Citicoline and Filtration Surgery
A Single-centre, Randomised, Double-blind Study to Assess the Efficacy of Citicoline Compared With Placebo on Visual Function in Glaucoma Patients Undergoing Subconjunctival Filtering Surgery for Glaucoma
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Lombardy
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Pavia、Lombardy、イタリア、27100
- Fondazione IRCCS Policlinico San Matteo di Pavia
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- age > 18 years
- Ability to understand the protocol and provide informed consent to participate in the study
- Diagnosis of primary or secondary open-angle glaucoma (PEX - PIG) and the need to undergo subconjunctival filtration surgery due to signs of morphological/functional progression of the condition or failure to achieve target pressure with medical or pre-surgical therapy.
The diagnosis of glaucoma is defined by the presence of typical ophthalmoscopic damage to the optic nerve head and the consequent visual field defect. In particular, a glaucomatous visual field defect will be considered as such if there is a cluster of 3 or more contiguous points in the pattern deviation plot with a probability of occurrence in the normal population of less than 5%, one of which has a probability of less than 1%, a pattern standard deviation with a probability of less than 5%, or a GHT result outside the normal limits.
- Early to moderate visual field defect, according to the Hodapp-Parrish-Anderson classification, i.e. with MD up to -12 dB, as determined by the Humphrey 24-2 SITA Standard computerised test.
- Rate of visual field defect progression > 0.5 dB/year, in the 2 years prior to surgery.
- At least 3 visual field examinations performed using standard perimetry in the 2 years prior to surgery.
Exclusion Criteria:
- Diagnosis of angle-closure glaucoma
- Previous glaucoma surgery (trabeculectomy, valve implantation or placement of other devices, cyclophotocoagulation)
- Previous vitreoretinal or corneal eye surgery
- Visual, neurological or general medical conditions that may affect the visual field, electrophysiological tests, OCT or A-OCT scans
- Systemic administration (oral or parenteral) of cerebral vasoactive drugs, neurotrophic agents, lutein, zeaxanthin, docosahexaenoic acid, ubiquinone and/or its derivatives, citicoline and/or its derivatives within 6 months prior to enrolment in the study
- Topical therapy with citicoline and/or its derivatives within 6 months prior to enrolment in the study
- Known or suspected allergy or sensitisation to the study product
- Pregnancy or breastfeeding
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:citicolina
The experimental group will be treated with citicoline in oral solution (Neurotidine, Omikron, Italy) at a dose of 10 ml per day, starting two weeks before surgery and continuing for the following 24 months.
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Citicoline is a mononucleotide composed of ribose, pyrophosphate, cytosine and choline. It is the natural intracellular precursor of phosphatidylcholine. As an intermediate in the synthesis of phosphatidylcholine, citicoline acts at a structural level, promoting the synthesis of membrane phospholipids and inhibiting their degradation. In addition to its structural action, it has a functional effect (as a neuroenhancer) in that it increases the synthesis of neurotransmitters such as noradrenaline, acetylcholine, serotonin and dopamine, which are involved in visual signal transmission at both the retinal and post-retinal levels. In addition to its structural effects, it also has a functional effect (as a neuroenhancer) in that it increases the synthesis of neurotransmitters such as noradrenaline, acetylcholine, serotonin and dopamine, which are involved in the transmission of visual signals at both the retinal and post-retinal levels. |
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プラセボコンパレーター:Placebo
The placebo arm will receive a solution consisting of the Neurotidine vehicle (placebo) according to the same dosing regimen and schedule.
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solution consisting of the Neurotidine vehicle (placebo)
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in the mean deviation (MD) index
時間枠:24 months after the operation
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The Mean Deviation (MD) perimetric index is a measure of the average differential light sensitivity of the visual field.
It is calculated as the sum of the defects found in the individual tested loci divided by the number of such loci.
A higher MD indicates greater damage to the visual field.
The MD index is used in conjunction with other perimetric indices to assess light sensitivity and the progression of glaucomatous damage
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24 months after the operation
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Change in the implicit P100 latency measured via PEV (visual evoked potentials)
時間枠:24 months after surgery
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24 months after surgery
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Change in p50 amplitude measured using PERG (retinal evoked potentials)
時間枠:24 months after surgery
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24 months after surgery
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Incidence of progression as determined by the Glaucoma Progression Analysis (GPA) programme
時間枠:24 months after surgery
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24 months after surgery
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Changes in the thickness of the retinal nerve fibre layer (RNFL) and ganglion cell layer (GCC) as measured by SD-OCT (Spectral Domain Optical Coherence Tomography)
時間枠:24 months after surgery
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24 months after surgery
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Change in choroidal hypoperfusion areas (dropouts) measured using A-OCT (Optical coherence tomography)
時間枠:24 months after surgery
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24 months after surgery
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Changes in the total score and sub-item scores on the NEI-VFQ-25 questionnaire (National Eye Institute Visual Function Questionnaire)
時間枠:24 months after surgery
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24 months after surgery
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CHIRCIT
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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