 0,344. Kesimpulan Sitikolin cenderung meningkatkan ? amplitudo P50 dan N95 serta ? mean deviation pada NAION fase kronik.

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Purpose to determine the effect of 1000 mg citicoline each day given for 60 days on pattern electroretinography, retinal ganglion cell thickness and visual field in chronic phase NAION non arteritic anterior ischemic optic neuropathy patients. Methods Double masked randomized clinical trial were performed in 38 patients. Randomization divided the patients into 2 groups of 18 subjects in the citicoline group C NAION and 20 subjects in the placebo group P NAION . The analysis was performed on 17 subjects in each group.

Results There were increament of amplitude P50 30 days in C NAION group 0,775 2,6 V, but statistically insignificant compared to P NAION p 0,182. There were also improvement of amplitude N95 60 days in C NAION group 0,356 2,992 V, but statistically insignificant compared to P NAION p 0,779. Citicoline supplementation did not show any changes in retinal ganglion cell thickness. There were improvement of mean deviation 60 days in C NAION group 3,13 6,467 dB, but statistically insignificant compared to P NAION p 0,344. Conclusions Citicoline tends to increase the amplitude of P50 and N95 and mean deviation in chronic phase NAION."